The objective of this study is to compare the safety and effectiveness of the temporary spinal cord stimulation (SCS) versus pulsed radiofrequency (PRF) in treating postherpetic neuralgia (PHN).  From September 1, 2019, to May 30, 2020, 44 PHN patients admitted to the Pain Department of the Foshan First People's Hospital, China were enrolled in this study. The patients were randomly assigned to SCS and PRF groups in a ratio of 1 : 1 and were given respective therapy for 8 days. Rash, in all patients, was located in the trunk and extremities of the spinal nerve (C4-L5), and the pain intensity was greater than or equal to 7 points on the VAS scale. Subsequently, we evaluated the visual analogue scale (VAS), efficiency rate (ER), complete remission rate (CRR), daily sleep interference score (SIS), patient health questionnaire (PHQ-9), generalized anxiety disorder assessment (GAD-7), bodily pain (BP), and physical function (PF) sections of the 36-item short-form health survey (SF-36) at the following time points: presurgery, as well as 1 week, 1 month, 3 months, and 6 months postsurgery. n = 20 SCS cohort, and n = 20 PRF cohort). Both cohorts exhibited comparable baseline values (P > 0 : 05). Particularly, they were similar in age, sex, pain duration, involved dermatome, and comorbidity. Among the variables that demonstrated marked improvements from presurgical data to 1 week postsurgery were VAS, ER, CRR, SIS, PHQ-9, GAD-7, as well as BP and PF of the SF-36 in both cohorts. In addition, this improvement persisted for 6 months. There was no complication related to surgery in any of our patients.  The final analysis was performed on 40 patients . Postherpetic neuralgia (PHN) is the leading and intractable complication of herpes zoster (HZ) –3. The pThe major treatment options for PHN therapy according to the European Federation of Neurological Societies are pharmacological and invasive intervention-based approaches –9. The iRadiofrequency is a minimally invasive, target-specific procedure that effectively reduces various types of persistent pain and has been used for PHN-related pain relief –13. HoweWe conducted this prospective RCT from September 1, 2019, till May 30, 2020, to evaluate the safety and efficiency of SCS versus PRF in treating PHN. The study was approved by the ethical committee of the Foshan First People's Hospital, China and was registered with the Chinese Clinical Trial Registry (registration number: ChiCTR2100050647). All the procedures during this study were followed according to the guidelines of the Declaration of Helsinki. A total of 50 patients were screened based on our inclusion and exclusion criteria, and 44 patients were enrolled in the study. Patients' inclusion and exclusion were based on the criteria mentioned in n = 20 and PRF, n = 20) as shown in In total, 50 patients were screened patients, and 6 patients were not allowed to participate in this study either due to inclusion/exclusive criteria (3 patients) or lack of providing consent to participate in this research (3 patients). A blinded statistician generated a random sequence, using an arbitrary number generator, and placed the numbers in numbered sealed and opaque envelopes. A nurse then used these envelopes to separate the remaining 44 patients into two cohorts, namely, SCS and PRF cohorts, in a 1 : 1 ratio. Before enrollment, all patients provided written informed consent. At the 6 month follow-up, 4 patients did not undergo the assigned treatments because 1 patient developed pneumothorax complication, 1 patient removed the electrode, and 2 patients did not participate in the follow-up. Thus, the study's final analysis only included 40 patients  was used in the SCS procedure while the Cosman G4  and radiofrequency needle  were used in the PRF procedure.Stimulus electrode and electric pulse generator (12) were monitored; and wide-awake local anesthesia was used.Patients undergoing SCS or PRF procedures were admitted for preoperative examination . The patThe SCS procedure for all patients in the SCS group was carried out. Briefly, the patient was placed in a prone position. The puncture point, located in the intervertebral space, was disinfected and an aseptic scarf was laid out. Once the lidocaine local anesthesia took effect, a tunnel needle was held at an angle of about 30° to the skin, and then, it slowly penetrated the epidural cavity. Subsequently, the needle core was pulled out, and an 8-contact electrode was placed via digital subtraction angiography (DSA). The electrode position was then adjusted in the epidural cavity slightly to the left or right as needed, prior to the activation of the test mode. The parameters for voltage, frequency, and pulse width were adjusted as 2V, 40 Hz, and 210 us, respectively. Finally, the skin incision was sutured and fixed with a sterile gauze dressing, followed by hospitalization for 7 days after SCS treatment. The SCS procedure was completed in the DSA room, and the relevant images are presented in For the PRF procedure, the puncture point was located at the inferior border of the cervical/thoracic/lumbar pedicle left/right anterior oblique position of DAS, and it was the lower margin of the upper vertebral body and the upper articular process of the corresponding segment. The shortest radiofrequency needle was inserted, and upon reaching the target point, a curved radiofrequency needle was introduced, along with the cannula, to enter the cervical/thoracic/lumbar superior articular process. The radiofrequency needle was then rotated inward into the intervertebral foramen. The needle tip depth was determined via positive and lateral fluoroscopy, and it was connected to the radio frequency machine. Subsequently, a sensory 50 HZ test was employed, where a voltage of 0.2 MV caused the patient's innervation area stimulated. The sensation of the original pain area was replicated with an exercise 2 HZ test, and the pulsed radio frequency mode was turned on. The radiofrequency needle was removed at the end of the procedure, and the wound was bandaged under mild pressure after 42° for 120 seconds and two cycles. The relevant images are presented in We analyzed patient profiles, such as gender, age, pain duration, dermatome involved, comorbidity, and baseline information of patients at the time of admission. Moreover, we also recorded additional presurgical baseline data, such as visual analogue scale (VAS), daily sleep interference score (SIS), patient health questionnaire (PHQ-9), generalized anxiety disorder evaluation (GAD-7), bodily pain (BP), physical function (PF) of the 36-item short-form health survey (SF-36), effective rate , and complete remissions rate . The major outcome was postoperative VAS, and secondary outcomes were SIS, PHQ-9, GAD-7, PF of SF-36, BP of SF-36 which were tested again at 1 week, 1 month, 3 months, and 6 months postsurgery.For VAS pain assessment, a 10 cm line represented from 0-10 was used wherein, the ends 0 denoted no pain, and 10 denoted severe pain. Patients were requested to pick a point on the line that best described their degree of pain . The daiα of 0.05 was set, and the test efficacy was 80%. The PRF cohort was set in a 1 : 1 ratio with the SCS cohort, and the sample population was predicted by the PASS 11.0 software , using a completely randomized design for the comparison of two samples' means. Based on the subsequent result, we required 18 samples per cohort, for a total of 36 cases. We considered an expected 20% loss to follow-up; therefore, 8 additional cases were proposed for this study; thus, providing a total sample size of 44 cases, with 22 in the PRF cohort and 22 in the SCS cohort.The main observation in this study was the degree of postoperative VAS pain reduction, and the overall sample size was estimated, based on the postoperative VAS. According to the pretest results of 14 samples, the mean postoperative VAS score was 2.0 in the SCS cohort and 3.2 in the PRF cohort, with a standard deviation of 1.23 points. In this study, a bilateral class I error χ2) or Fisher's exact test. P < 0 : 05 was set as the significance threshold.All data analyses were carried out through SPSS software version 26.0 and are presented as median (interquartile range) or percentage . Those variables that did not conform to the normal distribution employed the Wilcoxon rank-sum test, and the count data was analyzed using the chi-square (P > 0 : 05), as shown in P=0 : 012)  .P < 0.001). Likewise, PHQ-9 reduced from 7.5 (6.0-9.3) to 3.5 (2.8-6.0) (P < 0.001), and GAD-7 reduced from 6.5 (4.5-9.5) to 3.0 (0.8-5.0) (P=0.008). Alternately, SIS enhanced markedly from 7.0 (7.0-8.0) to 0.0 (0.0-0.3) (P < 0 : 001). Similarly, the PF and BP portions of the SF-36 also exhibited marked increases from baseline 55.0 (40.0-70.0) and 31.0 (12.0–43.8) to 1-week postsurgery 87.5  and 52.0 , respectively. In the SCS cohort, we observed considerable differences in VAS, SIS, PHQ-9, GAD-7, BP, and PF of SF-36 between baseline and postsurgical 1-, 3-, and 6-month values  and from 40.0 (40.0-56.3) to 80.0 (78.8-80.0) after 1-month postsurgery (P < 0.001) (P < 0.001); SIS reduced from preoperative 7.0 (7.0-8.0) to postoperative 4.0 (4.0-4.3) (P < 0.001); and PHQ-9 reduced from preoperative 6.0 (5.0-6.0) to postoperative 4.0 (3.8-5.0) (P=0.04). Lastly, we observed no obvious difference in the GAD-7 and BP of SF-36 from baseline to 1 week, 1 month, 3 months, and 6 months after surgery. Moreover, there