Neck pain is a frequent health problem. Manual therapy (MT) and transcutaneous electrical nerve stimulation (TENS) are recommended techniques for treatment of mechanical neck disorders (MND) in Spanish Public Primary Care Physiotherapy Services. The aim of this study was to compare the efficacy of MT versus TENS in active mobility and endurance in cervical subacute or chronic neck pain. Ninety patients with MND were randomly allocated to receive ten 30-min sessions of either MT or TENS, in a multi-centered study through 12 Primary Care Physiotherapy Units in the Madrid community. Active cervical range of motion (CD-ROM) and endurance  were evaluated pre- and post-intervention and at 6-month follow-up. A generalized linear model of repeated measures was constructed for the analysis of differences. Post-intervention MT yielded a significant improvement in active mobility and endurance in patients with subacute or chronic MND, and at 6-month follow-up the differences were only significant in endurance and in sagittal plane active mobility. In the TENS group, no significant improvement was detected. With regard to other variables, MT improved mobility and endurance more effectively than TENS at post-intervention and at 6-month follow-up in the sagittal plane. Only MT generated significant improvements in cervical mobility and endurance in the three movement planes. Nowadays neck pain is a frequent health problem associated with modern lifestyles , and is The annual prevalence of neck pain with disability, but without structural damage, varies between 1.7% and 11.5% in the general population . It has Although treatments such as nonsteroidal anti-inflammatory drugs and dry needling are usually first-in-line in the field of referred pain, such as orofacial pain , the effMT intervention, which includes manipulation, mobilization, massage, and neuromuscular techniques , has notRegarding the use of electrotherapy, there have been studies of clinical trials with a small number of patients with MND that compared TENS with other treatments, without finding differences between groups post-intervention ,33,40,41On the other hand, biomechanics and psychological factors have been identified in the transition from an acute to a chronic pain syndrome. In MND without an injury, it is considered that chronification is due to biomechanical overloading. If pain relief is the only aim of the treatment, then functional disorders  can persist and be precursors of future deficiency biomechanics and chronification of MND ,43,44.No study that compares the efficacy of both techniques on mobility and endurance has been found. The aim of the present study was to compare the effects of MT and TENS techniques on cervical active mobility and muscle endurance in patients with subacute and chronic mechanical neck disorders. A research of pain intensity relief has been previously published . It was A multi-centered randomized clinical trial was performed in order to compare the effectiveness of MT versus TENS in patients diagnosed with subacute and chronic MND without neurologic signs according to the Quebec Task Strength Classification on Spinal Disorders  , (Spain).Subjects included were patients between 18 and 60 years old, who were treated in 12 primary health care physiotherapy units that took part in the study in the Madrid region. Exclusion criteria were as follows: signs of neurological damage, pregnant women, previous neck rachis surgery, patients who received physical therapy or an alternative treatment of the neck or shoulder 6 months prior to the beginning of the study, or those with important psychiatric disorders or other health problems that would contraindicate the techniques to be used . Patients with neck pain caused by an inflammatory, neurological, or rheumatic disease, severe osteoporosis, fracture, luxation, or vertebrobasilar insufficiency were also excluded.Consecutive patients with chronic neck pain referred by their primary care physicians and who met the inclusion criteria  and signed the informed consent were recruited. Blinded allocation, concealed in closed envelopes, was on the basis of block randomization and was carried out also by the primary care physical therapists. Random sequences of 6 patients, assigned by external researchers, were obtained using the statistical program Epidat 3.1© , in order to create 2 equivalent groups.Patients were evaluated pre-intervention, post-intervention, and at 6-month follow-up. The evaluations were assessed by a different group of physical therapists, so outcome variable evaluation was blinded. A detailed description of the trial’s protocol has been published previously by the investigation group .Ninety patients from the multicenter randomized clinical trial were included. The final potency of the study to detect clinically relevant changes (10/100 points) with the neck disability index (NDI) was 91.4%. Sample size determination was calculated according to the NDI, because data related to clinical significance of active mobility and cervical endurance were not found.Based on the consulted bibliography, if the neck pain has a muscle-skeletal origin, a clinically relevant result appears when there is a change over 5/50 points in the NDI . In thisTherefore, TENS and MT interventions each consisted of 10 sessions, provided by primary care physical therapists for 30 min on alternate days. Applied MT techniques included those which in the Primary Care Physical Therapy Clinical Guidelines. These techniques were regularly used by most of the physical therapists in their daily clinical practice. In this way, the MT techniques consisted of the following: neuromuscular technique, post-isometric stretching, spray and stretching technique, and Jones technique ,49,50. TDuring the planning of the study, the physical therapists received 1 session of training to assure homogeneity between the different interventions. The physical therapists that performed the interventions did not have knowledge of the patients’ evaluation data. Every unit received the necessary material  instrument, basic