The level of sacroiliac joint dysfunction was 33.3% in the study population. Accordingly to the surveys were used in this study, the neuropathic pain level, also the presence of kinesiophobia and depression were significantly higher in the group with sacroiliac joint dysfunction. Additionally, functional capacity was observed worse. A prospective cross-sectional study.To evaluate the prevalence of sacroiliac joint dysfunction in patients with lumbar disc hernia and examine the variations in clinical parameters cause by this combination.Although one of the many agents leading to lumbar pain is sacroiliac dysfunction, little progress has still been made to evaluate mechanical pain from sacroiliac joint dysfunction within the context of differential diagnosis of lumbar pain.Two hundred thirty-four patients already diagnosed with lumbar disc hernia were included in the study. During the evaluation, sacroiliac joint dysfunction was investigated using specific tests, pain levels with a Visual Analog Scale, and the presence of neuropathic pain using Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale. Other clinical assessments were performed using the Beck Depression Inventory, Health Assessment Questionnaire, and Tampa Kinesiophobia Scale.P < 0.05). No significant difference was observed in pain intensity assessed using a Visual Pain Scale between the groups (P > 0.05), but the level of neuropathic pain was significantly higher in the group with dysfunction (P < 0.05). In the group with sacroiliac joint dysfunction, the presence of depression was significantly higher (P = 0.009), functional capacity was worse (P < 0.001), and the presence of kinesophobia was higher (P = 0.02).63.2% of patients were female and 36.8% were male. Mean age was 46.72 ± 11.14 years. The level of sacroiliac joint dysfunction was 33.3% in the research population. In terms of sex distribution, the proportion of women was higher in the group with sacroiliac joint dysfunction (Our study results will be useful in attracting the attention of clinicians away from the intervertebral disc to the sacroiliac joint in order to avoid unnecessary and aggressive treatments.Level of Evidence: 2 Seventy percent of cases occur in the 30 to 50 age group, while 10% appear after 60. LDH in childhood is very rare.5 The sacroiliac joint (SIJ) was first described as a joint causing lumbar pain by Goldwaith and Osgood in 1905.6 In a study from 1909 involving SIJ dissection in 50 cadavers and seven cases, Albee described this as a genuine, mobile joint, and reported that lumbar pain and sciatica emerge when it is injured.8One of the many agents leading to lumbar pain is sacroiliac dysfunction, the prevalence of which, based on clinical assessments, is 15% to 30%.The joint has its own particular biomechanical characteristics, anatomical variations, and diffuse neural innervation. The clinical presentation and pain patterns of sacroiliac joint dysfunction (SJD) are therefore still controversial.The purpose of this study was to establish the prevalence of SJD in patients with LDH and to examine the variations in clinical parameters cause by this combination.This cross-sectional study investigated patients aged 20 to 60 presenting to the Okmeydani Training and Research Hospital Physiotherapy and Rehabilitation Clinic, Turkey, due to lumbar-leg pain between January and April 2015. Two hundred thirty-four patients with diagnoses of LDH confirmed by clinical and radiological evaluations were enrolled in the study.Patients aged 20 to 60, diagnosed with LDH, with cognitive levels sufficient to complete the assessment forms, and agreeing to participate were enrolled. Patients with lumbar pain, the etiology of which was suspected to be inflammatory in character, with structural vertebral deformity or fracture, with severe and progressive neurological deficit, with a history of severe psychiatric disease, with substance and/or alcohol dependence, with uncontrolled diabetes mellitus (DM), malignancy, spinal infection or a history of vertebral surgery, and pregnant subjects were excluded.Demographic characteristics such as patients’ age, height, body weight (BW), body mass index (BMI), marital status, education level, and occupational status, and information concerning history of trauma, and the character, duration, and site of pain were investigated and noted on a case report form.Before undergoing physical examination, all patients were evaluated in terms of pain threshold measurements using a Visual Analogue Scale (VAS), using the Leeds Assessment of Neuropathic Symptoms and Signs Pain Scale (LANSS) to the determine character of pain, with the Beck Depression Inventory (BDI) for psychological state, using the Health Assessment Questionnaire (HAQ) for quality of life and the Tampa Scale for Kinesiophobia for aversion to movement.Lumbar spine flexion, extension, and right-left lateral flexion ranges of motion were determined using a universal goniometer and clinical tests were evaluated at physical examination.13 In addition, all patients were asked about SIJ pain , and the data were recorded.In terms of clinical tests, Lasegue test, contralateral Lasegue, and the femoral nerve stretch test were used to determine LDH and six provocation tests  tests) for the SIJ. Based on the data from previous studies, patients with three or more positive provocation tests were diagnosed with SJD.A power analysis using the formula n = t2pq /d2 was performed to determine the sample size. Based on those data we concluded that a minimum of 174 and a maximum of 322 patients would be required to achieve significant results, and 234 patients were enrolled.P < 0.05. The analysis was performed on SPSS  for Windows 16.0 software.The study data were expressed as mean plus standard deviation (SD) for constant variables values and as number and percentage for categoric variables. The chi-square test was used to analyze categoric variables. Results were evaluated at a 95% confidence interval at a significance level of The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) guideline has been implemented in this manuscript.Two hundred thirty-four patients, 148 females (63.2%) and 86 males (36.8%), with a clinical diagnosis of LDH and with disk protrusion and/or extrusion identified at magnetic resonance imaging (MRI) were included in the study. The presence of SJD was determined in 78 (33.3%) of the 234 patients using provocation tests. Dysfunction in the SIJ was determined on the right in 52.6% of patients and on the left in 47.4%. Patients were divided into groups, with or without SJD, and then compared.P > 0.05). A significant difference between the groups was observed only in terms of sex, the presence of SJD being higher in women (P = 0.005). Demographic data are shown in Table The ages of the 234 subjects in the study ranged between 20 and 60, the mean age being 46.72 ± 11.14. There was no statistically significant difference between the groups in terms of height, body weight, BMI, age, marital status, education, or employment (P < 0.05). No statistically significant variation was observed at a comparison of the location of pain and pain arising with prolonged standing (P > 0.05). The findings are shown in Table Comparisons were performed between the groups in terms of location of pain, pain in the hip (SIJ), remaining standing for long periods, walking some distance and pain when rising from a seated position, getting out of a car or walking upstairs. Statistically, significant variation was determined in terms of the location of pain and prolonged standing .No statistically significance was determined between the groups in terms of duration of pain, VAS at rest, VAS during activity, and nocturnal VAS scores .Although greater lumbosacral joint and SIJ degeneration were determined at radiological imaging in the SJD group, the differences were not statistically significant . Examination of lumbar disk hernia levels revealed L5–S1 disk herniation in 53% of patients, L4–5 in 38.5%, L3–4 in 8.1%, and L2–3 in 0.4%. No significant variation was determined between the two groups .Examination of lumbar MRI findings revealed hernial protrusion in 94.9% (n = 222) of patients and extrusion in 5.1% (n = 12), but no statistically significant difference was observed between the two groups . However, a statistically significant difference was observed in tenderness along the sciatic nerve  . No statistically significant difference was determined between the groups in terms of lumbar range of motion, hand-ground distance sensory deficit (root level), or decreased deep tendon reflexes in the patellar and Achilles tendons .Tests aimed at assessing LDH revealed no statistically significant difference between the groups in terms of Lasegue test, contralateral Lasegue, and the femoral nerve stretch test , while comparison of SIJ provocation tests revealed significant variation in increasing pain with the Compression Test and the FABER, Gaenslen, Posterior Shear Test (POSH), and Sacral Thrust tests (P < 0.001).No statistically significant difference was determined between the groups at evaluation of extremity length measurements (P < 0.05).Significant variation was observed between the groups in terms of the Beck Depression Scale, LANSS pain scale, HAQ, and Tampa kinesophobia scale , compression and distraction tests, were highly sensitive and specific.13 However, all of these studies reported that should be used multiple tests for the diagnosis of SIJD and individual tests exhibited low reliability. Dreyfuss et al14 examined SI joint tests in a group consisting of asymptomatic individuals and observed symptoms of SIJD in 20% of asymptomatic patients. van der Wurff et al15 reported that the presence of three or more positive provocation tests in patients with pain deriving from the SI joint varied between 65% and 93%. Six provocation tests used in the diagnosis of SJD were performed on all patients in this study, and SJD was confirmed in the presence of three or more positive results.Some studies have reported a decrease of at least 80% in VAS scores with local anesthesia injection guided by fluoroscopy, the gold standard technique for the diagnosis of SJD syndrome.21 Madani et al9 investigated 202 patients aged 19 to 70, with LDH, determined at imaging and with physical findings of lumbosacral root irritation and reported SJD in 146 (72.3%) subjects. The authors reported that the estimated prevalence of SJD being significantly higher (72.3%) than that in previous studies19 might be explained in terms of the importance of non-joint factors that cannot be identified with SJD blocks.9The prevalence of SJD has been reported at 24% to 72.3% in previous studies.et al9 reported involvement on the left in 95.2% of patients with SJD, on both right and left in 2.1% and on the right in 2.7%. Slipman et al20 reported SJD on the right in 45% of cases, on the left in 35%, and bilateral in 20%.The prevalence of SJD in this study was 33.3%. SJD was located on the right in 52.6% of patients and on the left in 47.4%. Madani et al22 reported the need to establish a pain chart in the diagnosis of SJD and showed on the basis of that chart that pain in patients with SJD was generally unilateral in the posterior superior iliac spine region. Pain diffusion map data are consistent with those of several previous clinical studies.29Fortin et al15 reported that in SJD the patient directly indicated the painful joint. Weksler et al21 concluded that pain in 50 cases of lumbar pain and LDH diagnosed with SJD was distributed at 36% in the hip, inguinal in 26%, in the knee in 14%, in the calf in 14%, and in the foot in 10%.In terms of pain distribution, van der Wurff et al30 reported hip pain in 94% of patients with SJD, lumbar pain in 72%, lower extremity pain in 50%, leg pain descending below the knee in 28%, and pain in the foot in 1%.Slipman Analysis of pain location in the patients in our study population revealed that subjects most commonly presented with lumbar-leg pain, if no discrimination is made between right and left sides, and with lumbar and lumbar-left leg pain if right and left sides are differentiated. When the SJD and non-SJD groups were analyzed separately, greater lumbar-leg pain was observed in both groups than lumbar pain. However, when right and left side pain location differentiation was