was also no marked difference in PF of SF-36 between baseline and at the 3- and 6-month follow-ups  . In contllow-ups .P < 0.001), 1 month (P < 0.001), 3 months (P < 0.001), and 6 months (P < 0.001) postsurgery . However, no obvious difference was noted in PHQ-9 between the two cohorts at 1 week (P > 0.05), 1 month (P > 0.05), and 3 months (P > 0.05) postsurgery (P < 0.001), 3 months (P < 0.001), and 6 months postsurgery (P < 0.001). However, it was nonsignificant at 1 week postsurgery (P > 0.05) (P < 0.001) and 6 months (P < 0.001). But, it was not significant at 1 week (P > 0.05) and 1 month postsurgery (P > 0.05) (P < 0.001), 1 month (P < 0.001), 3 months (P < 0.001), and 6 months postsurgery (P < 0.001) (P < 0.001), 1 month (P < 0.001), 3 months (P < 0.001), and 6 months postsurgery (P < 0.0011)  . The PF  > 0.05) . The BP < 0.001) . During ) Tables  and 8.We did not observe any complications or adverse effects within the 6-month follow-up duration following SCS or PRF.In this study, both SCS and PRF significantly improved the VAS score, enhanced analgesic efficiency, achieved complete relief, improved sleep quality, reduced anxiety and depression in patients, and increased PF and BP in SF-36. However, SCS provided better overall efficacy, compared to PRF. Moreover, the results from the 6-month follow-up confirmed that these interventions had prolonged positive effects. Furthermore, there were no reports of complications or adverse effects during the length of this study.The outcomes of our research are consistent with several clinical trials which documented the efficacy of SCS in managing PHN –27. In aWe assessed all PHN patients in terms of PHQ-9, GAD-7, and SIS, and our results revealed that most patients exhibited varying degrees of anxiety and depression, as well as sleep disturbances. There was a drastic reduction in the PHQ-9, GAD-7, and SIS scores in the SCS and PRF cohorts after surgery, compared to the preoperative values. Several studies confirmed that neuropathic pain induces anxiety and depression in patients . Robb coIn the current study, we demonstrated that the PF and BP in SF-36 improved significantly after surgery, with efficacy lasting for 6 months. The improvement was far more obvious in the SCS cohort, compared to the PRF cohort. As such, SCS was shown to remarkably enhance the quality of life of patients with neuropathic pain. In an international multicenter RCT involving 58 patients with diabetic peripheral neuropathy, Duarte reported EuroQol Five Dimensions Questionnaire (EQ-5D), with similar improvement to SF-36, in patients treated with SCS at the 6-month follow-up . SchmadeDuring the follow-up period of this study, no major complications or adverse effects were reported for both SCS and PRF. Other side effects were mainly wound pain, skin pruritus, and constipation. Hematoma and infection are generally considered to be major complications of SCS, but neither occurred in this study.SCS has been in practice for many years as a clinically effective, minimally invasive interventional treatment for chronic intractable neuropathic pain, with few side effects . ApproxiHowever, there is a lack of standard modality option for SCS in treating PHN, even though there are multiple SCS analgesic modalities. In addition to this, the cost of SCS treatment remains controversial. However, in the long term, the cost-effectiveness of SCS for PHN may be cheaper, despite appearing to be more expensive in the short term, compared to the PRF combination drugs.The goal of our research was to investigate the short-term efficacy of short-course SCS or PRF for PHN. Our assessment time was set at 6 months. Therefore, our limitation in this study was the lack of long-term assessment. Hence, additional investigation involving a long-term follow-up study is warranted in coming years.Both SCS and PRF can effectively treat herpes zoster neuralgia (HZ); however, SCS exhibited better efficacy than PRF.


Various psychological issues and serious health concerns during the imposed lockdown by coronavirus disease 2019 (COVID-19) have induced many changes in the treatment of patients. More effective self-management strategies through tele-rehabilitation are suggested to be applied for patients with chronic neck pain to reduce referrals to health cares and disability support through COVID-19. Also, the pain neuroscience education (PNE) approach is an educational method used by health professionals to assist patients in understanding the biology, physiology, and psychosocial factors affecting their pain experience and aligning with the cognitions and beliefs associated with pain and recurrent disability. PNE combined with tele-rehabilitation could be a new solution to encourage patients to manage their condition by themselves and increase the continuity of practice instead of face-to-face sessions.This randomized control trial (RCT) aims to investigate the effects of PNE with online and face-to-face exercise interventions, and the control group received biomedical education + standardized physical therapy on neck pain and disability, psychological factors, and function in non-traumatic chronic neck pain.α level of < 0.05. The normal distribution of the variables was verified by the Kolmogorov-Smirnov test, following a descriptive analysis.Patients with non-traumatic chronic neck pain (patient-centered care and active involvement of patients and the public) will be recruited via flyers displayed in hospitals and universities to participate in an RCT with two experimental and one control group designed to investigate the effects of PNE with online and face-to-face exercise interventions, and the control group received biomedical education + standardized physical therapy on neck pain and disability, psychological factors, and function in non-traumatic chronic neck pain. The outcomes will be measured at baseline, after PNE, and after 3 months of an exercise intervention. All outcomes are presented as mean ± SD, and statistical significance was set at It seems that PNE plus online and face-to-face exercise interventions are appropriate educational models for the treatment of patients with neck pain during COVID-19. Also, online training seems to encourage patients to continue their treatment.Iranian Registry of Clinical Trials IRCT20150503022068N5. Registered on 09 September 2021 In 70% of patients with neck pain, there is no defined diagnosis based on the structure involved and mostly no specific cause for neck pain known as nonspecific neck pain . Neck paChronic pain is defined by the International Association for the Study of Pain (IASP) as pain beyond the normal tissue healing time (more than 12 weeks) . For chrAlso, due to the coronavirus disease 2019 (COVID-19), a sudden lockdown of almost all services and activities has resulted in unexpected changes in the lifestyle of people  and has Meanwhile, exercise interventions that encourage self-management are recommended for people with chronic musculoskeletal pain –15 and aCayrol et al. suggested that pain should be evaluated based on the factors impacting pain or daily activities . PhysiciSocial and psychological factors and patient preferences are important when initiating treatment planning and building therapeutic alliances . During PNE gives comprehensive and adequate information on the nervous system’s response to harmful or potentially harmful stimuli; hypersensitivity to afferent neurotransmitters, such as swelling after acute injury; increased pain response in the central nervous system, hypersensitivity, or increased pain response; and neural plasticity, changes in the nervous system resulting from physical and cognitive activity , 19, 20.Studies have addressed the positive effect of PNE combined with motor control training or neck/shoulder exercises on reducing the present pain, physical function, depression, anxiety, stress, quality of life, and fear avoidance in patients with musculoskeletal pain , 22. HowReview studies have reported the positive effect of educational strategy based on pain neurophysiology and neurobiology on pain, disability, pain catastrophizing, and physical function , 25, 26.PNE should not be used as a separate treatment method but should be combined with other treatment strategies to increase their effect (synergy) , 27. ThiOnline rehabilitation reduces the treatment cost and provides 24/7 online support for home exercises . SupportTo our knowledge, no randomized control trial (RCT) has examined the differences in the effect of PNE with online and face-to-face exercise interventions in people with chronic neck pain. Therefore, the present study aims to investigate the differences between the effect of PNE with online and face-to-face exercise interventions on neck pain and disability, psychological factors, and function in non-traumatic chronic neck pain during COVID-19. We hypothesized that PNE with online exercise intervention could be more effective than PNE with face-to-face exercise intervention on neck pain and disability, psychological factors, and function in non-traumatic chronic neck pain during COVID-19.This study is a randomized assessor-blind controlled trial. Patients (patient-centered care and active involvement of patients and the public) with chronic non-traumatic neck pain will be recruited via flyers displayed at universities, university hospitals, and primary cares over 3 months in August, October, and November 2021in