inclinometer).Outcome measures of the study were the active range of motion (AROM) and the endurance of the neck muscles, which were registered at first in the 6 movements of the cervical spine, and after this were recorded in the 3 space planes, adding up the degrees of movements in each plane.Neck mobility was measured with an inclinometer, the CROM Basic Cervical Range of Motion Instrument  , which iEndurance of the cervical muscles was measured using the Palmer and Epler test ; it is aOther studied variables  that could have an influence on active mobility and endurance were age, gender, physical disability  were performed by physical therapists who disclaimed treatment of each patient. To minimize losses, patients who did not assist in the revision session were phoned at least twice.Quality control was performed by the coordinating center (Primary Care Research Unit), with periodic supervision and feedback on the study process and data entry; progress reports were performed every 2 to 4 months and meetings with the research physical therapist, every 6 months.Statistical analysis was performed without revealing which treatment each patient had received. First, a descriptive analysis of the different studied variables in each intervention group was performed, in order to verify the homogeneity between both groups by using statistical tests.Analysis of the intervention’s effectiveness was evaluated by protocol comparing the mean value of the answer variables in each of the space planes between both intervention groups pre-intervention, post-intervention, and at 6 months’ follow-up intervention. For this purpose, a general linear model of repeated measures was used, performing a simple contrast, where the reference value was the measurement at the beginning of the study (pre- intervention).Finally, several models of multiple linear regression were carried out for the mobility and endurance: 1 model for each of the space planes, 1 and 6 months after the intervention.p < 0.05) were kept in the model.Variables that were significant in the bivariate analysis and the variables that could cause a confounding phenomenon or interaction were added to the models. It was considered that adjustment was necessary to correct confounding bias if the change in the regression coefficient between the adjusted and unadjusted effect was over 10%. The interaction was studied with statistical significance tests for the parameters, and the interaction terms that were statistically significant (2) and Mallow´s Cp. At all times the hierarchy principle was sustained. The statistical program SPSS© 17.0  was used to process and analyze the data.Once the maximum model was defined, a gradual inclusion process by steps was performed and guided by the investigators, establishing as a criterion the square value of the adjusted multiple coefficient of determination  of 94–200 days. Overall, 71 patients (80%) completed the follow- up measurement at 6 months, and the number of losses was similar in both groups.p = 0.03 U Mann-Whitney Test)), are shown in Sociodemographic characteristics and prognostic variables at baseline in each of the intervention groups, . Even though at 6-month follow-up adverse effects in the TENS group were double those in the MT group, statistically significant differences were not found at both time points in the study (post-intervention and at 6-month follow-up).Results of this study showed that post-intervention MT significantly improved active mobility and endurance in patients with subacute or chronic MND, but at 6-month follow-up the differences were only significant in endurance and in sagittal plane active mobility. In the TENS group, no significant improvement was detected either post-intervention or at 6-month follow-up. When measuring the effect of the interventions (MT or TENS) considering other variables, MT improved the mobility and endurance post-intervention and at 6-month follow-up in the sagittal plane to a greater extent than TENS.It is important to point out that between the confounding and/or modifying variables of our study, it seemed that pain at baseline did not have as important an influence on the outcome measures as the physical disability measured with NDI, independently of the type of intervention, especially at 6-month follow-up. The higher score on the NDI, the larger the increase of mobility after the intervention, which meant that from a worst functional baseline, there seemed to be greater potential for recuperation and a larger range of movement obtained.The latest and rigorous Neck Pain Clinical Practice Guidelines ,14,37 prIn the same way, for subacute or normal recovery neck pain, they suggest offering multimodal care, manipulation or mobilization, range-of-motion home exercise, or multimodal manual therapy , as wellIn no case did these Guidelines recommend the use of TENS based on scientific evidence with indications comparable to the findings of the present study. On the other hand, a recent meta-analysis of TENS for relief of spinal pain published by Resende et al.  concludeIn this same sense, Häkkinen et al.  comparedZaproudina et al.  comparedIn the study of Tuttle et al. , specifiIn a clinical trial, Heikki and Hemmilä et al.  comparedIn the same way, Korthals de Bos  concludeAs regards the effects of TENS in the mobility of patients with neck pain, Nordermar et al.  comparedOn the other hand, Dusunceli et al.  found thAn increase in neck muscle endurance seems to be associated with a decrease in neck pain. In earlier studies, muscle pain has been reported to affect motor control, possibly leading to functional deficit ,68,69. JAccording to the studies of Häkkinen et al. ,71,72, iChiu et al.  studied According to the indications of the PRECIS tool , the desOn the other hand, the difficulties encountered during our investigation were described in a previous publication . In the As a matter of practical applicability, in the present study, only MT was proven to be useful in increasing active cervical mobility and endurance in patients with neck pain. Adverse effects from the application of this therapy are almost nonexistent and of little clinical importance. Therefore, MT is recommended for treating these patients. According to a recent systematic literature review and meta-analysis , manipulAs future research, it would be interesting to investigate whether improvements in isometric strength or endurance are more effective in terms of functionality and decreasing relapses in these patients ,41. BiomIt would be necessary to conduct more trials as well as pain education sessions to gain a better understanding of patient satisfaction and expectations  and perfOnly MT had proven to be useful to increase active cervical mobility in the three planes and endurance in patients with neck pain. The adverse effects of the application of this therapy are almost nonexistent and have little clinical significance. Therefore, MT is recommended for treating patients with neck pain.