performed, right or left lumbar-leg pain was greater than lumbar pain in the SJD group, while in the non-SJD group lumber pain was greater than right or left lumbar-leg pain.Evaluation of pain in the hip and gluteal region revealed no hip pain in 28.6% of patients, while in subjects with hip pain, levels of right and left side pain was similar, but slightly higher on the left. In the SJD group, the pain was present in 73.3% of patients, and pain in the left hip and the gluteal region was more prevalent than pain on the right. In the non-SJD group, the distributions of patients with no hip pain and of patients with pain in the right or left hip were approximately equal.Evaluation of the BDI results in the patient population showed that subjects without depression constituted the majority in both groups. In the SJD group, the presence of moderate and severe depression was significantly higher, while in the non-SJD group, the non-depression group was significantly higher. These findings show that the prevalence of depression was higher in the SJD group and that such patients should be particularly evaluated in terms of depression.31Since our study evaluated patients with LDH, which directly concerns the neural stems, and considering the proximity of the SIJ to neural structures, patients were also evaluated using LANSS for neuropathic pain. The findings revealed neuropathic pain in 39.7% of the SJD group and in 21.2% of the non-SJD group. On the basis of these data, a significant difference was determined the prevalence of neuropathic pain was greater in the group with SJD. In addition, evaluation of sensitivity along the sciatic nerve  revealed 46.2% positivity in the SJD group and 26.3% positivity in the non-SJD group. On the basis of these findings, the presence of sensitivity along the sciatic nerve  was significantly higher in the group with SJD. In the literature, the presence of sensitivity and neuropathic pain along the sciatic nerve is thought to be associated with neighboring piriformis muscle spasm and sciatic nerve irritation secondary to SJD pathologies.32 compared patients diagnosed with lumbar radiculopathy and patients with SJD, assessing McGill pain scores, visual analog scores, and short form-36 quality of life scales. They concluded that there was no statistically significant difference between the patients with SJD and those with lumbar radiculopathy. The HAQ was used to evaluate the quality of life in our population and in agreement with the literature, statistically significant elevation was determined the group with LDH and SJD, indicating poor quality of life.Cheng and FerranteAversion to movement, evaluated using the Tampa Scale for Kinesophobia, was significantly prevalent in the group with SJD, similarly to the prevalence of poor quality of life. Our scan of the literature revealed that the Tampa Scale for Kinesophobia and BDI had not previously been used in studies of patients with SJD. We think that in the light of the determination in this study of the fact that the presence of SJD accompanying LDH causes an increase in the prevalence of both kinesophobia and depression, these two conditions should be assessed separately both in daily practice and in future studies.There are a number of significant limitations to this study. The inclusion of patients with lumbar pain secondary to LDH may have led to the relation between the prevalence of SJD and other clinical entities being overlooked. In addition, fluoroscopy-guided local anesthesia injection into the SIJ, one of the criteria set out in the diagnosis of SJD by the International Association for the Study of Pain in 1994, was not performed. However, we think that the appropriate patient number in the study population, an upper age limit of 60 being imposed, rheumatological diseases being regarded as an exclusion criterion and patient examinations and all assessments being performed by a single physician being under equivalent conditions for all patients increase the reliability and validity of the data.One of the many agents leading to lumbar pain is sacroiliac dysfunction, the prevalence of which, based on clinical assessments, is 15% to 30%.The level of sacroiliac joint dysfunction was 33.3% in our research population. In terms of sex distribution, the proportion of women was higher in the group with sacroiliac joint dysfunction.The level of neuropathic pain, the presence of depression and kinesophobia were significantly higher in the group with dysfunction.In addition, functional capacity was worse in the group with sacroiliac joint dysfunction.In conclusion, SJD is a pathology accompanying disc degeneration at a level of approximately one in three in patients with LDH, and this condition should be considered when planning a conservative treatment protocol for patients with lumbar or lumbar-leg pain. SIJ involvement should be determined using SIJ provocation tests in patients with LDH, particularly when conservative treatment is unsuccessful. In this way, the attention of physicians and surgeons can be diverted from the intervertebral disk to the SIJ for the avoidance of unnecessary lumbar region surgery based on pain indications.


The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) is a reliable and valid assessment instrument for measuring neck-related symptoms and functional limitations in people with neck pain, but a Turkish version of it had not been published. The purpose of this study was to investigate the adaptation, validity, and intrarater reliability of the Turkish version of the ProFitMap-neck. Two hundred and thirty-five individuals with chronic neck pain were enrolled in the study. Intrarater reliability was assessed by intraclass correlation coefficient (ICC) and Cronbach’s alpha was calculated for internal consistency. For concurrent validity, ProFitMap-neck scores were compared with neck disability index (NDI) and visual analoguepain scale (VAS) scores using Pearson’s correlation coefficient analysis. The ProFitMap-neck, NDI, VAS, and short form health survey (SF-36) were administered to all participants.For intrarater analysis, ICC ranged between 0.72 and 0.84. The total score was 0.83, indicating excellent reliability. The correlation of the ProFitMap-neck with NDI and VAS was 0.71 and 0.68, respectively, indicating good concurrent validity. The ProFitMap-neck is an evaluation instrument with sufficient validity and reliability to be used for evaluating Turkish patients with neck pain. Use of this scale can reveal how, how often, and how much these patients’ pain affects their symptoms and functional activities. Neck pain occurs commonly throughout the world and causes substantial disability and economic cost [1]. The prevalence of neck pain was reported to be 20.3% in 2017 and it varies between countries [2]. Pathophysiological mechanisms are lacking and risk factors are multifactorial for most cases of neck pain . A reliable and responsive assessment of the pain of patients with neck pain is an essential prerequisite to setting realistic goals for treatment and rehabilitation, as well as for assessing the outcome of treatment interventions [5]. Therefore, a questionnaire for measuring pain, other symptoms, and functional limitations is necessary to decide on the most effective treatment method for neck pain. An important property of questionnaires is how well they mirror typical problems of the target group [6]. In addition, neck pain patients should be assessed in a biopsychosocial framework for the planning of treatment programs. According to the international classification of functioning, disability and health (ICF), questionnaires encompassing body functions, activity, and participation allow treatment programs to be composed more accurately [7].Clinical trials showed that even if neck pain symptoms are mild and comorbidities are few, patients could have functional limitations in their daily life [8]. For this reason, pain and functional limitations are distinct domains and recommended to be measured separately for detecting differences in each domain [9]. Distinct items that focus on different domains in the same index, such as pain/symptoms and functional limitations in the neck disability index (NDI), Copenhagen neck functional disability scale, Bournemouth neck questionnaire, and Northwick Park neck pain questionnaire, may hamper detailed evaluation of treatment . The disadvantage of having different domains in the same index is the lack of change in total score, although the domains within change separately, because the patient can improve in one domain and worsen in another. Thus, it appears advantageous to have separate indices for pain/symptoms and functional limitations, as well as a total score.In the light of this information, questionnaires for neck pain need to include separate indices. The Profile Fitness Mapping neck questionnaire (ProFitMap-neck) meets this need. This questionnaire has the advantage of detailed assessment of symptoms and functional limitations since it consists of 2 subscales: a symptom scale, with a further subdivision in separate indices for intensity and frequency of symptoms, and a functional limitation scale [12]. There are some neck pain questionnaires that have been confirmed to be valid and reliable for Turkish patients, for example the NDI, Bournemouth neck questionnaire, and Northwick Park neck pain questionnaire [13]. However, these questionnaires have limited coverage of ICF components and categories of importance [14]. For example, while the Bournemouth neck questionnaire includes only neck pain, difficulties concentrating, and emotional engagements [15], the NDI includes symptoms from the rest of the body, such as headaches, and difficulties sleeping and concentrating [16]. On the other hand, the ProFitMap-neck includes the neck, arm, and hand; symptoms apart from pain ; symptoms from the rest of the body ;and mental/cognitive and emotional engagements [6]. The advantages of the ProFitMap-neck are that it evaluates the patients in a biopsychosocial framework comprehensively and mirrors the improvements in patients in different domains. However, there is noTurkish version. For this reason, the aim of the present study was to investigate the reliability and validity of a Turkish version of the ProFitMap-neck in neck pain patients.This study was conducted in City name/Country name. It was approved by the XXX University, Non-Interventional Clinical Trials Ethics Committee  and registered in the Clinical Trials database (NCT03415737). Written permission was obtained from questionnaire developers for the Turkish version of the ProFitMap-neck, and the translation and cultural adaptation were carried out according to the procedure established by Beaton et al.