Mazandaran province, Iran. Patients interested in the study will be asked to email the researchers. All demographic data and inclusion and exclusion criteria will be gathered through online questionnaires, which will be sent in reply to patients. A physician will examine all patients meeting the criteria to ensure the selection process is carried out following the inclusion and exclusion criteria.If the patient is interested in participating in the study, after signing the informed consent control by the researchers, the baseline data will be gathered by a blind evaluator. The patient will be informed that they can leave the study at any time. Patients in each group will be excluded from the study if they have severe pain  or did not attend three sessions. After the initial evaluation, patients will be randomly assigned to one of the three study groups  . Furthermore, the protocol was approved at the Iranian Registry of Clinical Trials on 2021-10-07 (IRCT20150503022068N5).The patients with chronic non-traumatic neck pain who meet the following criteria will be accepted as participants in the trial: patients with chronic nonspecific and non-traumatic neck pain of at least 3 months, visual analog scale (VAS) greater than 3 from 10, both sexes range from 18 to 65, accept to take part in the research, and sign the information concept .The patients will be excluded if they have previous history of neck or back surgery, neurological signs, rheumatoid arthritis in the past 3 years, taking part in any other therapies, and start new medication 6 weeks prior to and during participation in this trial .Also, patients with chronic pain syndromes  will be excluded to obtain a homogeneous population .Patients can discontinue the project at any time because of participant request or improving/worsening disease. However, all efforts will be made to avoid missing data. Before starting statistical analyses, the specific way to deal with missing data will be determined at a data review meeting.After the initial evaluation, patients will be randomly assigned to one of three study groups  and pain biomechanics education (control group) by selecting numbers from 1 to 120, which will be pre-prepared and packaged in sealed envelopes by an independent person. The randomization sequence will not be disclosed until patients complete their baseline assessments. The statistician and the assessor will be blind to the group allocation. Patients will not be blind to the intervention, but do not know which group will be treatment therapy. The three groups in the study will be monitored by a physiotherapist and a corrective movement instructor.The researchers will control any adverse reports by patients through online consulting. Patients will be told to return to the research after the trial if they feel any neck pain or adverse effects.All sessions of pain neuroscience training and biomedical education for patients in the experimental groups and control group, repectively, will be performed by one of the study researchers, who will be trained in seven training sessions under the supervision of a certified physiotherapist with 10 years of experience. The principles of pain neuroscience and biomedical education, the materials, goals, agenda, and activities of each session are discussed, gathered, and reviewed by two researchers.For all patients in the two experimental groups, three sessions in 2 weeks will be held to teach PNE as well as how to perform the exercises over a period of approximately 3 months. In the first session, a power point about PNE will be presented to a group of 6 patients, the second session will be home-based online e-learning of PNE, and the third session will be a 30-min one-by-one conversation focused on the patients’ personal needs .The goals of PNE include reducing the severity of pain fear, increasing patients’ awareness of pain, and conceptualizing pain. To achieve this goal, participants must understand that all pain is produced and modulated by the brain and that their pain symptoms are often related to the sensitivity of the central nervous system rather than (persistent) tissue damage .The patient’s understanding of PNE will be asked in the second session. Then, in the third session, the therapist and patient will discuss these responses by relating the material to the PNE, and at the end of the PNE training, patients could put their pain in the correct perspective and feel less at risk of pain. Moreover, tend to do physical activities and not be afraid of or avoid movements.Neck biomechanics is focused on clinical neck injuries and is presented by Glomsud et al. and Sokop et al. 112, 113) , 35. Pat12, 113 ,These exercises will be performed to increase the endurance and strength of the flexor and deep extensor muscles of the neck  and the All patients will be going to limit their weekly exercise to the study program. The prescheduled exercises will be flexible according to each individual’s progression and limitations .All variables will be assessed initially (before intervention), after PNE (after 2 weeks), and after exercise intervention (after 3 months). The flow chart can be seen in Fig. Personal information about potential and enrolled participants will be collected, shared, and maintained to protect confidentiality before, during, and after the trial.Sex Age (between 18 and 65)Neck pain intensity in accordance with VASNeck pain history (month)Level of studies Employment situation Marital status 2])Weight (kg), height, and body mass index The primary outcome will be measured as between- and within-group differences in the Numerical Pain Rating Scale (NPRS) at the second and third assessments.The scale is 11 points for pain reporting. This is the most common pain reporting scale. The patient will choose a number according to the rule (0–10) that best indicates the severity of his pain. The number zero indicates no pain and 10 indicates the most severe or worst pain. (There are different types of numbers from 0 to 10 that one can choose). The scales are categorized as follows: painless (0), mild pain (1–3), moderate pain (4–6), and severe pain (7–10), but these categories do not necessarily reflect the patient’s meanings and for any assessments are poor. These categories may be used to set goals for the outcome of the intervention. NPRS can be done orally (by phone) or graphically. The validity of the NPRS has been shown in patients with rheumatism and other chronic pain conditions (pain > 6 months), ICC has been reported to be 0.95–0.86.40. The MDC reported from the 11-point NPRS is 0.45 .The Neck Disability Index (NDI) is a questionnaire  consistiIn each part, the patient receives a score between 0 and 5, with 0 indicating no problem and a score of 5 indicating the most problem. The total score obtained from the neck pain and disability questionnaire is between 0 and 50, which is in five levels: 0–4 without disability, 5–14 low disability, 15–24 moderate disability, 25–34 severe disability, and 35–50 disability. Its reliability and internal coherence are well reported , 41. In The Pain Catastrophic Scale (PCS) is used to assess catastrophic pain perceptions. PCS consists of 13 items scored on a 5-point scale. The total score is between 0 and 52. The higher scores indicate a more severe pain disaster . The ICCDASS-21 applies psychological distress components  on a 21-item ranking scale with scales for each item 0 “does not apply to me at all” to 3 “very” or most of the time , 48. ThiNeck flexor muscle endurance will be measured using Grimmer’s deep neck flexor endurance test . The perIt is believed if patients’ autonomy, perceived competence, and relatedness are satisfied, patients’ participation in treatment will be more autonomous and less controlled. This will occur when the patient will be given valued benefits of the treatment by his/her therapist or healthcare and then willing to participate. Also, the patient’s participation in the treatment could be enhanced through a satisfying relationship with his/her therapist . ThroughThe study was designed to identify a 2-point difference in pain intensity (30%) assessed by the NPRS across groups, with an expected standard deviation of 2.5 points . For theFor several years, treating patients with chronic pain has been more evaluated and has been given more attention due to the burden of prevalence and cost that the patient, his/her family, and society have to handle . This RCTele-rehabilitation is home-based, professionally guided training sessions accessed via telecommunication devices such as video calls or pre-recorded classes. It is mostly used nowadays because of COVID-19, which allows treatment of patients without the risk of infection for neither the patient nor the health professionals .Technological adjunctive techniques, such as remote health, have been used successfully in the rehabilitation of conditions such as stroke  and orthAlso, the results of a clinical trial by Traeger et al. (2018) have shown that the PNE approach can reduce possible referrals for health care over 3 months (but not 12 months) compared to the control group . Given tIn summary, the protocol of this RCT is inexpensive and needs minimal equipment. However, to be sure about the persistence of the results, it is suggested that this approach could be further investigated in a follow-up of 12 months.The trial is currently underway. It is planned for the study to complete by May 1, 2022.