Blunt chest trauma (BCT) accounts for up to 65% of polytrauma patients. In patients with 0 to 2 rib fractures, treatment interventions are typically limited to oral analgesics and breathing exercises. Patients suffering from BCT experience symptoms of severe pain, poor sleep, and inability to perform simple daily life activities for an extended period of time thereafter. In this trial, we aim to investigate the efficacy of acupuncture as a functional and reliable treatment option for blunt chest trauma patients.The study is designed as a double-blind randomized control trial. We will include 72 patients divided into 2 groups; the acupuncture group (Acu) and placebo group (Con). The acupuncture group will receive true acupuncture using a uniquely designed press tack needle. The control group will receive placebo acupuncture treatment through the use of a similarly designed press tack needle without the needle element. The acupoints selected for both groups are GB 34, GB 36, LI 4, LU 7, ST 36, and TH 5. Both groups will receive 1 treatment only following the initial visit to the medical facility and upon diagnosis of BCT. Patient outcome measurements include: Numerical Rating Scale, Face Rating Scale, respiratory function flowmeter, Verran Snyder-Halpern sleep scale, and the total amount of allopathic medication used. Follow-up time will be scheduled at 4 days, 2 weeks, and lastly 3 months.The results of this study can potentially provide a simple and cost-effective analgesic solution to blunt chest trauma patients. This novel study design can serve as supporting evidence for future double-blind studies within the field of acupuncture.The study will be conducted in the thoracic surgical department and acupuncture department in China Medical University Hospital, Taichung, Taiwan. The study will be conducted on blunt chest trauma patients and is anticipated to have minimum risk of adverse events. Enrollment of the patients and data collection will start from March 2020. Study completion time is expected in March 2022.(CMUH109-REC1-002), (NCT04318496). In the case of preserved organ function, it is the bony structures and soft tissues which are most commonly affected by BCT injury. According to previous literature, BCT patients can be divided into 3 levels based on the severity of injury as identified by chest plain film findings. Level 1 includes patients without rib fractures; level 2 includes patients with 1 or 2 rib fractures; and level 3 includes patients with more than 2 rib fractures. Based on retrospective studies, level 3 patients experience increased frequency of hospitalization, thoracotomies, and a higher mortality rate. Levels 1 and 2 patients are commonly treated as out-patients, but still suffer greatly from chest pain and tend to experience breathing difficulties.,3 The pain associated with the BCT injury may in turn lead to the inability have sufficient sleep, with the resultant lack of rest impeding the recovery process. The most commonly used conventional treatments are analgesics.,5 Moreover, while nerve block surgical intervention is also practiced as a treatment intervention, it is commonly reserved for level 3 patients experiencing severe pain and/or thoracic deformity.,5 While analgesic medication can relieve pain temporarily, most patients still suffer prolonged nociceptive hypersensitivity and usually have difficulties in performing daily life activities for sometime after. Furthermore, elderly and renal insufficiency patients are at a higher risk of experiencing harmful effects from long term use of analgesics and muscle relaxants.The rib cage and associated anatomical structures are responsible for protecting the vital organs located within the chest cavity.–9 Accordingly, in order to maintain an unbiased approach, the acupuncture intervention of this particular study will be compared to a placebo intervention. Our study implements a novel design that maintains clinical efficacy, through the use of press tack needles and similar placebos that look identical, hereby ensuring blindness of both the patient and the acupuncturist.For thousands of years, acupuncture has been used in the treatment of all kinds of traumatic injuries. Moreover, in recent decades, stimulation of acupuncture points for the treatment of visceral pain, post-operative pain, cancer pain, and chronic pain is well established and has been widely investigated in a number of clinical trials.With a goal to improve the analgesic effect and life quality in patients suffering from BCT, we designed a double-blind study comparing press tack acupuncture to press tack placebo interventions. In the trial, we aim to investigate the efficacy of press tack acupuncture based on traditional acupuncture concepts and point locations. Furthermore, we hypothesize that press tack acupuncture will have a superior analgesic effect when compared to press tack placebos.22.1The study is designed as a single-center randomized control, parallel-arm, double-blinded trial. It will take place in the out-patient clinic of China Medical University Hospital. The study will be conducted from March 2020 to March 2022. The study was approved by the institutional review