[17]. Details of each step are explained in the following part. Two hundred andforty native Turkish speaking individuals participated in the study. The sample size of this study was chosen as 5 times the number of items used in the scale [18]. The study was completed performing the reliability and validity analysis. The flowchart of the study was shown in Figure. Details of each step are explained below: Step 1: Liaison with the ProFitMap-neck’s developers . The purpose was to determine whether there were any attempts in progress to develop a Turkish version of the instrument. Contact was established via mail with Dr. Björklund at the Department of Occupational and Public Health Sciences, University of Gävle, Sweden, the first author of the original validation study of the ProFitMap-neck [12]Step 2: Translation (English to Turkish) The original English form of the questionnaire was translated into Turkish by 2 native Turkish speakers with good command of English. One of them was a physiotherapist and was aware of the study, while the other was an English linguistic scientist unaware of the concepts. Step 3: Back-translation (Turkish to English)The 2 versions of the Turkish translation were combined into a single translation by the 2 translators. This combined Turkish version of the questionnaire was then translated back into English by 2 bilingual translators (back-translation). The bilingual translators were unaware of the study.Step 4: SynthesisThe expert committee consisted of 2 physiotherapists, 2 bilingual translators, and a specialist in public health science. The committee reviewed all versions. The content of the original and reverse-translated English versions was compared and differences were noted. The reviewers commented on the differences and a synthesis of these differences was created. Step 5: Consensus buildingFollowing the evaluation of the resultant translations for English–Turkish language and cultural adaptation by the expert committee, the prefinal form of the questionnaire was created. Step 6: Pilot testingThe comprehensiveness of the questionnaire was evaluated in a pilot group of 30 people  and they were asked about the comprehensibility of each item in the questionnaire . Step 7: Development of the final version After the pilot group completed the questionnaire, the final form of the questionnaire was established by the committee based on the findings.Individuals were recruited from the Department of XXX at the XXX University and from the campus of the university, via advertisement. Individuals 18 to 65 years of age who had a primary problem of neck pain that had persisted for 12 weeks or more, who had good verbal communication, and who had the ability to read and write in Turkish were included. The exclusion criteria were having vestibular, neurological, musculoskeletal, and cardiovascular disease; having a history of cervical surgery; and being pregnant.Informed consent was obtained from all individual participants included in the study.The ProFitMap-n was designed by an expert group of health professionals at the Alfta Rehab Center, a rehabilitation clinic in mid-Sweden, in 1992–1994 for measuring symptoms and functional limitations in people with the most prevalent categories of neck pain. This questionnaire consists of 2 subscales: a symptom scale (27 items) and a functional limitation scale (20 items). The symptom scale also consists of 2 indices of separate aspects of symptomatology, the intensity and the frequency of the symptoms, and the functional limitation scale yields 1 function index. Frequency (f) is the answer to howoftenthe symptom is felt . Intensity (i) is the answer to how much the symptom is felt . The answers for the functional limitation scale range from 1 = very good, no problem, very satisfying, very likely, to 6 = very bad, very difficult/impossible, very dissatisfying, very unlikely. The result of each index is expressed as the percentage of the maximum score, where 100% is the best possible result. Thus, 3 index percentages and a total percentage are obtained from this questionnaire. See Björklund et al. for the questionnaire form and method of score calculation of the ProFitMap-neck [12]. The NDI is the most commonly used outcome measure for neck pain and it contains 10 subsections consisting of severity of pain, personal care, lifting, reading, headache, concentration, work, driving, sleeping, and leisure activities. The questions are measured on a 6-point scale from 0  to 5 . The numeric response for each item is summed for a score varying from 0 (no disability) to 50  . A VAS is a vertical line, 100 mm in length, with the bottom of the line indicating “no pain” and top of the line the worst pain; the possible score lies between 0 and 10. The VAS was used to assess the subjects’ pain [20]. This survey instrument is designed for use in clinical practice and research, health policy investigations, and general population examinations [21]. The SF-36 includes one multiitem scale that assesses 8 health concepts with 36 items: physical functioning (PF), general health (GH), emotional role limitations (ERL), vitality (V), physical role limitations (PRL), social functioning (SF), and bodily pain (BP). Each question’s score was coded, summed, and transmuted to a scale of 0  to 100  [22]. Internal consistency: Cronbach’s alpha was utilized for the internal consistency analysis. A cronbach’s alpha value of 0.80 or higher is considered excellent [23].Intrarater Reliability: For the intrarater reliability, the questionnaire was completed twice. The period between measurements was 7 days. Intrarater reliability was determined by using the intraclass correlation coefficient (ICC). ICCs can vary from 0.00 to 1.00, with values of 0.60 to 0.80 regarded as evidence of good reliability and those above 0.80 indicating excellent reliability [23].The concurrent validity was examined by comparing the total scores of the ProFitMap-neck with those of the NDI, VAS, and SF-36. Concurrent validity coefficients were regarded as follows: r ≥ 0.81–1.0 as excellent, 0.61–0.80 very good, 0.41–0.60 good, 0.21–0.40 fair, and 0–0.20 poor [23]. The relation was evaluated with Pearson’s correlation coefficient.Two hundred and forty people, aged between 18 and 65, participated in the study. Five patients were excluded because they filled out the questionnaire incorrectly, and thus the final number of the participants was 235. The mean age of the included subjects was 33.49 ± 15.17 years, and 164 (69.8%) were female and 91 (30.2%) were male. Detailed demographic data are listed in Table 1.The intrarater analysis was performed with 102 of the 235 patients after 1 week, and they received no treatment for 7 days.During the translation and back-translation, the main changes made to the symptom scale were question sentences were added to items 25 and 26 in order to make them easier to understand. For the functional limitation scale, the word “weight ” was added to items 6 and 7 to make “carry weight ” and “lift weight ”. Moreover, “throw” was changed to “throw stuff”. The word “sweater” was culturally adapted to “T-shirt/sweater ” because of the changeable weather conditions in Turkey (Appendix).For the reliability analysis, Cronbach’s alpha values of the ProFitMap-neck indices were recorded as follows: for symptom frequency index 0.894, for symptom intensity index 0.899, for functional index 0.943, and for total score 0.959, indicating that the questionnaire has high internal consistency (Table 2). The ICC values ranged from 0.725 to 0.841 (Table 3). The ICC values of the ProFitMap-neck were recorded as follows: for symptom frequency index 0.841, for symptom intensity index 0.725, for functional index 0.797, and for total score 0.830 (Table 3). According to the ICC values, the ProFitMap-neck test-retest (intrarater) results were excellent. The correlation coefficients between the ProFitMap-neck indices and the criterion questionnaires are presented in Table 4. For validity, the correlation of total scores of the ProFitMap-neck with the NDI was r: 0.710 and with the VAS was r: 0.68. The correlations between the symptom frequency index, symptom intensity index, and functional index, which were the subparameters of the ProFitMap-neck indices, and the NDI were r: 0.682, r: 0.612, and r: 0.654, respectively. Based on these results, the ProFitMap-neck had a very good correlation with the NDI. The correlations between the total scores of the ProFitMap-neck and the SF-36 indices varied between poor and good (0.18–0.52) (Table 4). This study demonstrated the reliability and validity of the Turkish version of theProFitMap-neck. The analyses support the reliability and validity of the instrument for Turkish neck pain patients. The present study shows that the Turkish version of the ProFitMap-neck has good internal consistency. This was compatible with the internal consistency level usually found and deemed appropriate for other measures (>0.7) .For intrarater reliability, ICCs were only reported in the original and Portuguese versions [12], [24]. While 210 patients were enrolled in the original version, 180 female patients with chronic neck pain participated in the Brazilian (Br) Portuguese version. Strong reliability was identified by high ICCs (ICC > 0.75). In the present study, we found that the total ICC value was 0.830 at 1week for the intrarater reliability intervals . The ICC value for each index varied between 0.72 and 0.84. As a result, it appears that the Turkish version of the ProFitMap-neck is highly stable over time. The ICC values ranged from 0.81 to 1 in the Br-Portuguese version of ProFitMap-neck [24]. The researchers indicated that the Br-ProFitMap-neck had high levels of reliability for total score and indices. They also explained that the possible reason for the high reliability in their study was the short time interval between test and retest (at least 5 h), which allows for close control of the clinical stability of the patients. In addition, they indicated that future studies should test the Br-ProFitMap-neck by using longer test–retest intervals (between 1 and 2 weeks).We had a 1-week time interval between test and retest and excellent reliability in our study. Therefore, our study evaluated fluctuations in the functioning/disability and symptoms that are important for clinical trials as stated in the validity study of the Br-ProFitMap-neck. For validity, the present study assessed the correlation between the ProFitMap-neck and the NDI, VAS, and SF-36. We demonstrated the Pearson’s correlation coefficient value of the ProFitMap-neck with the NDI was 0.71. Furthermore, all indices of the ProFitMap-neck showed good correlation with the NDI . The Pearson’s correlation coefficient values showed that the correlation of the Turkish version of ProFitMap-neck with the NDI and VAS was high.In the Br-Portuguese version of the ProFitMap-neck, the correlation values between the domains of the Br-ProFitMap-neck and NDI varied from 0.56 to 0.71 [24]. The results of our study were similar to those for the Br-Portuguese version of the ProFitMap-neck. Furthermore, our results are consistent with those of the study of the original version [12].The correlation value between the ProFitMap-neck and VAS was 0.68 in our study.When we analyzed the other Turkish version scales, the correlations between total score of the mean VAS and Copenhagen neck functional disability scale, neck pain and disability scale, Northwick Park pain questionnaire were r = 0.72, r = 0.83, r = 0.78, respectively [13]. Aslan et al. showed that the relation value between NDI and VAS was 0.62 in their study [15]. These results are similar to our current study. The correlations between the SF-36 and ProFitMap-neck, we found fair and good correlations. In particular, the correlation value between the ProFitMap-neck and the emotional role limitation indices of SF-36 was 0.18, which indicates poor correlation. This correlation value in the original study was 0.38 [12]. The perceived disability of patients included in our study was 13.02 , whereas in the original study it was 14.2 (indicates mild disability). We think that a minimal level of disability may not cause emotional role limitations. The correlation values between the ProFitMap-neck and the other subscales of SF-36 were also similar to those of the original study. Neck pain occurs commonly throughout the world and causes substantial disability and economic cost. The pain and disability associated with neck pain have a large impact on individuals and their families, communities, healthcare systems, and businesses. Economic consequences include the cost of healthcare, reduced work productivity, work absenteeism, and insurance . Therefore, choosing the most convenient assessment tool can make the planning of treatment programs for patients with neck pain easier. The separate scores for specific domains, preferably combined with an overall judgment score, as in the ProFitMap-neck, may be considered advantageous not only in clinical practice but also in research. Therefore, the current study has importance for biopsychosocial examinations of Turkish populations with neck pain.In conclusion, the ProFitMap-neck is an evaluation instrument with sufficient validity and reliability to be used for evaluating Turkish neck pain patients. Use of this scale can reveal how, how often, and how much patients’ pain affects their symptoms and functional activities, which will play a key role in managing patients with neck pain.The authors thank Dr. Martin Björklund  for his permission to translate the ProFitMap-neck into Turkish, and the members of the committee  for their cooperation. The study was approved by Ethics Committee  and registered in the Clinical Trials database (NCT03415737). No support has been received for this study.The authors report no conflicts of interest. Written informed consent was obtained from all study participants.