While there are a few studies on measurement properties of PROMIS short forms for pain and function in patients with knee osteoarthritis, nothing is known about the measurement properties in patients with knee arthroplasty. Therefore, this study examined the measurement properties of the German Patient-Reported Outcomes Measurement Information System (PROMIS) short forms for pain intensity (PAIN), pain interference (PI) and physical function (PF) in knee arthroplasty patients.agr) were used. Agreement was used to determine standardised effect sizes and smallest detectable changes (SDC90). Individual-level minimal important change (MIC) was calculated using a method of adjusted prediction.Short forms were collected from consecutive patients of our clinic's knee arthroplasty registry before and 12 months post-surgery. Oxford Knee Score (OKS) was the reference measure. A subsample completed the short forms twice to test reliability. Construct validity and responsiveness were assessed using scale-specific hypothesis testing. For reliability, Cronbach’s alpha, intraclass correlation coefficients, and agreement using standard error of measurement  with slightly lower values for PAIN, and specifically for men. Cronbach’s alpha values were ≥ 0.84 and intraclass correlation coefficients ≥ 0.90. SEMOur results partly support the use of the investigated short forms for knee arthroplasty patients. The ability of PF to differentiate between patients with high perceived recovery is limited. Therefore, the advantages and disadvantages should be strongly considered within the context of the intended use.The online version contains supplementary material available at 10.1186/s41687-023-00559-x. The Patient Reported Outcomes Measurement Information System (PROMIS®) is a common health metric for many medical conditions primarily designed for computer adaptive testing (CAT) . SeveralPain and function are two relevant constructs for patients receiving knee arthroplasty. While there are a few studies on measurement properties of PROMIS short forms for pain and function in patients with knee osteoarthritis –9, nothiTherefore, the aim of the study was to determine the psychometric characteristics of the German PROMIS short forms for pain intensity (PAIN), pain interference (PI) and physical function (PF) in patients with knee arthroplasty. Specifically, we evaluated construct validity, internal consistency, test–retest reliability, responsiveness, floor and ceiling effects, and calculated the individual-level minimal important change for each scale. We used the COnsensus-based Standards for the selection of health status Measurement INstruments (COSMIN) as a guiding framework for conducting our analyses, defining thresholds, sample sizes and reporting , 15.This prospective study was approved by the Cantonal Ethics Committee of Zurich (KEK-ZH no. 2015-0258). We included consecutive patients from our knee arthroplasty registry who had undergone surgery within two cycles of extended data collection (November to December 2016 and July 2017) and received the PROMIS short forms in addition to their standard set of patient-reported outcome questionnaires  for the individual patient. Patient-reported outcomes were collected from paper questionnaires or digital versions administered 1 to 4 weeks before surgery (baseline) and at the 12-month follow-up. For reliability testing, a subsample of consecutive patients addressed for their baseline or 6-month follow-up registry survey completed questionnaires with a retest occurring within 2 to 14 days. The condition of patients before surgery was considered as stable. Also, the condition of patients 6 months after surgery tends to remain stable, as most change occurs within 3 months post-surgery . For ourSM (https://www.assessmentcenter.net/ac_scoringservice). Missing items were not replaced.We investigated PROMIS short forms for PAIN (3 items), PI and PF (each with 4 items) provided by the PROMIS Germany research group. Answers are given on 5-point verbal rating scales. For PAIN, we used the form 3a (v2.0) that assesses pain over a 7-day recall period and current pain . Form 4aThe reference measure used for this study was the Oxford Knee Score (OKS), a condition-specific instrument that assesses constructs encompassing the selected PROMIS domains. Specifically, we used the cross-culturally adapted and validated German OKS , which iHow much did the operation help your knee problem?” on a 5-point Likert scale ranging from “helped a lot” to “made things worse”. This global rating scale (transition item) was developed at our clinic and is used as an external criterion for treatment outcome. The construct validity of this global outcome scale was shown and discussed in a study on back pain patients [2 to be 0.70 and used this value for further calculations. Since pain and function deficit are among the main reasons for undergoing TKA surgery, it is reasonable to assume that for the surgery to help (or to help a lot), improvements in pain and function must be the main driver for the transition rating.Additionally, patients rated their global treatment outcome (GTO) at 12 months using a single-item transition question to rate their health change after surgery : “How mupatients . Its relpatients , which cpatients . For thepatients  using als) when non-normal distributions (Shapiro–Wilk test) were involved and the Pearson’s correlation coefficient (r) in all other cases. All correlations were expected to be large . The correlations were expected to be negative for PAIN and PI with OKS, and positive for PF with OKS.Construct validity was assessed using scale-specific hypothesis testing. This involved examining correlations with the OKS total score at baseline and 12 months, each for the total sample and by gender. Therefore, there were a total of six hypotheses per scale and the test was considered good if at least 75% of the hypotheses were confirmed . We usedp > 0.2) with the 95% confidence interval including zero, which suggests a stable condition. Test–retest reliability was assessed with the intraclass correlation coefficient (ICC) from a single measurement, absolute agreement, 2-way mixed-effects model; an ICC  ≥ 0.7 was considered acceptable [agr) = √ [agr was calculated from the mean change score. The smallest detectable change (SDC) for individuals that can be considered above the measurement error with a 90% confidence level was calculated as SDC90 = 1.65 * √2 * SEMagr [Internal consistency was calculated using Cronbach’s alpha with values between 0.70 and 0.95 indicating appropriate internal consistency . The tesceptable . Agreemeariance) . The eff* SEMagr .d ≥ 1.5 for the decrease in PAIN and PI and the increase in PF. We yielded this threshold using PF and PI CAT results from a recovery curve of patients after total knee arthroplasty (TKA) [Responsiveness defines the ability of a questionnaire to inform about clinically important changes over time. Longitudinal validity can be considered a measure of responsiveness and is examined by inspecting the correlation between change scores of the instrument under validation and the reference instrument. Change scores were calculated by subtracting baseline from follow-up scores. Considering the direction of each scale, negative change scores of PAIN and PI and positive change scores of PF and OKS correspond to an improvement in pain and function. We expected negative correlations between change scores of PAIN, PI and OKS, and positive correlations between change scores of PF and OKS, each in the order of |r|  ≥ 0.5. The smallest effect size of interest was defined by Cohen’s ty (TKA)  and a stty (TKA) .Floor and ceiling effects were considered acceptable if percentages were below 15% . BecauseROC) as well as the predicted MIC (MICpred) and adjusted predicted MIC (MICadj) following the procedure of Terluin et al. [ROC is defined as the change score cut-off to optimally classify improved and non-improved patients and was shown to be biased when the proportion of improved patients deviates from 0.5 [pred calculates the score change that is equally likely to occur in improved and non-improved patients and is also biased by group proportion [adj considers the proportion of improved patients, the reliability of the transition rating, the correlation of the change score with the dichotomized transition rating and the standard deviation of the change score. As a precondition for MIC analysis, the Spearman rank correlation (rs) between the GTO and change score should be larger than 0.3 [The minimal important change (MIC) that can be applied to the average TKA patient was calculated for each PROMIS scale from the receiver operating characteristic (ROC) curve  as well as R version 4.2.2  and the Table Scale-specific hypothesis testing resulted in four of six (75%) confirmed hypotheses for PAIN and all six (100%) confirmed hypotheses for PI and PF Table .Table 2Cagr and SDC90 were higher for PAIN and PI compared to PF. The effect size based on SEMagr was around 5 to 6 for all three short forms, and smaller than that for the OKS (9.5).Cronbach’s alpha ranged between 0.84 and 0.90 Table . The lowThe confidence intervals |r| for the correlation of change scores overlapped the threshold of 0.5 for PI and PF, and for PAIN in men only Table . The cord  values were 2.3 (1.9 to 2.8) for PAIN, 2.3 (1.9 to 2.7) for PI, and 1.7 (1.4 to 1.9) for PF. For the subsamples of women and men, Cohen’s d was in the range of 1.6 to 3.2. Thus, all hypotheses on effect sizes were confirmed. Overall, hypothesis testing for responsiveness resulted in five of six (83%) confirmed hypotheses for PAIN, and three of six (50%) confirmed hypotheses for PI and PF.Cohen’s At baseline, the worst possible score for PAIN was recorded in 5.6% of the patients. The respective percentages are 10.5% for PI and 0.7% for PF. One patient achieved the best possible score for PF, whereas there were no such cases at baseline for PAIN and PI. At follow-up, the best possible scores for PAIN, PI, and PF were achieved by 43%, 53%, and 30% of the patients respectively, which is indicative of ceiling effects and forces the distributions into  asymmetric, tailed types. The ceiling effect was consistently more apparent in men, i.e., 47% versus 19% in women for PF. The best possible OKS scores were achieved by 8% of the patients.s confidence intervals for PAIN and PI were located above 0.3 with a negligible overlap with the preset threshold of 0.3 for PF . The percentage of improved patients was 92%. The results for the three MIC approaches are shown in Table The GTO showed moderate to large correlation with the short form change scores: rIn this longitudinal study with patients receiving TKA, we investigated the measurement properties of three PROMIS short forms by using the condition-specific OKS as the reference instrument.Construct validity was confirmed for all three PROMIS short forms, but PAIN showed lower correlations than the