board of China Medical University Hospital (CMUH109-REC1-002), and was registered on clinicaltirl.gov (NCT04318496).The main goal of the study is to reduce pain and improve the respiratory function and sleep quality of patients after BCT. The participants will be divided to 2 groups; acupuncture group (Acu) who will receive the true press tack needles, and a placebo group (Con) who will receive press tack placebos on the same acupoints without the needle element. Patient outcome measurements include: Numerical Rating Scale (NRS), Face Rating Scale (FRS), respiratory function flowmeter Verran Snyder-Halpern sleep scale (VSH), and the total amount of allopathic medication used.2.2We will include a total of 72 patients who are suffering from BCT. After the patient's accident, such as falls, kicks, fights, or traffic accidents, they will be sent to the emergency room and visit a chest surgical out-patient clinic for treatment and follow-up. Those who meet the inclusion criteria will be informed about the study and can freely choose to participate. They will sign the informed consent and will be randomized accordingly, with commencement of the study occurring immediately. The patients are allowed to drop out from the study at any time point of the study.2.3Age 20 to 80 years old.Patients who have chest trauma as described by themselves or based on medical chart records within 1 week of injury.Injury Severity Score (ISS) is less than 18 points.Body mass index < 30.2.4Sternal fracture.ISS is equal to or more than 18 points.History of intercostal nerve injury.History of cardiovascular disease.History of chronic lung disease.Significant lung mass or chest deformity noted in the chest plain film.2.5From the informed consent discussion and form, the intervention, risks, benefits, and patient's rights in the study will be explained in a simple language that patients can clearly understand . The informed consent will be signed by the patient or by a legal guardian. In the circumstance that they wish to withdraw from the study, our strategy is to use the available data for the final analyses and accommodate the patients’ wishes accordingly.2.6The participants will be randomized into 2 groups with a 1:1 ratio produced by the SPSS program software, version 22. A computer-based simple random sampling with a 1:1 ratio without stratification will be used. A number (1–72) will be affiliated to each patient at the time of their first visit to the out-patient clinic and after completing the informed consent. The number, patient name, and date of birth will be written down on a non-transparent envelope by a study nurse 1 (researcher EB-A). Inside the envelopes, there will be 14 separate sterile press tack needles or identical looking press tack placebos. The envelopes in both groups will appear identical. Study nurse 1 will write down the number, patient name, and intervention in an electronic chart and create a file for each patient.2.7Study nurse 1 will be responsible for randomization and prepare the needles in the envelopes. Outside the envelopes, there will be a number belonging to 1 patient, and inside the envelopes, there will 14 separate sterile needles which can be either true press tack needles or press tack placebos. The envelopes and the pouch of needles will look the same. The acupuncturist will be asked not to check the needles when they insert them. At the time of acupuncture, a nurse will accompany the acupuncturist and will verify that he/she is not examining the needles closely. Study nurse 2 will perform the outcome measurement tests. The acupuncturist, patients, and study nurse 2 will be blinded to patient allocation.2.8The participants will be divided into 2 groups. One group will receive press tack needle acupuncture (Acu); the other group will receive press tack needle placebos without the needle element (Con). Both groups will receive 2 individual treatments on the same set of acupoints. The needle retention time will be 4 days. Needle withdrawal will be done by the acupuncturist or acupuncture nurses who have trained in needle withdrawal techniques in the out-patient clinic Fig. .2.9Φ0.20 mm × 0.6 mm made by Seirin Corporation) have a diameter of 0.2 mm and a length of 0.6 mm. Each needle is packed separately in a sterilized pouch. As for the placebo, the individual press tack and pack are identical to the press needles, except the needle element has been removed. Both interventions will be performed by a qualified acupuncturist and a medical doctor with at least 1 year of experience in acupuncture practice.In the protocol, the press tack needles , GB 34 (YangLingQuan), ST 36 (Zusanli), LI 4 (HeGu), LU 7 (LieQue), TH 5 (Waiguan) were chosen for both groups. Each patient will receive 12 press tack needles in total. The needle's depth of insertion will be 0.6 mm. The acupuncturist will manually press the press tack needles over the above-mentioned acupoints without any needle manipulation or “De Qi” sensation. The participants will lay on the treatment bed for the duration of 30 minutes. After the aforementioned process, the vital signs, pain levels, and flowmeter will be recorded again to represent the immediate effect after acupuncture. Finally, the acupuncturist will educate the patients about the total number of press needles and the allotted time of retention. The press tack needle retention time will total 4 consecutive days.2.11The participants in the placebo group will experience the same treatment course including the selection of acupoints and associated outcome measurement recording. However, the placebo group participants will receive press tack placebos . The press tack stickers on the skin surface are identical but without any needle penetrating the skin. The placebo sticker retention time will be the same as in the acupuncture group, totaling 4 consecutive days Figs.  and 3.2.12Both groups of participates will also receive the prescribed analgeasic medication and/or muscle relaxants. The frequency of the prescribed medicine is 3 to 4 times a day along with meals and before sleep for 7 days. The purpose of the medication is for pain relief, therefore, the participants can discontinue the medication at will.2.13The main outcome measurement will be the pain levels of both rest and mobile status for the BCT patients . The patient will measure their pain according to 3 subjective pain scales, namely the NRS, and FRS before treatment, 30 minutes after treatment and 4 days after the press tack needles/placebo intervention. Furthermore, a follow-up will assess the NRS pain scale telephonically at 14 days and 3 months after the initial intervention.3 per second to elevate. 