In 2018, a novel approach to reduce pectoralis spasm from sub- pectoral breast implant surgery was published called the INTRAPEC.1 In this study, we more formally examine the effectiveness of the ultrasound-guided INTRAPEC injection to control postoperative pectoralis major spasm and pain following breast surgery with sub-pectoral implantation.We employed a simple postoperative spasm and pain record to collect data on 17 patients, all of whom received INTRAPEC and erector spinae plane blocks as a part of an opioid- free anesthetic. All breast surgeries were completed with LMA general anesthesia, preserving spontaneous ventilation.Of the 17 study participants, 13 (76.4%) reported spasm scores less than 3 for the entire 2-day study period and, at most time points, patients reported a median score for pain of 2, with IQRs ranging from 1 to 7.The study results suggest that the INTRAPEC injection is a simple, low-cost, low-risk, and effective technique that controls post- operative spasm following breast surgery involving sub-pectoral implantation. Given evidence-driven and/or state-mandated initiatives to decrease or avoid perioperative opioid use, regional blockade of the medial and lateral pectoral nerve has numerous advantages for perioperative pain management of the patient undergoing subpectoral implantation. The INTRAPEC technique, introduced in 2018, can be used for a variety of breast surgeries such as revision of existing implants or first-time breast augmentation spasm control.1 The advantages over traditional techniques, such as the PECs 1 block, make this technique appealing. Other techniques exist to treat postoperative spasms but have not been formally studied in their effectiveness in spasm prevention. The introduction of the PECs 1 technique by R. Blanco was a significant step forward in targeted pectoralis muscle pain as it sought to block the muscle spasm at the nerve level. The technique involves a discrete placement of local anesthetic between the pectoralis major and minor, to hopefully contact and block the median and lateral pectoral nerves.4 However, due to the lack of consistency in anatomical placement of these nerves, even an ultrasound-guided injection correctly placed between the muscle planes will not guarantee a nerve block. The presence of existing subpectoral implants also makes this technique challenging and somewhat risky, even in experienced hands. A subtle needle advancement causing intrusion into an implant could have considerable consequences. Importantly, regarding the placement of the PECs 1 technique, the surgically induced implant pocket comprises the exact location of the local anesthetic deposition. As a consequence of this, before final implantation, a washout of this pocket by the surgical team means a dramatic reduction of any local anesthetic deliberately placed there. This inevitably will cause a significant reduction in blockade of the median and lateral pectoral nerves. Lastly, unlike the INTRAPEC, the PECs 1 block fails to provide intraoperative muscle compliance during electrocautery. These reasons make the PECs 1 technique virtually obsolete in its application for subpectoral implantation. Predecessors to the INTRAPEC have been employed postoperatively with some success, suggesting proof of concept.6 However, these techniques have only been investigated for postoperative pain and spasm control. Neither of these techniques have been formally studied for preoperative employment for the purposes of postoperative spam control effectiveness.Previous efforts to ameliorate pectoralis spasm-related postoperative pain have involved intraoperative botulinum toxin injection, postoperative neurectomy of the medial and lateral pectoral nerve, and/or pre- or postoperative blockade of the medial and lateral pectoral nerve.Enrollment and data collection took place at the office-based surgical center. This center has 2 operating areas and various patient care and screening regions. The center functions as a cosmetic and wellness office, as well as fully functioning surgical theater. Following study approval, women scheduled to undergo subpectoral implantation under general anesthesia, with airway maintenance via a laryngeal mask airway and combined erector spinae/INTRAPEC regional blockade for intra- and postoperative analgesia were asked to participate. All participants were physically qualified for office-based breast surgery, and thus were physical status 1 or 2 only, with no allergies to medications used in the protocol. Informed consent for anesthesia included verbal understanding of the risks, benefits, and alternatives to general anesthesia with regional blockade including the intrapack technique. Additionally, informed consent for data collection included verbalized understanding of the risks/benefits/alternatives to providing data about pain and spasm for the 48 hours after surgery. Lastly, an explanation regarding the distinction between pain, such as burning or stinging pain associated with the incision, and muscle spasm, eg, the uncontrollable sensation and irritation of the pectoralis muscle contractions, was provided. All study participants demonstrated verbal understanding of their contributions to the data collection, specifically, their accuracy in record production.7 Following the ESP blocks, the patients were assisted into a supine position and preoxygenated. General anesthesia was induced, and a laryngeal mask airway placed. The anterior chest was exposed and every effort made to preserve the surgeons markings. A covered linear probe was paired with a Terason 3300  and used to obtain a transverse view of the pectoralis major muscle. Attention was paid to the surrounding deeper structures, noting the lung pleura and known regional vasculature. If an existing subpectoral implant were present, it was sonographically mapped to mark its position under the muscle and observe its casual dimensions. The general condition and any notable attributes of the musculature were reported to surgeon. Upon location of the largest and most inferior portion of the pectoralis major muscle, skin prep was applied again to the needle entry point. A 20-gauge block needle  was introduced, in plane, directly into the thick portion of the muscle. Total doses of low concentration local anesthesia varied slightly depending on safe total dosing guidelines, based primarily on weight and remainder of local anesthetic following completion of the ESP block. All patients received at least 15 mL of total volume for the INTRAPEC. The final concentration of each INTRAPEC injection was ropivacaine 0.25% and lidocaine 0.5% with epinephrine 1:200,000 into each muscle belly. Patients also received 4 mg of IV Zofran and 10 mg of IV Decadron as part of a multimodal anesthesia plan. Sequential compression devices were applied to the lower extremities, and the surgeon then proceeded to create a subpectoral dual plane using a lighted retractor and placed the final breast implants. Care was used to avoid injury to the medial pectoral, lateral pectoral nerve. And finally, the subpectoral implant was placed and surgery completed. Spontaneous ventilation was maintained throughout, and no opiates were administered to any patient. Postoperatively, patients were transferred to the postanesthesia care unit and observed until ready for discharge to home. Patients were provided with oxycodone/APAP  as needed for analgesia and cyclobenzaprine (10 mg tablet PO q 8 hours) as needed for muscle spasms that occurred despite ESP/INTRAPEC block.After informed consent for surgery, anesthesia, and study participation, patients were escorted to the OR and assisted into a comfortable prone position. Full monitors were placed and 2 mg of IV Midazolam were administered. Each patient received an ultrasound-guided erector spinae plane (ESP) block to match their surgical region of interest. This emphasized a targeted approach, modified from the original work by Forero.After discharge, study participants were asked to differentiate, rate, and record their severity of surgical pain and muscle spasm every 6 hours for 48 hours using 2 separate numeric rating scales on a provided form Fig. . Pain anData were transcribed from the collection sheets into a Microsoft Excel spreadsheet, without any HIPAA identifiers and presented to a statistics specialist. After transcription, descriptive statistics were generated to characterize the centrality and dispersion of the data, and box plots were generated to depict pain and spasm scores over time.A total of 25 women aged 22–70 agreed to participate in data collection. In total, 17 of the 25 patients returned the spasm and pain tool at their first postoperative visit. The 48-hour postoperative scores for pain and spasm are depicted in Figures 1 These desirable elements can be accomplished without the need for parenteral muscle relaxants, negating the need for tracheal intubation in many patients and making opioid-free anesthesia more prolific for patients to experience, and easier for anesthesia providers to employ.One fairly unrecognized advantage of the INTRAPEC injection is muscle compliance during the surgical subpectoral implantation procedure. Following preprocedural INTRAPEC injection, the pectoralis major muscle itself remains pliable and compliant while being surgically manipulated. This is a valued asset in the surgical field during implant placement and sizing.We recognize that there are several faults to the study. Some patients have an inherent difficulty in differentiating pain from spasm despite a thorough explanation. This may account for the outlier data set. The data collection is entirely dependent on patients’ mindful and careful participation. We found that many patients returned incomplete records or failed to complete records altogether. This made the overall study population reduced. The primary study investigator was also responsible for performing all of the ultrasound-guided regional techniques. This could potentially introduce bias. The data collection tool asked patients to record their experiences every 6 hours, which, while reasonable, is not as precise as recording every hour. However, from a practical standpoint, asking patients to record values hourly seemed too cumbersome and would promote inaccuracies. Many implant recipients, despite good anesthesia and analgesia, complain of pressure that may be confused with either spasm or pain. Patients who had experienced extensive surgical times, requiring arm abduction, often complained of shoulder pain. The recording of this and other types of non-surgical pain that happened to coincide with pain gathering data, could also affect statistical outcomes.We also observed that the INTRAPEC technique seems to be effective in causing muscle compliance at relatively low concentrations of local anesthetic. Despite the association of higher concentration of local anesthetics usually needed to cause motor blockade through targeted nerve block techniques, injecting local anesthetic directly into the muscle itself was responsive to low concentrations.8 As the pain scores were not the primary outcome, we did not include their formal investigation in the Results section but made the causal observation that the patients who recorded low spasm scores also tended to record low pain scores over time. While the pain generators for incisional pain are supposedly covered with the ESP block, it is unlikely that the spasm control is affected by the ESP technique. We also recognize that some postmastectomy patients may have denervation caused by surgical damage. These patients may inherently record either higher scores caused by chronic pain or lower scores caused by nerve dysfunction. Additionally, due to its retrospective nature and simple design, the study was not weighted against a control group and would be less statistically relevant as a scientific effort.It is also recognized that spasm relief may also be tied to pain relief.Finally, to our knowledge, the INTRAPEC injection for pectoralis major spasm control remains the only technique allowing for effective intraoperative and postoperative isolated relief for this application of subpectoral implantation.The study results support the notion that the ultrasound-guided INTRAPEC injection, placed before the surgery, satisfactorily controls pectoralis muscle spasm for subpectoral implantation for cosmetic or restorative surgeries of the breast. We are hopeful that further studies will examine a more detailed investigation of the technique and find similar positive results.The authors would like to formally recognize Dr. Wayne Lee, MD, for his willingness to permit and support this effort. Special thanks is also extended to Racheal Brodsky, RN, for her assistance and diligence in encouraging patients to follow through with data production and relaying the data to the primary investigator.