other two scales. This might be explained by the factor structure of the OKS. It was confirmed as a unidimensional scale representing a higher-order combined construct of pain and function  and it cagr, SDC90) could hypothetically be influenced by the number of patients answering with the best possible score on both occasions, test and retest (18% to 20%). Therefore, we conducted an a posteriori analysis with results shown in Additional file We identified good internal consistency and test–retest reliability for the 3- to 4-item PROMIS short forms for pain and function. This is in line with results from Deyo et al. who investigated the measurement properties of the 4-item PF and PI short forms within the PROMIS-29 profile in adults with chronic musculoskeletal pain . They red retest 8% to 20%Responsiveness was acceptable for PAIN and PI, but limited for PF. Specifically, the confidence intervals of correlation with the OKS change scores were overlapping with 0.5. We required the whole confidence interval to be located above 0.5, which is rather conservative. Nevertheless, the observed overlap indicates that our data are compatible with correlations below the preset threshold, and this may be due to the precision level of the estimates based on the sample size we used, especially for the male subsample. It might also be due to the ceiling effects found in the PROMIS short forms affecting the distribution of change scores see Fig. . We re-cadj ranged from 3.5 to 7.15 and were smaller than the MICs derived from other calculation methods (8.12 to 12.9). Of note, the large confidence intervals of MICadj for PI and PAIN indicate that our point estimates may be imprecise. Our MIC estimates are partly in line with reported values from others. For example, Hung et al. reported the MICROC for PROMIS PF CAT as a T-score change of 8 for an orthopaedic patient population with hip and knee joint disorders (68% improved patients) [ROC is overestimated when the proportion of improved patients is larger than 0.5 [There is a knowledge gap on MIC thresholds for the investigated PROMIS scales in knee arthroplasty patients. In addition, there is still a wide variety of terminologies and calculation methods used for the concept(s) of MIC and its estimation. We agree with the recent recommendation advocating anchor-based over distribution-based methods for determining meaningful change estimates . In receatients) . Accordithan 0.5 . We detethan 0.5  and estithan 0.5 . Most liagr, which means that the joint-specific OKS allows a more detailed grading of patient recovery than the generic PROMIS short forms for pain and function.Compared to the OKS, all short forms show smaller effect sizes based on SEMFor the follow-up of knee arthroplasty patients, the high proportion of patients with best possible scores for PI and PAIN after surgery may not be critical. These scales represent unipolar constructs where the absence of pain can no longer be differentiated. However, the ceiling effect for PF is problematic. Researchers should be careful in interpreting PF short form score changes. If the maximum score is reached by an individual, their current functional state might be underestimated, and further improvement cannot be measured. This problem may be resolved by using PF CAT without substantially increasing respondent burden. The OKS, which incorporates both pain and function, did not show such a ceiling effect.Only 67% of eligible patients responded at baseline and 56% at follow-up. We excluded the largest group of patients who are, in fact, currently being followed up for a condition affecting their other knee, and this was done to decrease response burden. The second largest group of excluded patients, who were either living abroad or did not speak German, lack the most basic characteristic essential for validating German language questionnaires and had to be excluded to ensure study population representativeness. From our internal registry quality control procedures, we know that “lack of time” is the most common reason for not responding and less than 3% refused to cooperate because they were dissatisfied with their treatment, which suggests that this study was not prone to a major source of selection bias.Because our sample comprised primarily participants from German speaking Switzerland, this aspect might nonetheless limit the generalisability of our results. Our OKS baseline score is comparable to that reported for two British TKA cohorts from the period 2010 to 2016 (n = 575) , but is Regarding the GTO, we are aware that the external criterion measure we used might not be ideal in terms of recommendations given for transition ratings, for example, the use of balanced 7- to 11-point numerical scales with written descriptors on the ends and at the midpoint . We acknagr and SDC90. Results of the analysis without ceiling cases can be found in the Additional file The ceiling effects observed in the test–retest samples led to a slight underestimation of SEMReasons for using PROMIS short forms may be that one wants to use a generic measure to compare different patient groups while the possibility for using CAT technology is missing. In our study using the shortest available short forms, we showed that this strong reduction to 3 to 4 items comes at the expense of responsiveness and that one loses measurement accuracy in patients with good recovery. This fact needs to be strongly considered within study planning. Responsiveness determines the power of a study and good responsiveness is the key to detect differences between treatments .While we could provide a lot of valuable information about measurement properties of the PROMIS short forms for pain and function using data from our routine clinical registry, there is still some uncertainty about MIC thresholds since the confidence intervals around our point estimates are large.Additional file 1. Supplement Table 5. Reliability, agreement and smallest detectable change calculated from test-retest sample excluding patients presenting the best possible PROMIS short form scores on both test occasions.


To evaluate the effects of cryotherapy on pain scores and satisfaction levels of patients during cataract surgery under topical anesthesia. Eighty patients aged between 55 and 75 years scheduled for cataract surgery were randomly allocated to two study groups to receive topical anesthesia with cryotherapy (TC) or topical anesthesia alone (T) groups. Visual analog pain scores, patient satisfaction level, hemodynamic parameters, and quality of operating conditions were recorded.P = 0.018). Cryotherapy as a complementary method with topical anesthesia reduced pain scores of patients during surgery. It also produced a better quality of operating conditions for surgeons. There was no significant difference in either postoperative pain scores or opioid consumption.Cryotherapy significantly reduced VAS pain scores during surgery (P = 0.014). Although no significant difference in postoperative pain scores, opioid consumption, heart rate, and mean arterial blood pressure was seen in the postoperative period. The surgeon reported better quality of operating conditions in the TC group (Trial registration This trial was registered at Iranian clinical trial registering: IRCT registration number: IRCT2017052734091N2The online version contains supplementary material available at 10.1186/s13104-022-06125-w. Cataract surgery is one of the most common surgical procedures in men and women aged between 50 and 80 . The mosThe analgesic role of low temperatures during cataract surgery, even without the association of topical anesthetics was described , 5. The Due to the controversial reports about the analgesic effects of cryotherapy during cataract surgery, the present study was conducted to compare patient-reported pain intensity during cataract surgery with topical anesthesia versus topical combined to cryotherapy.In a prospective, double-blinded randomized trial, 80 patients were recruited for cataract surgery by phacoemulsification after the approval of the Institutional Ethics Committee and written informed consent. The consolidated standards of reporting trials (CONSORT) recommendations for reporting randomized controlled clinical trials were followed. Inclusion criteria were patients aged 55–75 years scheduled for elective cataract surgery with intraocular lens implantation using phacoemulsification under topical anesthesia for the first time according to the American Society of Anesthesiologists (ASA) physical status classification I–III. Exclusion criteria were patients with sleep disorders, depressive disorder, or expected compliance problems (known psychiatric disease), epilepsy, insufficient pupillary dilation, nystagmus, deafness, ongoing treatment with hypnotics or psychotropic drugs (including opioids) within a week before admission, daily analgesic NSAIDs treatment. All patients received 3 mg of melatonin one hour before entering the operating room to reduce anxiety.Eighty patients aged between 55 and 75 scheduled for cataract surgery were randomly allocated to two study groups to receive either topical anesthesia with cryotherapy (TC) or topical anesthesia alone (T) using a computer-generated randomization schedule. Allocation was managed by a resident external to the project and the study drugs given by a nurse noninvolved in the study. The anesthetist was blinded to the patient’s group assignment, and the study data were recorded by a blinded observer. All solutions to be instilled during the operation, except the povidone drops, were cooled to around 4C. Mydriasis was achieved by tropicamide 1%. No patient received preoperative sedation. An eye mask of cold gel (Eyes Pack Single) was placed over the eye for about 10 min before surgery. After washing the periocular skin with chlorhexidine 0.5%, ocular asepsis was achieved using povidone 5% drops. The intraocular irrigation was performed by a solution at room temperature (approximately 23 °C) in group T and 4 °C in group TC. The solution for group TC was kept in a refrigerator at approximately 4 °C temperature. The storage advised by the manufacturer was 2–27 °C. The same surgeon performed all surgeries. The lens opacity was almost the same in both groups, according to the LOCS.Phacoemulsification was performed through a temporal clear corneal incision technique. An applicator was used to hold the globe to avoid touching the conjunctiva or sclera. In group TC, during phacoemulsification, the cornea was kept chilled with cold BSS. The lens nucleus was hydro-dissected with cold BSS irrigation.No other sedative or analgesic agent was used. At the preoperative visit, the Visual analogue pain scores (VAS) ranged from 0 to 10 (0 = no pain and 10 = worst pain imaginable). Patients were monitored by an electrocardiogram, noninvasive measurement of blood pressure, and pulse oximetry (SPO2). Pain scores were recorded for each patient several times: before premedication (T1), 60 min after premedication, on arrival at the operating room (T2), during the operation period (T3), and also postoperatively before discharge from the recovery room (T4). The primary outcomes of this prospective, double-blinded randomized trial were to evaluate the severity of patient’s pain and satisfaction level during the operation period. At the end of the surgery, the patients were asked about the severity of their pain during the operation period according to the VAS criteria explained before premedication.After surgery, the sedation level of patients was measured according to the modified Ramsay score scale using a 3-point scale with 1 = anxious, 2 = calm and oriented, 3 = calm and drowsiness.Complications such as respiratory depression, headache, nausea, vomiting, and chills were also recorded.Postoperatively, the operating surgeon, who was unaware of patient assignment, was asked to assess the adequacy of intraoperative conditions according to the following scale: excellent , good . Patient satisfaction was also assessed by the Iowa Satisfaction with Anesthesia Scale (ISAS) , 10. Thet-test analysis was used for continuous parametric variables. Nonparametric data were expressed as the median interquartile range. The pain scores and patient satisfaction were compared between groups by Fisher’s exact test; otherwise, the Mann–Whitney U test was used. A P value < 0.05 was considered significant. Statistical analysis was carried out using SPSS version 16 for Windows .According to a previously published study , consideWe excluded ten out of 90 patients due to logistical issues or other violations of the study protocol. Eighty patients were randomly assigned to two groups. There were no significant differences between the two groups regarding the demographic features including age, gender, and duration of surgery [Data are in Additional file As shown in Table Patients with sedation scores below four were given fentanyl at a dose of 1 μg/kg. The relative frequency of patients who received fentanyl was not significantly different between the TC [n = 21 (48.8%)] and T [n = 22 (51.2%)] groups (p = 1.000).As shown in Fig. No patient developed hypoxia, hypotension, bradycardia, excessive drowsiness (or sleepiness), and vomiting during the surgery. The postoperative side effects did not show a statistically significant difference between the two groups. Only one case of chills and one case of headache were recorded in the TC group. In the control group, we recorded three incidents of nausea and two cases of headache. [Data are in Additional file cryoanalgesia clear corneal phacoemulsification and topical anesthesia are almost equal. They suggested that cryoanalgesia is a suitable technique for anesthetic allergy cases [The findings of our study revealed that cryotherapy is a complementary method with topical anesthesia and has a significant positive effect on pain intensity during surgery and surgeon satisfaction. This finding is partly consistent with a previous study by Gutierrez-Carmona et al. . which dgy cases .While, in the Coelho et al. studies, which were performed on patients undergoing cataract surgery, no significant difference was observed in the amount of pain between the topical anesthesia versus topical combined to cryotherapy .However, it seems that methodological differences in the studies can explain some of these contradictions. For example, the number of surgeons, surgery on one or both eyes, different groups of patients in terms of age and sex, different pain sensitivity and perception of patients and different tools to assess the amount of pain and also the type of medication prescribed to reduce patients' anxiety. Furthermore, the old age of patients and the lack of accurate answers to the questionnaire can also be another reason for the discrepancies in the results.Nevertheless, it is known that cryotherapy having anti-inflammatory and analgesic effects . CryotheAnother mechanism suggested for the analgesic effects of cryotherapy is cold-induced vasoconstriction, which can reduce blood flow to the target tissue and reduce the release of inflammatory mediators, and also, it promotes the accumulation of local anesthetic in the target tissue , 11. FinThe other notable finding is that the level of sedation of patients in both groups was not statistically significant. That's probably, all patients in the ward were given 3 mg of melatonin one hour before entering the operating room.In the same way, the patient satisfaction numbers (IOWA) were the simillar in both groups in our study.Since the excessive sedation and decreased cognitive function leading to loss of patient cooperation with the surgeon, and also make the evaluation of patients' pain inaccurate. Thereby, to avoid bias, in the present study, one hour before entering the operating room, we used melatonin as an anxiolytic drug to increase patient satisfaction. In previous studies, the anxiolytic effect of melatonin without cognitive dysfunction was demonstrated as a pretreatment in various surgeries .Another finding of this study was the greater satisfaction of the surgeon in the cryoanalgesia group. The lower pain scores of patients during surgery in the TC group seemed to be directly related to the surgeon's satisfaction.Although, our study had some limitations; old age of patients and low level of their cooperation to answer the questions of the inevitable questionnaire. We recommend future studies in patients with bilateral cataracts.The findings of the present study revealed that cryotherapy as a complementary method with topical anesthesia could reduce patients' pain scores during surgery and enhance surgeon satisfaction.Our study had some limitations; old age of patients and low level of their cooperation to answer the questions of the inevitable questionnaire. We recommend future studies in patients with bilateral cataracts.Additional file 1: Fig. S1. Consort flow diagram.Additional file 2: Table S1. Demographic data.Additional file 3: Table S2. Comparison of surgeon satisfaction in two groups.Additional file 4: Table S3. The relative frequency of pain intensity in two groups.Additional file 5: Table S4. Comparison of postoperative side effects in the two groups.


Temporomandibular disorders (TMD) is a term used to describe a set of clinical conditions that may compromise the temporomandibular joint (TMJ) and masticatory muscles and/or associated structures, considered the most frequent cause of orofacial pain of non-dental origin. In recent years, many forms of physical therapy have been used in the treatment of TMD to reduce pain and improve the range of mandibular movement present in this impairment. Among these resources are kinesiotherapy (exercise), electrothermal and manual therapy, acupuncture, training posture, mobilizations, and biofeedback.  To determine if exercises with or without occlusal splints are effective in reducing pain in patients with temporomandibular disorders (TMD) of myogenic origin. This systematic review was registered in the International Prospective Register of Systematic Reviews (CRD 42019134244). Controlled trials published in PubMed, Scopus, and Cochrane Library following PRISMA guidelines up to April 2022 were randomized and included. The population above 18 years, which evaluated the effectiveness of exercise with or without occlusal splints in reducing pain in patients with TMD of myogenic origin, diagnosed through the Research Diagnostic Criteria for Temporomandibular Disorders, was also included. There was no restriction on the period of publication. Cochrane risk of bias analysis was performed. Of the five included articles, all showed a reduction of pain, but without significant differences between the interventions performed. Additionally, studies that evaluated the quality of life and mandibular movements showed a reduction in pain, but no significant differences between therapies. The analyzed studies showed no difference in the improvement of pain, quality of life, and mandibular movements between the groups that performed only exercises or the associated treatments. Studies showed that increased stress is associated with the appearance of muscular tension, which affects the functioning of the stomatognathic system and TMJ.10While TMD is uncommon in childhood, its prevalence increases in adolescence and young adulthood, affecting people mainly in the age range of 20 to 40 years. Females are the most affected, presenting greater symptom severity and experiencing more difficult recoverying.11Occlusal splints (OS), which promotes the relaxation of the masticatory muscles, has been widely used aiming to restore neuromuscular balance. Moreover, it repositions the mandibular condyles and normalizes the proprioception of the periodontal ligament, providing a correct alignment of the temporomandibular joint. Such removable device is made of acrylic resin with polymer and can be used during the day or at night.16TMD is a multifactorial pathogenesis, and its treatment must be interdisciplinary, combining a conservative approach, cognitive behavioral therapy, physical therapy, and pharmacology intraoral devices where applicable.17In recent years, many forms of physical therapy have been used in the treatment of TMD to reduce pain and improve the range of mandibular movement present in this impairment. Although the literature lacks consensus on the best treatment for this disorder, some therapies such as kinesiotherapy (exercise), electrothermal and manual therapy, acupuncture, training posture, mobilizations, and biofeedback can be used in the management of TMD.20Orofacial exercises have been one of the main interventions in the management of TMD. Aiming to promote the proper functioning of the cranio-cervico-mandibular region, strength, mobility, coordination, the relaxation of the jaw muscles, the increase of range of motion of the TMJ, proprioception, and muscle relaxation, this intervention brings positive effects on pain. The exercises must be part of an individualized program, in addition to the need for verbal and written instructions.This study aimed to perform a systematic review of the literature to verify if exercises with or without the OS are effective in the reduction of pain in patients with TMD of myogenic origin. The hypothesis of the study is the physical therapy exercises associated with the occlusal splint are more effective in the treatment of pain in myofascial TMD.21and were registered in PROSPERO under protocol No. CRD 42019134244.This systematic review was conducted based on studies published in PubMed, Scopus, and Cochrane Library that followed PRISMA  guidelines“Are exercises with or without the OS effective in reducing pain in patients with TMD of myogenic origin?” Here, “P” was “patients with TMD of myogenic origin”; “I” was “physical therapy exercises”; “C” was “use of the OS + physical therapy exercises”; and “O” was “pain assessment (primary) and quality of life and mandibular