1200 cm3 is the highest score and indicates good exhalation power. The above process will be done before intervention, 30 minutes after intervention and 4 days after the intervention. The patient will also answer the VSH sleep scale in Mandarin to evaluate the sleep quality of the night before the clinic visit. They will complete the questionnaires accordingly at every clinic visit, for a total of 2 times (on day 1 and day 4). Finally, on the 4th day after the initial intervention, participants will bring back the prescribed medication, including analgesics and/or muscle relaxants that were left unused, to be measured for the amount of medication used.Secondary outcome measurements will include the improvement of respiratory function, sleep quality, and amount of medication used . We used the portable triflow flowmeter and VSH sleep scale as objective tools for the aforementioned purposes. The patients will be educated on the use of the flowmeter by the affiliated thoracic surgeon. Patients will be allowed as much time as needed to practice the use of the flowmeter before the first measurement is taken. When the patient is ready, the study personnel will commence the measurements of 3 attempts, and will record the best 2 attempts. The triflow flowmeter measures the amount of air the patient can exhale; it has 3 chambers with their own balls that require air pressures from 600 to 1200 cm2.14After the initial visit to the chest surgical out-patient clinic, the participates in both the Acu and Con groups will be expected to return 4 days after acupuncture/placebo treatments for needles/placebos withdrawal along with chest plain film, NRS, FRS scores, flowmeter, respiratory function, VSH sleep scale assessments, and amount of medication used. On the 14th day and at 3 months after the initial intervention, a study personal will arrange a telephonic consultation to enquire about the pain scale (NRS) and any adverse effect related to the acupuncture treatment and the chest trauma . The demographic data between Acu and Con groups including gender, age, and clinical characteristics will be compared using the Student's U and the Wilcoxon sign rank test will be implemented accordingly. Missing data will be analyzed using the pairwise deletion method.Subgroup analysis will be done based on the following: age, sex, number of treatments complete, number of hours of needle retention, number of rib fractures, pulmonary complications, hospitalization, number of days from patient's injury to the first treatment, Triflow score, medication use, body mass index, and ISS. In cases of small sample size, the Mann–Whitney 3 In the case of BCT, nociceptive signals are transmitted to the brain following peripheral tissue damage. In terms of the 1 to 10 NRS pain scale, the patient's pain levels on the first recorded day of injury can reach up to 9 to 10 points, whereafter the pain sensation gradually decreases and is subsequently recorded at reduced levels of 2 to 3 points after 15 days. However, the long term effects of pain resultant from physical injury usually display concurrent overlapping conditions related to the physical, psychological, and even socio-economic function ability of patients, and can last up 12 months after initial injury.The nociceptive response is a reflexive bodily response of the body aimed at providing protective mechanisms. In short, pain creates awareness of pathological conditions resultant from injury or harm, and may vary in intensity, quality, duration, and referral. Accordingly, pain is categorized according to 4 distinct types: nociceptive pain, inflammatory pain, neuropathic pain, and functional pain.–19 In terms of acute pain, acupuncture has displayed promising analgesic effects in a wide array of diseases, with particular emphasis on emergency medicine.–22 Furthermore, acupuncture has displayed tendencies of increased efficacy in the treatment of bone fractures as shown in elders in the acute stage of hip fracture. In addition, patients who received acupuncture treatment in the ambulance en route to hospital, reported reduced pain sensations, less anxiety, and lower heart rates. They also stated a higher overall satisfaction regarding the emergency ride to the hospital.Acupuncture treatment is well known for its analgesic potential, with proven efficacy particularly in chronic pain conditions. Furthermore, the therapeutic benefits of this treatment are extended to complicated conditions of maladaptive pain, such as myofascial pain, tension headache, irritable bowel syndrome, etc. Other possible explanations of acupuncture analgesia include the evident reduction in common inflammatory mediators such as substance P, IL-1β, IL-8, IL-10, and TNF-α, all of which are over-expressed in nociceptive hypersensitive states, specifically inflammatory pain, and functional pain conditions.The analgesic effects of acupuncture have been further biochemically described via research obtained from various animal studies. The underlying molecular mechanisms of acupuncture analgesia are commonly associated with an increase in adenosine and an upregulation of the A1 receptors that are largely associated with anti-nociceptive effects.,25 In the randomized control trial, Ho et al focused on the patients with 2 or more rib fractures requiring hospital admission (level 3). These patients were usually well monitored and treated with adequate analgesic mediations during their hospital stay. When patients classified according to level 1 or level 2, without