Chronic pelvic pain (CPP) is defined as chronic pain and inflammation in the pelvic organs for more than six months. There are wide ranges of clinical presentations, including pelvic pain, painful intercourse, irritable bowel syndrome, and pain during urinating. Chronic pelvic pain syndrome (CPPS) is a subdivision of CPP, and the pain syndrome may be focused within a single organ or more than one pelvic organ. As there is uncertain pathogenesis, no standard treatment is currently available for CPPS. Botulinum toxin A (BoNT-A) is a potent neurotoxin that blocks acetylcholine release to paralyze muscles. Intravesical BoNT-A injection can reduce bladder pain in patients with interstitial cystitis/bladder pain syndrome. BoNT-A injected into the pelvic floor muscles of women has also been reported to improve chronic pain syndrome. Due to the reversible effect of BoNT-A, repeated injection appears to be necessary and effective in reducing symptoms. Adverse effects of BoNT-A may worsen the preexisting conditions, including constipation, stress urinary incontinence, and fecal incontinence. This review summarizes the evidence of BoNT-A treatment for CPPS in animal studies and clinical studies regarding the therapeutic effects of BoNT-A for CPPS in female patients. Chronic pelvic pain (CPP) is chronic or persistent pain perceived in pelvic structures for more than six months with continuous or recurrent pelvic pain as well as with symptoms suggestive of the lower urinary tract, sexual, bowel, pelvic floor or gynecological dysfunction in men and women . CPP mayCPPS is a subdivision of CPP and the pain syndrome may be focused within a single organ or more than one pelvic organ, including bladder, urethra, vagina, rectum, anus and whole pelvic musculatures . When thCPPS of women can exhibit different symptoms, including dyspareunia, dysmenorrhea, dyschezia, and non-menstrual pelvic pain. It may also cause lower urinary tract symptoms, such as frequency, urgency, difficulty urinating, and pain with urination. The most important evaluations for diagnosis of CPPS are medical history and physical examinations. . VaginalThere is no single definitive etiology or standard management for CPPS. It is supposed that CPPS results from a combination of risk factors, such as neurological, mechanical, and biochemical factors. More than one-half of CPP patients live with interstitial cystitis/painful bladder syndrome (IC/BPS), endometriosis, irritable bowel syndrome, or pelvic adhesions ,7. SpastThe European Association of Urology (EAU) proposed comprehensive guidelines about the diagnosis and management of CPPS . ManagemBotulinum neurotoxin (BoNT) comprises seven different serotypes (A to G) and more than 40 subtypes . These sBoNT-A injection can reduce spasms and pressure in the PFMs of women with CPPS . Many woClostridium botulinum was first isolated in 1895. BoNT-A was first purified from bacterium Clostridium botulinum in 1928 and its off-label use started in the 70s [Bacterium  the 70s .There are three major mechanisms of BoNT-A that function on the muscles, neural system, and inflammation to relieve pain symptoms . BoNT-A BoNT-A is a selective neurotoxin that acts on neuromusculatures. After binding to terminal receptors on the motor neuron, it can inhibit the release of ACh to cause muscle paralysis. BoNT-A inhibits ACh vesicles releasing to the synaptic cleft by cleaving particular proteins, such as SNAP-25 or VAMP, which are essential for binding with ACh vesicles at the presynaptic membrane. Due to the effect of BoNT-A, there is no release of ACh in the synaptic cleft, and it can paralyze the innervated muscles subsequently . This meAnimal studies reported that BoNT-A could inhibit the delivery of several neurotransmitters, such as calcitonin gene-related peptide (CGRP), glutamate, adenosine triphosphate (ATP), and substance P ,23,24,25BoNT-A may block these neurotransmitters from releasing muscular nociceptors, and reduce the symptom of muscle pain in patients with CPPS . BoNT-A In addition, BoNT-A has the analgesic effect of relieving pain symptoms. From the animal and human studies, increased expression of cell membranes receptors, such as the TRPV1 and P2 × 3, in the nociceptors may up-regulate the symptoms of neuralgia ,28. BoNTAfter the injection of BoNT-A, paralysis of muscle occurs after 2–5 days . The cliAfter formation of antibodies against BoNT-A, the duration of the BoNT-A effect and the therapeutic extent of the maximal treatment effect are usually reduced after a few BoNT-A applications  before complete therapy failure occurs .BoNT-A was first used for therapeutic purposes in the 1960s when Dr. Alan B. Scott, an ophthalmologist, injected BoNT-A into extraocular muscles of rhesus monkies to treat strabismus. His results were successfully replicated in humans . BoNT-A Although BoNT-A has been widely used for muscular disorders, its role in treating CPPS has yet to be established. Present literature suggests that injecting BoNT-A into the PFMs may improve symptoms in women with CPPS. Joo et al. reported a 50% success rate of BoNT-A injection in anismus for a long-term period . Brin anA systematic review including five studies supports that BoNT-A treatment was beneficial for relieving spasms of PFMs due to CPPS ,35. BoNTp = 0.005), and fewer trigger points . There was an improvement (20.7%) in patients with the previous placement of incontinence sling versus no improvement (0%) in pain (p = 0.003).CPP can occur at several muscles in the pelvic region such as pubococcygeus, ischiococcygeus, iliococcygeus, piriformis, transverse perinei muscles, and obturator internus. Preliminary studies have reported that BoNT-A injection could be able to decrease levator ani muscle spasms in women with CPP ,36,37. HThe major factor of pelvic pain in women with a spasm of PFMs appears to be ischemia due to vessel compression of the muscles, which leads to the release of bradykinin and sensitization or excitation of nociceptors . BoNT-A Because of the reversible effect and natural metabolism by the body, treatment with repeated BoNT-A injection for CPPS is frequently required. A low dosage of BoNT-A was injected in other muscle groups of the body at three-month intervals, as it was unlikely to produce significant side effects .Injection of 300 U of BoNT-A into PFMs may be safe, especially administered to the regions of hyper-spastic muscles [The etiology and pathophysiology of IC/BPS are still unclear. There are many treatments for relieving IC/BPS including analgesic medicine, changing habits of lifestyle, pentosan polysulfate sodium, cystoscopy with hydrodistention, or instillation of dimethyl sulfoxide in the bladder.Smith et al. first reported that submucosal BoNT-A injection into 20 to 30 sites of the trigone and bladder floor for a total of 100 to 200 U would result in a 69% improvement of IC/BPS patients, including daytime frequency episodes, nocturia, pain, and bladder capacity . In 2009In 2016, a multicenter, randomized, double-blind, placebo-controlled trial compared hydrodistention plus 100 U of BoNT-A injections at 20 sites with injections of normal saline at 20 sites in 60 patients with refractory IC/BPS. A significantly greater reduction of bladder pain symptoms and increased bladder capacity under cystoscopy were observed in the group with BoNT-A injection, with 63% of overall success rates versus 15% in the normal saline group .p = 0.0242) and three repeated injections (p = 0.050) [Compared to single intravesical BoNT-A injection for IC/BPS patients, there were long-term therapeutic effects in repeated injections, such as pain relief, improved bladder capacity, and better success rates for a long-term period. Kuo et al. reported a repeated intravesical injection of 100 U of BoNT-A every six months for up to four times or until symptoms improved in 81 patients with refractory IC/BPS. It showed significant improvement in pain relief, FBC, and daytime frequency after repeated therapy with different BoNT-A injections. Compared to one single injection, it also reported significantly better success rates for four repeated injections p = 0.02 and thre= 0.050) .Liu et al. reported the levels of nerve growth factor (NGF) in the bladder tissue were significantly increased in 19 patients with IC/BPS compared with 12 healthy patients. After injections with 100 U or 200 U of BoNT-A followed by cystoscopic hydrodistention two weeks later, they showed a decrease of the NGF mRNA levels and no significant difference compared with the healthy controls . IntraveThe injection sites and the numbers of injections are controversial. It has been reported to inject BoNT-A into the trigone and the posterior bladder wall simultaneously, only the trigone, and sites excluding out the trigone. Pinto et al. reported injecting 100 U of BoNT-A into ten trigonal sites compared to saline injections for refractory IC/BPS patients. They showed significant improvements in bladder pain and quality of life . Jiang eKuo et al. investigated the therapeutic predictors, such as ICSI, ICPI, FBC, frequency, and first desire to void for successful treatment of BoNT-A injection in the bladder for refractory IC/BPS patients. Successful treatment was defined as GRA ≥ 2 at six months. The success rate was 45.54% at six months. Multivariate logistic regression showed the only therapeutic predictor for successful management was the baseline ICSI. Patients with an ICSI ≥ 12 may indicate a poorer therapeutic outcome of BoNT-A injections . For refTo summarize, BoNT-A injection has been widely studied for IC/BPS patients and it has become a promising treatment for refractory IC/BPS patients with the combination with hydrodistention , althougAlthough there is currently no definite animal model for CPPS, several chemical-induced cystitis animal models have been used to investigate the pathophysiology and develop a new treatment strategy for this disease. Lucioni et al. explored the effect of BoNT-A on the sensory neurotransmitters in chronic and acute injury models of the rat bladder by intraperitoneal injection of cyclophosphamide (CYP) and incubation of the bladder preparation with hydrochloric acid (HCl). The study found that a greater release of neuropeptides substance P (SP) and CGRP caused by acute injury with HCl and suggested that there is a potential therapeutic effect of BoNT-A in the treatment of neurogenic inflammation of the bladder .Cayan et al. used 41 female Sprague-Dawley rats with intravesical instillation of HCl monthly to induce chemical cystitis and maintain chronic inflammation. These rats injected with 2-3 units of BoNT-A into the bladder detrusor and saline as the control group. Urodynamic studies showed that BoNT-A treatments increase the maximum bladder capacity and bladder compliance compared to the control group at the beginning and end of the study. The histological examinations reported similar counts of mast cells and leukocyte infiltration in these two groups. In this animal model of chemical cystitis, injected BoNT-A into the bladder detrusor led to improvements in vesical function which may be an alternative, minimally invasive treatment compared to other surgical modalities for a chronic inflammatory condition to improve deteriorated bladder function .Smith et al. demonstrated intraperitoneally injected 150 mg/kg CYP to induce chronic cystitis in female Sprague-Dawley rats. It showed an increase of voiding frequency and hyperactivity of bladder. Treatment with CYP or BoNT-A did not affect the release of ATP in resting urothelium. Injection of CYP led to hypoosmotic stimulation and an increase of ATP release in chronic cystitis. After BoNT-A treatment, hypoosmotic shock-induced ATP decreased significantly. Cystometry revealed that CYP injection increased non-voiding bladder contraction. BoNT-A instillation markedly reduced non-voiding contraction frequency that was induced by CYP injection. However, neither CYP nor BoNT-A nor a combination of CYP + BoNT-A had any effect on the contraction frequency