movements (secondary).”The problem, intervention/indicator, comparison, and outcome of interest (PICO) question guiding this study was the following: Randomized clinical trials published up to April 2022 with a population above 18 years, which evaluated the effect of exercise with or without occlusal splints (made of acrylic) in the reduction of pain in patients with TMD of myogenic origin, diagnosed using the Research Diagnostic Criteria for Temporomandibular Disorders (RDC/TMD), were included. There was no restriction on the period of publication.Studies that used other tools for TMD diagnosis, assessed TMD unrelated to muscle origin, or included patients with diseases that could affect masticatory muscles or the TMJ, were excluded.Two authors (JFOLB and JMLG) independently performed the electronic search in the databases PubMed/MEDLINE, Cochrane Library, and SCOPUS. The keywords and MeSH descriptors were combined with Boolean operators for each database, as in The selection process was conducted in two phases. In the first phase, two independent evaluators (JFOLB and JMLG) read the titles and summaries of the studies identified in the databases searched. Studies that did not meet the inclusion criteria were discarded. In the second phase, the same researchers applied the eligibility criteria to the full text of the articles. During the searches, disagreements were resolved by a third reviewer (MVH).Inter-examiner evaluation (kappa test) was performed to verify the level of agreement between the authors during the search and selection of the articles.One author (JFOLB) collected the relevant data from the articles, which were then verified by two other authors (JMLG and MVH). The qualitative data collected included author/year/country, study design, follow-up, age group, intervention , assessment instrument for pain outcome, results , conclusion, and effect.The bias risk analysis was performed by two independent authors (BCEV and SLDM) using the Cochrane risk of bias tool. For each manuscript, the items’ allocation confidentiality, the possibility of randomization, blinding, and patient loss were examined. Finally, the studies were categorized according to the level of risk of bias as “low,” “medium,” or “high”.The database search yielded a total of 1.111 studies in the databases as follows: 374 Pubmed/MEDLINE, 166 Cochrane Library, and 571 SCOPUS. After the exclusion of duplicated studies (368), 743 studies were evaluated through the reading of titles and abstracts. Among the 31 articles remaining for full-text evaluation, after applying the eligibility criteria, 27 were excluded for several reasons. Manually searching, we found one article that met the inclusion criteria. Finally, five articles were part of the data extraction and qualitative synthesis. The inter-examiner test (kappa) showed “moderate” to “almost perfect” agreement according to the criteria (K=0.88) for each database.22 2013,212015,222017,27 and 2018.24Regarding geographic distribution, one study was conducted in Brazil, while the others were conducted in Finland,24 the Netherlands,27 and India.21The age range of the study populations was broad, covering both young and adults.2720 five months,22six months,21and one year.24 In one study,27the follow-up time, dependent on the rate of symptom improvement, differed for each patient. Regarding the treatments performed, four studies associated exercise with occlusal splints,24and only one study27used separate therapies and compared the groups. Additionally, all studies24included advice on parafunctional habits, diet, and pain management.The follow-up period varied among the studies: one month,24or isolated therapies.27Only one study24evaluated the quality of life related to oral health (QLROH), observing an improvement in the dimensions of physical capacity and eating discomfort, regardless of the treatment used. Niemelä, et al.22(2012) and Katyayan, et al.21 (2013) evaluated mandibular movements and reported that the splints treatment was not more effective than exercises for increased mandibular mobility.In our review, we found that there was a reduction in pain between the initial assessment and after the intervention, but no significant difference regarding whether the studies used the occlusal splints with exercises27although none of them met all the criteria for methodological quality since some information was unclear. All included studies were classified as low risk of bias according to the Cochrane risk of bias tool,28 The OS used in studies26 was made from heat-cured acrylic. According to Conti, et al.12 (2012) the occlusal splints promotes central, peripheral, and behavioral changes, reduces muscle activity, and improves occlusal stability. Melo, et al.16 (2020) also states that OS restores neuromuscular balance by promoting balanced condylar contact of the TMJ.This study aimed to verify whether exercises alone or associated with occlusal splints are effective in reducing pain in patients with TMD of myogenic origin. Therefore, RDC/TMD was used as the inclusion criterion, since it is considered the gold standard for diagnosis of TMJ dysfunction and is the protocol used over the diagnosis.29Deregibus, et al.3 (2021), in their randomized clinical trial (RCT), guided participants to use it at night, for at least 8 hours, while Melo, et al.16 (2020) stated that OS can be used in the morning or at night, depending on the patient’s clinical condition, which must be analyzed by a specialist. We should note that the Finnish guidelines recommend that splints should be used at night because it is uncomfortable to use during the day owing to work activities, school, and feeding.30However, the literature lacks consensus about the optimal period and time of occlusal splints usage.Regarding the protocol of splints use, patients were instructed to use it overnight, except for one study that advised that the splints should be used as long as possible or for at least 10-12 hours at night.26 (2018), Niemelä, et al.22 (2012) and Katyayan, et al.23 (2013) implemented the protocol proposed by Carlsson and Magnusson30 (1999). This program consists of mouth opening, lateralization, and protrusion, actively and with maximum maintenance of the positions for a few seconds; it is, essentially, exercises that incorporate resistance from the patient’s fingers. These exercises are repeated from seven to ten times and performed two to three times per day. Costa, et al.24 (2015) used stretching and elongation exercises three to five times per second. Already Van Grootel, et al.25 (2017) performed the Jacobson method, which promoted the relaxation of the mandible muscles in addition to stretching, mandibular movement, and self-massage.Regarding the exercises used, Kokkola, et al.31 (2020) state that mandibular exercises should be individualized aiming to improve muscle coordination, increase the range of motion, and relax strained muscles. There is no standardization of the exercises used to treat TMD, as to patient compliance with therapy, appropriate dosage, and exercise frequency. Despite this, it is possible to compare studies because of commonalities regarding relaxation, active movements, and stretching.Fernández-de-las-Peñas and Piekartz26was the use of guidelines, advice, and instructions on the etiology and prognosis of the disease, diet, and parafunctional habits to avoid. Costa, et al.24 (2015) stressed the importance of sleep hygiene and the application of hot cushions on painful muscles. They also stated that counseling and behavioral changes were effective in relieving headaches attributed to TMD because the use of the occlusal splints did not offer any additional therapeutic effect. This reinforces the need for a more comprehensive protocol, involving professional intervention as well as counseling strategies and behavioral changes since these approaches are reported to be a valuable tool for the management of myofascial pain.12 Studies observed that patients with masticatory muscular pain have alterations in respiratory patterns, depression, and sleep disorders. Therefore, interventions that address bio-behavioral strategies, alone or in combination with other therapies, could help alleviate pain.32A common point in all studies26 as well as the study comparing individual therapies, that is, only the OS compared with exercises,25 concluded that the treatments were effective in improving pain. However, no significant difference was observed between the treatment group and control groups.26We should highlight that OS and exercise therapy have similar success rates,18 with their efficacy being confirmed through follow-ups.28 Therefore, according to Van Grootel, et al.25 (2017) the key to the choice of treatment is patient compliance and preference.The studies combining OS and exercises, making a comparison with only exercises,26 (2018), who found that although the patients experienced an improvement in physical pain and discomfort when eating, no difference was observed between the interventions (OS and exercises vs exercises). However, TMD-related pain has a greater impact on QLROH than dental problems, and it is also known that patients with TMD suffer more, especially regarding the physical pain of TMD.34The impact of pain on the quality of life in patients with TMD was assessed only by Kokkola, et al.22 (2012) who observed improvement after one month of treatment. However, there was no difference between the interventions performed (exercises + orientation vs OS + exercises + orientation). The improvement in movements was achieved in both groups and cannot be attributed only to the OS. Therefore, the improvement was more likely achieved because of the information received and the positive effects of both treatment methods used. The author also reported an adverse effect—increased pain upon palpation—in the splints group.Mandibular movements were evaluated by Niemelä, et al.23 (2013) also observed an improvement in mandibular movements between the beginning and after six months of treatment, but no significant difference between the groups. The author also emphasizes the need for further studies with sufficient sample sizes to assess the effectiveness of treatment with an occlusal splints on symptoms in TMD of myogenic origin.Katyayan, et al.Some methodological limitations in the included studies are that the samples were patients who intentionally sought treatment or who had been referred from orofacial pain centers. Additionally, the studies did not use the same treatment protocol for both exercise and splints use. Because of the heterogeneous nature of the data, which made quantitative synthesis difficult, performing a meta-analysis was impossible.The analyzed studies showed no difference in the improvement of pain, quality of life, and mandibular movements between the groups that performed only exercises or the associated treatments. Due to the heterogeneity of the studies analyzed, further research is needed.