rib fractures or with less than 2 fractures, respectively, are treated in the out-patient clinic, the pain control measures are limited, especially when intravenous (IV) medications are not available.Current literature contains limited information with regards to the use of acupuncture treatment in cases of BCT. Accordingly, only 1 randomized control trial and 1 case report about the benefit of acupuncture for the blunt chest injury was discovered. Doctors discovered that the injuries of internal organs or the torso could be treated via the stimulation of the distal skin surface, such as the limbs, ears, or skull. They drew lines to connect specific points, and developed a map of the 14 meridians, each of them is related to a specific organ system. In the present study, we utilize this concept through the use of distal point stimulation of 4 limbs to ease the chest pain associated with traumatic incidences without directly applying needles at the site of injury.To this end, acupuncture provides suitable, reliable, and effective forms of relief for these patients. The efficacy of Chinese Medicine in the treatment of various conditions has been proven over thousands of years. For this protocol, we had chosen the press tack needles and press tack placebo due to their simplicity and similarity which allows for effective blinding. The press tack needles look identical to the press tack placebo, whereby one can only see a difference at the time of needle insertion and withdrawal upon extremely close inspection of the needles, and thus they can serve as an ideal device to generate the “blindness” effect to both the patients and the acupuncturist. The “De Qi” phenomena, which is usually achieved through manipulation of the acupuncture needles via rotation is considered by some as a major part of the acupuncture effect, and might be lost in the application of press tack needles, thus being regarded as the press tack needles’ biggest disadvantage.,30 However, as we want to apply the use of acupuncture in a conventional allopathic, we believe that the press tack needles can provide a simple to use and safe treatment option for all modalities of medical care. In this study protocol, we decided to implement the following acupoints: GB 34 (YangLingQuan), GB 36 (Waiqiu), LI 4 (HeGu), LU 7 (LieQue), ST 36 (Zusanli), TH 5 (Waiguan), as a result of similar theoretical affiliations. Specifically, the concept associated with these specific points is directed at the fact that most chest trauma occurs on the frontal and lateral areas of the chest. Accordingly, Chinese medicine theory describes the frontal area of the chest as being controlled by the yang ming layer (stomach and large intestine meridians), to which end the acupoints: LI 4 (HeGu) and ST 36 (Zusanli) belong to that layer and can potentially generate an analgesic effect within the specified area. The lateral side of the chest is purportedly controlled by the shao yang layer , whereby the acupoints GB 34 (YangLingQuan), GB 36 (Waiqiu), and TH 5 (Waiguan) can potentially improve Qi and blood flow within this specific region and alleviate pain.,31 The addition of the acupoint LU 7 (LieQue) was designed to treat the lung organ and improve lung functions. The acupoints ST 36 (Zusanli) and LI 4 (HeGu) were found to decrease incisional pain and improve post-operative rest in post abdominal surgery patients. The acupoints LU 7 (LieQue), LI 4 (HeGu), ST 36 (Zusanli), TH 5 (Waiguan) also showed a general analgesic benefit and increased post-operative recovery.With regards to the manipulation of acupuncture needles for increased therapeutic benefit, a multitude of options are available, including manual acupuncture, electro-acupuncture, press tack needle, laser acupuncture, etc.3.1The study provides an effective intervention but is limited to a shallow acupuncture needling depth of the superficial subcutaneous layers and cannot be associated with the benefits caused by the deeper stimulations commonly associated with most acupuncture interventions. Furthermore, the point selection in this study only concentrates on anterior and lateral BCT locations. Lastly, the follow-up method of telephone calls at 14 days and after 3 months can prove problematic, and a high loss to follow-up is anticipated.In this study, we offer a simple, low-cost form of acupuncture that, if it will prove superior analgesic effects in comparison to the placebo, can provide a safe and reasonable treatment alternative to BCT patients.We would like to acknowledge the Seirin Corporation for providing the acupuncture and placebo press tack needles. We would also like to acknowledge Dr Bernice Lottering for her assistance in the editing of this paper.Analysis and interpretation of the data: Ho Wen-Chao, Eyal Ben-Arie, Kao Pei-Yu.Conceptualization: Pei-Yu Kao, Eyal Ben-Arie, Yu-Chen Lee, Fang-Pey Chen.Data curation: Pei-Yu Kao, Wen-Chao Ho, Fang-Pey Chen.Design: Eyal Ben-Arie, Kao Pei-Yu, Lee Yu Chen, Fang-Pey Chen.Formal analysis: Wen-Chao Ho.Funding acquisition: Kao Pei-Yu, Fang-Pey Chen.Investigation: Pei-Yu Kao, Ting-Yu Lu, Yu-Sen Lin, Chien-Kuang Chen, Jian-Xun Chen, Tzu-Min Huang.Methodology: Pei-Yu Kao, Eyal Ben-Arie, Wen-Chao Ho, Yu-Chen Lee, Fang-Pey Chen.Patients enrollment: Kao Pei-Yu, Ting-Yu Lu, Yu-Sen Lin, Chien-Kuang Chen, Jian-Xun Chen, Tzu-Min Huang.Project administration: Pei-Yu Kao, Eyal Ben-Arie, Yu-Chen Lee, Fang-Pey Chen.Resources: Pei-Yu Kao, Yu-Chen Lee, Fang-Pey Chen.Software: Eyal Ben-Arie, Kao Pei-Yu, Ho Wen-Chao.Supervision: Pei-Yu Kao, Yu-Chen Lee, Fang-Pey Chen.Validation: Wen-Chao Ho, Kao Pei-Yu.Visualization: Pei-Yu KaoWriting – original draft: Pei-Yu Kao, Eyal Ben-Arie.Writing – review & editing: Pei-Yu Kao, Eyal Ben-Arie, Yu-Chen Lee, Fang-Pey Chen.