of bladder voiding. Furthermore, intravesical instillation of BoNT-A did not affect the release of ATP from the serosal side, implying that its effects were confined to the urothelial side of the bladder preparation .Vemulakonda et al. studied the inhibitory function of BoNT-A on afferent pathways of chronic inflammation in the bladder. Among four groups of female Sprague-Dawley rats, namely group 1: saline-treated, group 2: BoNT-A treated, group 3: CYP treated, group 4: BoNT-A and CYP treated, all animals received intravesical protamine sulfate (1%), followed by intravesical BoNT-A or saline, and subsequently CYP or saline-injected intraperitoneally. Compared to saline controls, the study showed an increase of L6 and S1 c-fos immunoreactive cells after CYP treatment. BoNT-A/CYP treated group presented with a significant decrease of L6 and S1 c-fos immunoreactive cells compared with the CYP group. There was no significant difference in presentation between these two groups of saline and BoNT-A alone. Cystometrogram revealed that the increase of the non-voiding intercontractile interval in the BoNT-A/CYP group was more than 10-fold in CYP group. Conclusively, in a CYP animal model of chronic bladder inflammation, intravesical BoNT-A significantly inhibits the afferent neural response without impairing efferent bladder function . Table 3p = 0.011) and 24  than baseline (7.8). The Female Sexual Distress Scale (FSDS) showed significant improvement of sexual function at 8 weeks , 12 weeks , and 24 weeks  compared with baseline (34.5). Resting pressures and maximum contraction pressures of the vagina as measured by vaginal manometry significantly decreased during all follow-up examinations (p < 0.05).Women with sexual pain disorders experience genital pain during sexual intercourse occurring at the periods including before, in the process, or after the sexual activity that involves the clitoris, vulva, vagina, and/or perineum, thus causing difficulty in sexual intercourse and personal distress. Dyspareunia is painful sexual intercourse, in which pain can occur over the external genitalia, inside the vagina or deeper pelvis due to numerous medical, physical, social, or psychological causes. Generally, the prevalence of dyspareunia was reported to affect between 8%–21.1% of women . More seVulvodynia is characterized as genital pain without clear etiology that may have resulted from sexual intercourse and causes sexual pain disorder. In the general population, the estimated prevalence of vulvodynia ranges from 10% to 28% in reproductive-aged women . Aberranp < 0.01), Negative Interference in Quality of Life (NIQL)  and the cotton swab test .Hedebo et al. used BoNT-A to treat vulvodynia refractory to conventional treatment for at least six months . The cohHigh doses of BoNT-A injection seem to have effectiveness in the treatment of vulvodynia related to sexual pain syndrome. A randomized, double-blind, three-arm, placebo-controlled study from June 2008 to September 2014 included 32 women aged 23–35 years with provoked vestibulodynia . They sup < 0.0001). Eighteen women (95%) were able to have sexual intercourse after 24 months.In 2016 Pelletier et al. evaluated in a prospective cohort study the long-term effectiveness of BoNT-A injection for more than two years in 19 women with provoked vestibulodynia . Fifty uBoNT-A was successfully used in sexual pain syndrome and appeared to have long-term beneficial effects for sexual activity . It is iThe common adverse events of BoNT-A injection into the bladder for IC/BPS are slow urinary flow rate, decreased detrusor pressure, and dysuria ,62,63.The most common adverse event of BoNT-A injection into PFMs for CPPS is dysuria. Increasing flatus has also been reported after BoNT-A injection into bilateral puborectalis and pubococcygeus muscles in women with chronic pelvic floor muscle spasms .Adelowo et al. reported several adverse events, including retention of urine, fecal incontinence, constipation, and rectal pain after BoNT-A injection into PFMs , which would be resolved spontaneously . This miSince the urethral sphincter and anal sphincter are adjacent to PFMs, BoNT-A injected into PFMs may result in disruption of urethral and/or anal sphincter mechanisms . The advDressler et al. reported atrophy of target muscles after repeated injections of BoNT-A into a hyperactive muscle . HoweverAlthough most of the adverse events resulting from BoNT-A treatment are usually self-repairing, it should be clearly explained to the patient before BoNT-A injection. It is important to discuss with the patient the possibility of mild, transient, and reversible adverse effects on musculatures before BoNT-A injection.There is still no guidelines about single injections or repeat injections, frequencies of repeat injections, an acceptable interval during repeat injections, injected sites and numbers, and maximum dosage of BoNT-A.It is challenging to treat female CPPS patients because of the uncertainty of this disorder. There is currently no definite animal model for CPPS, although the chemical-induced cystitis rat model has been used to investigate the treatment strategy for this disease. Combination management, including physical therapy, biofeedback, behavioral modifications, and medicines may improve CPPS in women. Current literature suggests BoNT-A injection provides promising results in relieving symptoms of pelvic floor pain and muscle spasms in female patients. Intravesical injection of BoNT-A plus hydrodistension also helps to improve symptoms in refractory IC/BPS patients. BoNT-A injection appeared to have long-term beneficial effects for sexual activity in patients with sexual pain syndrome. It is safe for BoNT-A injection with limited adverse effects. However, more double-blind, randomized, controlled clinical studies and well-designed animal studies are needed to support the beneficial efficacy of BoNT-A injection in female patients with CPPS.


Two independent reviewers screened titles/abstracts of 327 studies and 46 full-text manuscripts. In total, 16 articles were eligible for inclusion; 15 reported effectiveness outcomes and 11 presented safety outcomes. Follow-up duration ranged from 6–34 months. Mean pain relief was >50% in most studies, regardless of follow-up duration. Responder rates ranged from 67–100% at ≤12 months follow-up, and from 46–76% thereafter. 32–71% of patients decreased opioid or nonopioid analgesia intake. Complication incidence rates were consistent with other published SCS literature. Findings suggest 10 kHz SCS provides safe and durable pain relief in pragmatic populations of chronic pain patients. Furthermore, it may decrease opioid requirements, highlighting the key role 10 kHz SCS can play in the medium-term management of chronic pain.10 kHz spinal cord stimulation (SCS) is increasingly utilized globally to treat chronic pain syndromes. Real-world evidence complementing randomized controlled trials supporting its use, has accumulated over the last decade. This systematic review aims to summarize the retrospective literature with reference to the efficacy and safety of 10 kHz SCS. We performed a systematic literature search of PubMed between 1 January 2009 and 21 August 2020 for English-language retrospective studies of ≥3 human subjects implanted with a Senza Chronic pain is reported to affect around 20% of adults ,2 and isFor nearly a decade, 10 kHz spinal cord stimulation (SCS) has been used to treat chronic pain syndromes of various etiologies. This minimally invasive therapy delivers high-frequency electrical pulses to the spinal cord without producing paresthesia . A high It is accepted that robustly designed RCTs are the reference standard for evaluating the causal relationships between a treatment and an outcome of interest (as far as this is possible) whilst minimizing bias. Controlling for patient selection and implementing rigorous clinical protocols in an RCT evaluates treatment outcomes in ideal circumstances but may not be a true reflection of how the treatment will work in a non-trial setting ,38,39,40Currently, a comprehensive overview of reported clinical experience, including both effectiveness and safety outcomes, is lacking. Considering the importance of real-world evidence in clinical decision making, there is an unmet need for a literature review specifically summarizing retrospective real-world studies from clinical practice. Therefore, to gain more insight into the clinical benefits and safety profile of 10 kHz SCS in real-world conditions, we performed a systematic review of all available retrospective studies.® 10 kHz SCS system received its first regulatory approval in 2010 , the literature was searched from 1 January 2009. The search was executed on 21 August 2020.The literature search was conducted using the National Library of Medicine PubMed electronic database. Combinations of relevant keywords were used, including spinal cord stimulation, 10 kHz, HF10, high-frequency, and kilohertz frequency. Since the Senza® 10 kHz SCS system. The minimum follow-up period was 3 months to exclude studies focused on temporary trial or very short-term outcomes. Peripheral nerve stimulation applications were excluded. Only English-language articles published in peer-reviewed journals were considered.Studies were included if the clinical outcome or safety data were collected retrospectively from at least three human subjects implanted with a SenzaTwo reviewers worked independently to screen titles and abstracts for original studies that met the eligibility criteria (with full-text manuscripts consulted for verification if necessary). Disagreements were resolved by consensus. Full-text manuscripts were obtained for all studies determined to be eligible.Data were extracted from all eligible studies by the principal reviewer, tabulated in a Microsoft Excel spreadsheet, and crosschecked by the second reviewer. Study design variables were documented, along with the primary outcomes of interest, including average pain relief of the cohort versus baseline, the group responder rate (with response defined as ≥50% pain relief from baseline), medication change, functional capacity and quality of life (QoL) outcomes, and the incidence and sequelae of complications. The heterogeneity of patient populations in the studies precluded traditional meta-analytic approaches. Instead, we provide a narrative synthesis of study key features and the principal outcomes of interest.A total of 373 unique articles were identified from the initial PubMed query: 327 articles were screened by title and/or abstract only, and 46 articles were screened by full-text manuscript review see . In totaIn 12 studies that reported effectiveness outcomes, the majority of patients had 10 kHz SCS leads placed in the thoracic region, usually to treat pain distributed in their back and/or leg(s). Stauss et al. (2019) conducted the largest study, including 1660 trunk and/or limb pain patients from eight centers in three countries , while SIn Stauss and colleagues’ study, 84% of trialed and/or implanted patients (1370/1640) had chronic back and leg pain . Final fp < 0.001; N = 125). Disability among those with available data was also noted to improve by 8.6 points on the Oswestry Disability Index . In a subgroup of 38 patients who had previously undergone failed traditional LF-SCS and/or peripheral nerve field stimulation (PNFS), mean pain reduction was similar to the full cohort at the 6-month assessment . The authors also reported ≥50% pain relief in 55% of this subgroup.In a smaller, multicenter, Australian study by Russo et al. (2016), the majority of included patients (N = 256) also had back and/or leg pain , with leads typically placed from vertebral levels T8 to T11 . In totap < 0.001), and disability score improved on the ODI by 13.8 points .In another Australian study, Finch et al. (2018) performed an audit of 58 patients treated in their clinic with 10 kHz SCS up to 12 months after implantation . The majp < 0.001; N = 30) and a similar