Objectives: Non-specific low back pain affects people of all ages and is a leading contributor to disease burden worldwide. Chronic low back pain (LBP) reduces working hours, increases comorbidities, and increases rehabilitation needs. The aim of this study was to evaluate whether there were differences in pain, dysfunction, and psychological factors between two groups. The supplementary demonstrated the relationship between these influencing factors and anxiety.Methods: A cross-sectional study was designed to analyze the differences in pain, disability, and psychological function in non-specific LBP patients with and without anxiety. In total, 60 subjects were divided into two groups based on self-rated anxiety scores: 30 patients with SAS score ≥50 were in the low back pain with anxiety group, and 30 for the LBP without anxiety group with SAS score <50. The pain intensity was assessed using the Visual Analog Scale; psychological function, using the Pain Anxiety Symptoms Scale, the Tampa Scale for Kinesiophobia, and the Fear Avoidance Beliefs Questionnaire; functional disability, using the Oswestry Disability Index and the Roland–Morris Disability Questionnaire; quality of life using 36-Item Short-Form Health Survey questionnaire; and the quality of sleep using Pittsburgh Sleep Quality Index, and the relationships between variables and anxiety scores were estimated using Spearman correlation analysis.Results: A total of 60 participants were enrolled after self-rated anxiety was assessed and the full investigation was finished. The analyses showed significant differences of pain intensity  and psychological function  between the two groups. Spearman correlation analysis showed that the anxiety score had significant positive correlations with functional disability  and psychological function , excellent positive correlation with quality of sleep , and strongly negative correlations with the quality of life .Conclusion: We recognized that anxiety in low back pain patients was mainly due to interaction with the intensity of pain, disability level, and a mass of psychological function. The future research direction could be to alleviate the anxiety on the comprehensive efficacy of patients with low back pain. In recent years, low back pain (LBP) has become a common cause of musculoskeletal disorders which leads to disability, reduced work hours, and the need for rehabilitation . In 2015Any dysfunction has a variety of psychological effects, and many studies have shown that people with LBP have somatic, emotional, and psychological problems ; these fAwareness of the relationship between anxiety and characteristics such as pain, dysfunction, and mental factors in LBP patients provides important information that could be used to predict treatment effects and prognosis, and also help select the optimal treatment method and self-management. The Lancet Low Back Pain Series working group calls for the concept of living well with low back pain : this meThis was a cross-sectional study to analyze differences in pain, disability, and psychological function in LBP patients with and without anxiety. The investigation was performed in the Rehabilitation of Shanghai Shangti Orthopedic Hospital, Shanghai, China, from June 2021 to January 2022. The data collection was completed by the author RW, reducing the potential for error arising from different operators. All participants understood the process of the study and signed informed consent prior to the assessment. The Ethics Committee of Shanghai University of Sport approved this study (number 2018069).The calculation of sample size was obtained from previous studies that reported the pain difference of low back pain patients with anxiety, through G-power  . The resThe pain intensity was assessed with a Visual Analog Scale (VAS), which is a self-reported scale using a 10-cm line to verbally describe the pain status indicated at each end . The higα = 0.92) and can be used as an effective assessment tool for an anxiety state  is a commonly used self-rating scale for mental problems, which consists of 20 items that include both psychological and somatic anxiety symptoms . Each itty state .α = 0.92, ICC = 0.90) in a simplified Chinese version  was used to measure the fear of pain and pain-related sensations . The 40- version .The Tampa Scale for Kinesiophobia (TSK) was developed to assess fear of movement-related pain in patients with musculoskeletal pain. TSK-17 is widely used; it contains 17 items, each item rated from 1 (strongly disagree) to 4 (strongly agree); and total scores vary from 17 to 68. A higher score indicates more fear of movement . The TSKα = 0.82; FABQ-P, α = 0.75; and FABQ-W, α = 0.85 (The Fear-Avoidance Beliefs Questionnaire (FABQ) focused on patients who thought about how physical activity (FABQ-P) and work (FABQ-W) affected their current low back pain . FABQ isα = 0.85 . Understα = 0.85 .The Oswestry Disability Index (ODI) is a self-assessment measurement scale primarily designed to assess the degree of disability in patients with low back pain . Ten evaThe Roland–Morris Disability Questionnaire (RMDQ) was designed to evaluate dysfunction in patients with LBP, which comprises 24 questions closely related to LBP selected from 136 questions in the Sickness Impact Profile . The RMDThe 36-Item Short Form Health Survey questionnaire (SF-36) is a very common scale for evaluating health-related quality of life (HRQoL) . The scaThe Pittsburgh Sleep Quality Index (PSQI) is a self-reported questionnaire to assess sleep quality and disturbances for more than 1 month. The questionnaire has seven subscale scores of nineteen individual items . Each sup > 0.05); all numerical variables of the normal distribution are represented as mean ± standard deviation (SD), while abnormal distribution, in terms of the interquartile range (Q1–Q3). The chi-square test was used for the comparison between groups when the variables were classified variables. T-test was used to compare the differences in SF-36, PASS, FABQ-total, and FABQ-W between patients with and without anxiety because of its normal distribution. A non-parametric test was used to compare the differences in VAS, ODI, RMDQ, TSK, and PSQI between patients with and without anxiety, due to abnormal distribution. Spearman correlation analysis was carried out to analyze the relationships between pain intensity, disability, psychological function, quality of life and quality of sleep, and anxiety. The Spearman correlation coefficient might range from +1 (positive correlation) to −1 (negative correlation), as 0 indicates no association between the two variables, and greater values indicate stronger associations between variables; values were interpreted as little relationship, fair, moderate, and excellent relationship with values <0.25, 0.25–0.50, 0.50–0.75, and ≥0.75, respectively . The graph was drawn with GraphPad. We performed descriptive statistics on the baseline characteristics of two groups, after normal distribution was checked , PASS , FABQ total , FABQ-W , ODI , PSQI , and TSK , and less than 0.05 in RMDQ , FABQ-PA , VAS-R , and VAS-S . It indicates that LBP patients with anxiety had higher pain intensity and disability level, seemed more afraid of pain and pain-related activity, and had lower quality of life and sleep.To examine whether two groups (low back pain with anxiety and low back pain without anxiety) differ in pain intensity, disability, and psychological function, we performed r = 0.290, p = 0.025), ODI , RMDQ , PSQI , TSK , FABQ-W , FABQ total , and VAS-S , and strongly negative correlations with SF-36 . The quality of life and sleep were significantly correlated with anxiety symptoms of LBP.The Spearman correlation analysis was conducted to reveal the relationships between anxiety and pain intensity, disability, and psychological function in all patients. The results in Patients with low back pain who suffer from pain and dysfunction for a long time will be affected both mentally and physically. In recent years, it has become important to explore the related influencing factors of low back pain patients from multiple dimensions under the biopsychosocial model. This cross-section investigated the relationship between pain, disability, psychological function, and anxiety in LBP patients. We found that there were statistically significant differences between LBP patients with anxiety and those without anxiety in these aspects. However, severe pain score was not correlated with anxiety, and daily life quality and sleep quality were strongly correlated with anxiety, while TSK and FABQ-work were moderately correlated, and other factors were weakly correlated with anxiety.Pain intensity is a common outcome measurement to assess the effect of therapy and quantify the degree of chronic LBP. It is a personal experience influenced by multidimensional factors, such as genetic, psychological, cultural, and social factors . There iODI and RMDQ are popular in assessing dysfunction in patients with LBP; in recent years, many studies have focused on the relationship between psychological factors and disability. They found that dysfunction was weakly associated with mood  , which iOur results show that TSK and FABQ-W are moderately correlated with anxiety in LBP patients (2A and 2D). Kinesiophobia is a form of exercise protection; its value is that it can predict an individual’s degree of disability by comparing it to the intensity and duration of clinical symptoms, pain, and anxiety . The maiQuality of life is a very important outcome of LBP patients, which is affected by multiple dimensions, primarily mobility, followed by anxiety or depression, and the conclusions of this study complement the findings by Insomnia is very common among people with chronic pain, and is often thought to be a consequence of chronic pain, but the findings demonstrate a bidirectional relationship with pain . There iDespite the new findings in this study, the following limitations still exist: 1) as a cross-sectional study, this study cannot determine causality; 2) a small sample size was included, and the conclusion about the predictive ability of the included factors was limited. Therefore, a longitudinal study with a larger sample size is needed to further explore the relationship and mechanism of various influencing factors in LBP patients.Although the relationship between symptoms of LBP and anxiety is very weak in addition to the quality of life and quality of sleep, the problem still commonly exists in patients with LBP; in view of this, psychotherapy should be an integral part of a multidisciplinary rehabilitation training strategies, psychological consultant for patients with anxiety, and other negative emotions control strategy of education to improve their psychological state. In terms of the treatment of chronic LBP, we should pay attention to the emotional changes of patients as soon as possible, adopt the method of multidisciplinary cooperation and management to put forward targeted psychological intervention measures, so as to reduce the pain degree of patients and improve the psychological status of patients.In this investigation, it was possible to identify some of the psychological and physiological characteristics involved in low back pain anxiety. To sum up, we recognized that anxiety in LBP patients interacts with the intensity of pain, disability level, and a mass of psychological function; therefore, these factors influence the effectiveness of treatment, and clinicians are recommended to pay attention to and offer the comprehensive evaluation and individual intervention.