To investigate the efficacy of repeated application of capsaicin 179 mg cutaneous patch in nonresponders to the first application.Post hoc, as-treated analysis of two prospective trials (STRIDE and PACE) with 52-week follow-up.Open-label.Multicenter clinical trial.STRIDE: nondiabetic neuropathic pain; PACE: painful diabetic peripheral neuropathy.Patients were divided according to number of applications needed before attainment of a ≥30% reduction in average pain intensity (question 5 of the Brief Pain Inventory [BPI-Q5]). We assessed the change from baseline in average pain intensity (BPI-Q5), mean “interference with sleep” score, Patient Global Impression of Change, quality of life (QOL) via the EuroQol 5-dimension, and Self-Assessment of Treatment.In STRIDE and PACE, respectively, n = 306 and n = 313 received the capsaicin patch; n = 60 and n = 96 had a response after the first application, n = 33 and n = 68 after the second, and n = 11 and n = 43 after the third. Among patients without a ≥30% reduction in pain intensity at 3 months, in STRIDE and PACE, respectively, 23.3% and 28.1% achieved a ≥30% reduction at 6 months, increasing to 33.9% and 45.7% at 12 months. Similar results were obtained when a decrease of ≥50% was used as the responder definition. Progressive improvements in pain intensity in slower responders reached levels similar to those in early responders at month 12 and were accompanied by improvements in sleep, QOL, and patient satisfaction.Although some patients with peripheral neuropathic pain experience rapid improvements with a single treatment of capsaicin 179 mg patch, some may require two or three treatments before an initial response is observed. Similar benefits for pain, sleep, and QOL can be achieved in early and late responders. Neuropathic pain (NeP) is a common neurological disorder with an estimated worldwide prevalence of 7–10% , and indCapsaicin is a potent and highly selective agonist of the transient receptor potential vanilloid 1 (TRPV1), an ion channel–receptor complex expressed on skin nociceptive nerve fibers. Topical administration causes prolonged depolarization of sensory afferents, leading to defunctionalization of hyperactive nociceptors in the skin and hence to pain relief . This de® ) allows for deposition of high concentrations of capsaicin directly into the skin [The capsaicin 179 mg 8% w/w) cutaneous patch   and in pIn both trials, repeat treatment was well tolerated, with little deterioration in sensory function , 14. FurThe assessment of the evolution of responder rates  is important to understand the contribution of each application of the capsaicin 179 mg cutaneous patch to the overall result. These results have been reported only partially for PACE and not yet for STRIDE. Given the high granularity of the data collected in these two clinical trials, it is feasible to assess the decrease in pain scores and thus responder rates after successive treatments with the capsaicin 179 mg cutaneous patch. The objectives of the present post hoc analysis of data from STRIDE and PACE were to investigate 1) whether there is any evidence of efficacy of the capsaicin 179 mg cutaneous patch in patients who did not achieve a pain response after the first application and 2) how many separate applications may be reasonable before reaching a conclusion on whether or not to continue treatment.This was a post hoc, exploratory analysis of data from two prospective, multinational, open-label trials of repeat treatment with the capsaicin 179 mg cutaneous patch over 52 weeks. STRIDE (NCT01252160) was a phase 4, single-arm, observational, safety trial in patients with nondiabetic peripheral NeP; all study subjects were treated with the capsaicin 179 mg cutaneous patch with repeated applications at 9- to 12-week intervals . PACE (N2) were applied at any one visit. In STRIDE, applications to the feet lasted for 30 minutes, and applications to other body locations lasted for 60 minutes [In both trials, a maximum of four patches .Retreatment with the capsaicin 179 mg cutaneous patch was undertaken according to investigator discretion and patient feedback .Both trials were approved by relevant institutional review boards and independent ethics committees, as per local requirements, and were conducted in accordance with the Declaration of Helsinki and other applicable guidelines. Written informed consent was obtained from all patients before initiation of study-related procedures.Full details of the inclusion and exclusion criteria for STRIDE and PACE are available elsewhere , 14. BriFor the present analysis, patients were divided according to how many applications of the capsaicin 179 mg cutaneous patch were needed before they achieved a response . Specifically, this assessed responders after one vs two vs three applications, and others . Patients who responded after a first, second, or third treatment could also receive further applications .The present analysis focused on the following outcomes in each group: change from baseline in average pain intensity, derived from responses to question 5 of the BPI ; change from baseline in mean “interference with sleep” score, derived from responses to question 9 F of the BPI ; QOL according to EQ-5D, assessed on a visual analog scale; and patient-rated Self-Assessment of Treatment (SAT), assessed at study end on a five-point Likert-type scale ranging from –2 (a strong negative response) to +2 (a strong positive response). Before each application of the capsaicin 179 mg patch, patients filled out a PGIC question in which they rated their perceived change in their condition, assessed on a scale of 1 (very much improved) to 7 (very much worse). The PGIC measures taken before an application reflected the patient’s experience of the previous application. Reasons for study discontinuation and use of concomitant pain medications  were also assessed in each responder group.In this post hoc analysis, descriptive statistics are provided as appropriate, including mean and standard deviation for continuous variables and frequency and percentage for categorical variables. Missing data were not imputed.In STRIDE, 306 patients received treatment with the capsaicin 179 mg cutaneous patch . PACE included 468 patients with PDPN randomized to the capsaicin 179 mg cutaneous patch (30 minutes) plus SOC (n = 156), to the capsaicin 179 mg cutaneous patch (60 minutes) plus SOC (n = 157), or to SOC