mean reduction in leg pain . In total, 71% of patients (15/21) decreased their opioid dosage during the follow-up period, with an average reduction of 28% . Disability score also improved by an average of 3.1 points over the 12 months among those who completed the modified Roland Morris Disability Questionnaire .Another single-center study conducted in a community-based pain facility by DiBenedetto et al. (2018) evaluated 12-month outcomes in 32 patients treated with 10 kHz SCS for back pain with or without leg pain . The invp = 0.004). At their last follow-up, response to therapy was observed in 89% of patients (17/19), and 47% (9/19) decreased their medication intake. In total, 84% (16/19) and 74% (14/19) of the cohort also indicated general improvements in function and sleep, respectively.The efficacy of 10 kHz SCS in patients with thoracic back pain was analyzed in a multicenter study by Sayed et al. (2020) . All 19 Gill et al. (2019) evaluated 10 kHz SCS outcomes in 12 implanted patients from their clinic with complex regional pain syndrome (CRPS) . PatientSchieferdecker et al. (2019) noticed that 10 kHz SCS therapy positively affected bladder incontinence in some of their patients. The authors reviewed data from five trunk and/or limb pain patients in their clinic treated with 10 kHz SCS who also had neurogenic bladder dysfunction secondary to either spinal injury during surgery (n = 4) or demyelinating neurological disease (n = 1) . ActivatHigh-frequency 10 kHz SCS has also been reported by Simopoulos et al. (2018) to improve neuropathic pelvic pain in a small case series from their clinic comprising three patients . Individp < 0.0001; N = 72) and 53% , respectively. Corresponding responder rates were 56% (40/72) and 59% (34/58). The majority of the cohort  also indicated they were moderately to a great deal better on the Patient Global Impression of Change (PGIC) questionnaire.Al-Kaisy et al. (2020) exclusively focused on patients with back pain with or without leg pain in their single-center study that examined the effects of 10 kHz SCS delivered via sequentially activated adjacent bipoles (cascade programming) covering vertebral levels T8-T10 in 99 implanted patients . In totap < 0.0001; N = 13), with FBSS and CRPS patients experiencing 60%  and 52%  mean pain relief, respectively. Corresponding responder rates for all, FBSS, and CRPS patients were 46% (13/28), 35% (6/17), and 67% (6/9), respectively. Among FBSS patients, average disability score on the ODI decreased by 19.7 points  during the follow-up period, and 44% reduced their ODI disability category from severe and/or bedbound to minimal and/or moderate.While three of the studies described above analyzed 10 kHz SCS outcomes in subgroups of patients with previously failed traditional LF-SCS ,55,59, GSills (2020) reported the outcomes of lower body polyneuropathic pain treated with 10 kHz SCS at his center . ClinicaThree studies reported effectiveness outcomes in patient populations in which the majority had 10 kHz SCS leads placed in the cervical region. Of these, two studies evaluated effectiveness in neck and/or upper limb pain patients ,50. The p < 0.01) and 77% (p < 0.05) decline in neck pain and upper limb pain on the VAS, respectively. Average functional capacity measured on the ODI and Global Assessment of Function (GAF) scales also improved, with a mean decrease of 11.2 points and median interval increase from 50–41% to 70–61%, respectively. Among the 23 patients who took opioids at baseline, total daily opioid dosage decreased from 1020 mg/day to 450 mg/day at 12 months, a reduction of 56%. Among the 10 patients who took nonsteroidal anti-inflammatory drugs (NSAIDs) at baseline, the total daily dosage decreased from 6750 mg/day to 1425 mg/day at 12 months, a reduction of 79%.In the first neck and/or upper limb pain study by El Majdoub et al. (2019), 24 patients from their clinic were trialed with 10 kHz SCS via a single cervical lead with the tip located at the C2 vertebral level . Of the p < 0.050), and 73% (8/11) achieved response to therapy. During the follow-up period, the authors also noted an average improvement of 101% in QoL score among the cohort, measured using the EuroQol-5D (EQ-5D) time trade-off valuation, as well as a 79% reduction in catastrophic thinking related to pain . The average intensity and impact of pain also improved by 49% (N = 10) on the Brief Pain Inventory (BPI).Al-Kaisy et al. (2015) investigated 10 kHz SCS for neuropathic limb pain in a single-center evaluation . The majIn the second of the studies examining outcomes in neck and/or upper limb pain, Sayed et al. (2020) reviewed multicenter data from 47 patients at a median follow-up of 19.4 ± 12.4 months . Leads wp = 0.00001). The author also noted 63%, 60%, and 59% reductions in head and neck pain, upper back pain, and lower back pain, respectively. Furthermore, opioid consumption decreased by 40% within the group of 15 patients who remained on opioids at the last follow-up (down from 24 patients at baseline). Among those on high dose opiates (N = 11), opioid intake declined by 47%. Among the main study population, functional improvement was observed on the RMDQ . Both the pain self-efficacy (PSEQ) and anxiety and depression (DASS) instruments also indicated psychometric benefits, with an average increase in PSEQ score of 13 points (N = 29), and fewer patients categorized as moderately severe or severe on the DASS compared with baseline . The majority  of patients indicated they were moderately to a great deal better on the PGIC questionnaire. Notably, the proportion of work-eligible patients in employment more than doubled compared with baseline (20/31 vs. 8/31).Combined cervical and thoracic lead placement  was evaluated in only one study. Salmon (2019) evaluated 10 kHz SCS in a population of 38 patients from his clinic with widespread neuropathic/nociplastic pain, followed for a mean of 2.3 ± 1.7 years . Among tSafety data were reported in 11 studies and are summarized in The incidence of infection, including during the trial period, ranged from 0% to 13% in six studies ,52,59,60Pain over the site of the implantable pulse generator (IPG) occurred at a rate of 0% to 27.3% in six studies ,53,59,60The incidence of insufficient pain relief ranged from 0% to 15.8% in four studies ,52,53,59Lead fracture or high impedance incidence rates were 0% and 2.6% in two studies that examined safety outcomes in a total of 50 patients ,53. The Importantly, neurological deficit was not reported by any study, while one study documented increased sensation in several patients with painful polyneuropathy, indicating neurological improvement .In the first of two multinational studies that detailed 10 kHz SCS explant rates, Stauss et al. (2019) reported 48 explants among 1290 patients, an incidence rate of 3.7% . Of thesSeveral literature reviews of 10 kHz SCS therapy have summarized treatment effectiveness. However, these reviews were not conducted systematically and did not examine safety outcomes in detail ,42,43,44The evidence identified during our literature search included 16 studies in total, encompassing 2382 patients implanted with a 10 kHz SCS system. Follow-up ranged from 6–34 months. The patient populations mainly had pain located in their back and/or legs, neck and/or upper limbs, or purely in their upper or lower extremities. Leads were generally placed at the T8-T12 vertebral levels to treat pain in the back and/or legs, while pain in the neck and/or upper limbs was usually treated via C2-C7 lead placement. All but one of the 15 studies that included effectiveness outcomes reported either average pain relief or responder rate . Studies that reported safety outcomes (11/16) identified complications associated with the therapy, sequelae, and the number of patients affected. Nine studies provided information on medication use, nine detailed changes in functional capacity, and eight presented QoL data. Notably, more than two-thirds of the studies were published within the last 2 years, and a third within the last 6–7 months, showing the rapid emergence of new evidence in this field.At ≤12 months of follow-up, average pain relief across the studies (not including subgroups) ranged from 46–77% ,57,59,60Overall, our synthesis of the retrospective evidence on 10 kHz SCS found that pain relief was sustained at long-term follow-up, and a significant proportion of patients were able to reduce their opioid or medication requirements. The combination of durable pain relief and opioid reduction associated with 10 kHz SCS is an important consideration given the questionable benefit and risks attendant with long-term opioid use in chronic pain patients. In addition, most studies in our review also reported improved functional capacity and/or QoL. This has the potential to reduce health care costs among this often highly disabled group of patients. Moreover, studies in our review that examined subgroups of patients with a history of failed traditional LF-SCS found similar pain relief outcomes to patients who were SCS-naïve, suggesting that 10 kHz SCS may be a useful salvage therapy in this difficult-to-treat cohort. Ultimately an SCS national/global registry with 100% compliance would more accurately capture the long-term safety and efficacy of these devices.The most common complication associated with 10 kHz SCS among the studies that provided safety data was IPG site pain with a mean incidence across studies of 10.4%, followed by lead migration (6.2%), insufficient pain relief (5.1%), infection (4.0%), and lead fracture (1.3%). The incidence rates of these complications are consistent with the published SCS literature  61,62,6,65,66,67This review provides a systematic and comprehensive overview of the effectiveness and safety data from all 10 kHz SCS retrospective studies. The included research was conducted in multiple countries and institutions, and included pragmatic chronic pain populations. Follow-up duration in several studies exceeded that of the longest duration RCT and formal prospective studies of 10 kHz SCS in selected populations carried out to date. Finally, since more than half of the studies were published within the last 2 years, and a third were published within the last 6–7 months, this review captures the most recent therapy outcomes in a rapidly evolving area of evidence.There are some limitations to this review. The included studies were retrospective in design and were therefore limited by potential selection biases as well as the availability and accuracy of recorded data. In addition, most studies were conducted in one or two centers, follow-up was not uniform, outcomes were not reported longitudinally, remission data were absent, and sample sizes were small in around half of the studies. Furthermore, the reporting of medication, functional capacity, QoL, and safety data were inconsistent across studies and not at a granular level. Meaningful categorization of the studies in terms of the chronic pain diagnosis was also challenging due to the heterogeneity of the patient populations, for example, the wide range of pain distribution . Therefore, a meta-analysis was not considered appropriate. The limitations of retrospective studies generally should be considered during interpretation of the results.The application of high-frequency spinal cord stimulation in the management of chronic pain is rapidly evolving, with multiple studies published very recently evaluating the 10 kHz SCS modality. This systematic review and narrative synthesis provides a comprehensive and up-to-date overview of all retrospective real-world studies to aid clinical decision making in routine practice. Our results suggest that 10 kHz SCS provides durable pain relief and can facilitate a reduction in the use of pain-relieving medication (including opioids). Furthermore, the therapy appears to be associated with improved functional capacity and quality of life. 10 kHz SCS has a safety profile comparable to current and historical devices.


Low back pain is a chronic recurrent symptom, which can lower the patient's quality of life. With technological development of automated home massage systems, now offers a promising alternative to physiotherapy. However, thus far, the effectiveness of such methods has not been evaluated. We aimed to compare the efficacy and cost-effectiveness of a massage chair with those of conventional physiotherapy for the treatment.This was a randomized controlled trial with a two-group parallel design. Following randomization and allocation, 56 participants were enrolled to receive either physiotherapy (n = 25) or mechanical massage using the massage chair (n = 31). Pain severity was measured using a visual analog scale (VAS) and satisfaction assessed with the McGill Pain Questionnaire (MPQ). Quality of life modification was analyzed using the Functional Rating Index (FRI). Cost-effectiveness was analyzed by comparing the sum of physiotherapy fees and monthly rental fees for chair massage.P < .001), satisfaction as assessed by MPQ (P < .001) and life quality improvement as assessed by FRI (P < .001) in both groups. Both VAS and FRI scores were significantly higher for physiotherapy than for massage chair . There was no significant difference in MPQ between the two groups. Massage chair therapy was more cost-effective than physiotherapy, at only 60.17% of the physiotherapy cost (P < .001).Physiotherapy and massage chair were both effective for pain control as assessed with the VAS (The home massage chair system was cost-effective, but pain control and disability improved more with physiotherapy. However, our results showed that the massage chair is a promising treatment for pain control and quality of life modification, but efficacy is still superior in physiotherapy and the chair is not a replacement for physiotherapy.Clinical Research Information Service, KCT0003157. Retrospectively registered August 2, 2018. Treatment for LBP involves clinic-based physiotherapy which includes high thermal muscle relaxation, muscle stimulation, and ultrasound-based relaxation, all of which have demonstrated efficacy for pain control.,8 Currently, symptomatic treatment, including various exercise and massage therapies, is a promising treatment strategy to relieve pain. However, there is insufficient evidence to support the efficacies of these alternative therapies. Relaxation massage and movement education, which can be beneficial to individuals who have back pain, have been thoroughly investigated. However, only the effectiveness and safety of vibration therapy have been assessed through observational studies.,11 Thus far, the safety and effectiveness of multifunctional chair systems with heating, stretching, and relaxation functions have not been assessed. Furthermore, while such mechanical massage may reduce medical costs and increase accessibility of treatment, its cost-effectiveness has not yet been assessed. The purpose of the present study was to compare clinical outcomes such as pain control, satisfaction, and quality of life modification, as well as the cost-effectiveness of massage chair therapy with those of in-hospital physiotherapy.Lower back pain (LBP) is one of the common causes of disability and inability to work, and almost 70% to 75% of the population experience one attack of pain during their lives.22.1t test using G-power for Windows . Participants were recruited from an outpatient clinic and randomly assigned to one of two groups, either physiotherapy or mechanical massage chair therapy, using a confidential computer program . Written informed consent was obtained from all patients before starting therapeutic intervention.This was a prospective designed randomized controlled trial, and the evaluator was blinded. This study was approved by our institutional review board (Himchan-IRB 112294-01-201710-01) and is registered with the Clinical Research Information Service . We employed a two-group parallel design and calculated the required sample size for a comparative study using a two-sided 2.2The study was conducted at Himchan Hospital, Busan, Korea. Participants were spine center outpatient clinic LBP patients between December 2017 and March 2018 and were enrolled and randomly assigned to treatment conditions. Inclusion criteria were as follows:1)age 20 to 65 years,2)2, andbody mass index (BMI) between 17 and 30kg/m3)no history of spine surgery.A total of 61 patients with back pain were recruited after three weeks of advertising targeted to outpatients. Patients were excluded if they had pain radiating from the leg, cognitive impairment affecting the survey, recent vertebral fractures, serious comorbid underlying diseases, medication including non-steroidal anti-inflammatory drugs (NSAIDs), or evidence of progressive neurologic deficits. The evaluation was restricted to participants who completed the 3-week follow-up questionnaire and had been randomized to receive either massage chair therapy or physiotherapy. Finally, 31 (55.36%) participants were allocated to receive physiotherapy, and 25 (44.64%) were allocated to receive massage chair therapy.2.3In each group, patients received up to 6 treatment sessions within 3 weeks. These were conducted by 9 accredited physiotherapists, each with a minimum experience of 2 years, and the intervention methods for LBP were authorized by the Korean Physiotherapy Association.The massage chair therapy protocol was developed by three doctors employed by the manufacturer who developed the device . Total massage time was 20 min, including 3 min of constant stretching, 5 min of vibration mode and stroke mode, and 40-degree heating of the treatment region. This protocol is called the “back strengthen mode” and is one of the machine's most commonly used programs.The outpatient physiotherapy program was comprised of 5 min of ultrasound massage, 5 min of transcutaneous electrical nerve stimulation (TENS), 5 min of interferential current therapy, and 5 min of hot pack application. This approach is commonly used in patients for LBP.2.4 and detailed characteristics of pain, including location, nature, and the patients’ satisfaction were assessed using the short-term McGill Pain Questionnaire (MPQ). Quality of life modification was assessed using the Functional Rating Index (FRI). Prior to the application of both therapies, as well as at 1, 2, and 3 weeks after the initiation of therapies all of the above-mentioned parameters were recorded. Following the collection of all data, patients were asked their opinions about the overall outcomes of their treatment. The cost of physiotherapy was calculated as the sum of the cost that was covered under the national health insurance system and the cost borne by the patient. The massage chair therapy cost was derived from the monthly rental fee charged by Bodyfriend.Before randomization and group allocation, baseline characteristics such as age, height, body weight, BMI, vital signs, and history were recorded for all subjects. Subjective pain intensity was evaluated using the visual analog scale (VAS)2.5 Patients were instructed to indicate the severity of their pain on a scale bar between “0” (no pain) and “10” (the most extreme pain experienced ever). We used a scale bar that was specifically designed for back pain evaluation. The advantages of this method are that it is statistically sensitive and can be applied to either individuals or a small group.The first measures are the VAS score and frequency of pain. The MPQ is a self-reporting questionnaire. It comprises three main question types regarding pain: sensation, emotion, and subjective pain. It selects the most appropriate word for each of the 20 questions presented and evaluates the severity of the pain on a scale of 1 to 5. It provides quantitative information about the degree of treatment and distinguishes pain reduction with greater sensitivity than other methods.The second measure is the result of the MPQ score. The FRI measures quality of life, back pain, and radiating pain intensity on a scale of 0 to 10. Quality of life includes 8 parameters, sleeping, washing, traveling, lifting, working, performing hobbies, walking, and standing. In addition, the pain intensity and frequency are evaluated. Of a total of five points, “The scoring method is calculated as  ∗ 100 and converted from 0 to 100, and a higher score means that the pain is severe, and physical functional capacity is compromised.The third measure is the FRI score.2.6t test. Pre- and post-treatment VAS scores, MPQ results, FRI results and cost were compared using a two-sided Student's t test and the outcomes of each method were assessed via a paired t test and or Wilcoxon signed-rank test, as appropriate. All statistical analyses were performed using SPSS for Windows . Statistical significance was set at a P-value of <.05.Data are indicated as mean and standard deviation . Differences in baseline information between groups were compared using an independent 33.1P = .42). There were no significant differences between the two treatment groups in terms of gender (P = .22). The duration of pain was 10.52 ± 12.93 months in the physiotherapy group and 9.90 ± 10.15 months in the massage treatment group; the difference was not significant (P = .76).Baseline information for patients is presented in Table 3.2P < .001 in both cases). When comparing pain differences in each group on the MPQ scale, there was significant pain reduction in both the physical therapy and massage chair groups (P < .001 in both cases). In terms of quality of life modification assessed using the FRI, both physiotherapy and massage chair were effective (P < .001 in both cases). No complications or aggravation of pain following treatment were reported.Clinical outcomes, including the degree of pain reduction and quality of life modification for each group, are presented in Table 3.3P = .03, Fig. P = .27, Fig. P = .03, Fig. The comparison of outcomes between the two groups is shown in Table 3.4P < .001, Table The total cost of physiotherapy was determined as the amount set by the national health insurance. The patients were charged 4.03 United States Dollars (USD) per physical treatment and 9.79 USD for health insurance; thus, the total cost of therapy was 166.82 USD per month  may be developed for pain control. This may become a more patient-friendly method, as the machine might then converse and play music via artificial intelligence for people who do not prefer to sit alone in the mechanical massage chair. This would help to overcome the limitation of machines and would add to their existing benefits, such as easy accessibility and relatively low cost.Our study is novel in that it is the first to make use of a prospective design and randomized control to compare the effectiveness of mechanical chair massage with conventional treatment. There were some limitations in our study. First, there is limited scope for generalization due to the small number of study participants and short follow-up duration. Although no complications were reported, our results should be interpreted with caution. Further studies with a multicenter trial design are needed to compare the efficacies of these two treatment modalities in a larger group of participants. Second, we did not identify the origin of pain in our study participants. However, our study design was prospective and strictly controlled. In addition, we used multiple clinical scales, which support the clinical significance of our findings. Also, this study has value in that it is the first trial of comparison between in-hospital management and mechanical chair treatment. In future studies, diagnosis using radiologic and clinical examinations should be performed before treatment. Despite these limitations, we are the first to attempt this trial and thereby demonstrate that mechanical massage therapy may have a therapeutic advantage in the treatment of LBP; large-scale, multicenter randomized controlled trials may corroborate the results of the present study.5The results of the present study suggest that physiotherapy remains superior for pain control and overall satisfaction relative to the massage chair; nonetheless, the massage chair is effective for pain control and patient satisfaction. Furthermore, satisfaction following treatment was not inferior while cost-effectiveness was superior after conventional physiotherapy. With technological development, mechanical systems may eventually provide promising treatment and large-scale studies have to be designed for continuous evaluation of this technology.Conceptualization: Seung-kook Kim.Data curation: Seung-kook Kim, Aran Min.Formal analysis: Aran Min, Chuljin Jeon.Methodology: Taeyun Kim.Supervision: Choon-Key Lee MD.Visualization: Su-Chan Lee MD.Writing – review & editing: Soohyun Cho.