alone (n = 155). In the present analysis, data from PACE were evaluated only for the two groups that received the capsaicin 179 mg cutaneous patch (30 or 60 minutes) plus SOC (n = 313).Full baseline characteristics are described elsewhere , 14. In Among patients who did not have a 30% reduction from baseline in pain intensity 3 months after the first treatment, approximately one quarter were responders at 6 months , and more than a third had a response at 12 months  . SimilarAn analysis of changes in pain intensity by responder category demonstrated the expected rapid responses (within 1–2 months) in patients who responded after the first application of the capsaicin 179 mg cutaneous patch . These rReductions in sleep interference from baseline by responder category showed a pattern similar to that of the declines in pain intensity . There wThe proportions of patients who reported being “very much improved” or “improved” on PGIC also paralleled the improvements in pain . Figure Improvements in patient QOL assessed with the EQ-5D followed a similar trend, albeit less clear than with PGIC.Rates of patient satisfaction  were higher for all five domains of SAT among responders than among other patients , irrespective of whether patients needed one, two, or three applications of the capsaicin 179 mg cutaneous patch to achieve a response . This suAs would be expected, treatment discontinuations among nonresponders in both trials resulted primarily from lack of efficacy or withdrawal of consent . In bothDifferential use of concomitant pain medication is a potential confounder of the analysis of responses. Across trials and in all three subgroups, pregabalin or gabapentin were more often discontinued than initiated. Opioids were initiated in a slightly higher proportion than discontinued in those responding after the first and second treatment across trials , and henThroughout STRIDE, the mean interval between retreatments was 105.4 days. It appeared to be longer in patients who responded after one application (116.7 days) than in those who responded after two (103.1 days) or three applications (94.5 days). The mean interval between retreatments in nonresponders was 103.5 days.In PACE, the mean interval between retreatments was 66.6 days, and it was similar in patients who responded after one application (65.9 days), two applications (65.1 days), or three applications (63.8 days) and also in nonresponders (69.9 days).It has been previously suggested that effectiveness further increases with repeated applications of a capsaicin 179 mg cutaneous patch ; howeverPrevious studies investigating possible predictors of response to the capsaicin 179 mg cutaneous patch were based on randomized controlled clinical trials focusing on a single application, not taking into account that some patients may not respond to a single treatment but become responders with subsequent applications , 20. TheHowever, recently it was noted by clinicians that, in clinical practice, patients can benefit from repeated applications irrespective of response to a first application. This concept of progressive improvement is not inconsistent with the pattern of response observed with other treatments associated with chemodenervation. For example, in The Chronic migraine OnabotulinuMtoxinA Prolonged Efficacy open-Label (COMPEL) Study trial, repeated use of onabotulinumtoxin A in chronic migraine was associated with continued gradual improvements in response over the course of nine treatment cycles across 2 years . FurtherA recent study of the capsaicin 179 mg cutaneous patch in patients with chemotherapy-induced peripheral neuropathy provides a potential mechanistic explanation for the progressive response . In thatNociceptor sensitization over time  may alsoThe present analysis also found improvements in sleep interference with the capsaicin 179 mg cutaneous patch that followed a time course similar to that of the reductions in pain intensity. This suggests that pain reductions may have been the main reason for sleep improvements. However, TRPV1 blockade has been associated with altered sleep modulation in animal models , and henIn the original publication of STRIDE, it was noted that the area affected by NeP decreased with repeat applications . This inWe should acknowledge the key limitations of the present work. Most importantly, it was a post hoc exploratory analysis, and prospective assessments will be required to confirm the value of repeat application of the capsaicin 179 mg cutaneous patch in patients who do not respond to the first cycle of treatment. The analysis was “as treated,” and only patients who received at least one application were included. Missing data from patients who withdrew from the studies could not be accounted for, and this is a study limitation. In this analysis, there were no comparative data, and hence there was no way to determine which improvements were due to therapy and which were attributable to other factors, such as the Hawthorne effect  , naturalIn a subgroup analysis of an open-label trial designed to study the tolerability of multiple treatments of the capsaicin 179 mg cutaneous patch over 52 weeks, patients were divided in subgroups according to the duration of NeP since diagnosis . That anIt is logical that patients who did not respond early might have started other pain medications, and this is a potential confounding factor. However, in STRIDE, there were no patients among the responder groups who started using gabapentin/pregabalin after baseline; in PACE, there were only four such patients. Use of these pain medications thus is not likely to have confounded the results. With regard to opioids, some patients started opioids, but others stopped taking them, which suggests that, for certain patients, the capsaicin 179 mg cutaneous patch provided an opioid-sparing effect. If opioid initiation were a significant confounder, we would expect the net change in opioid use to be greater in the groups of patients who responded late (after the second or third application) than in the patients who responded early. In STRIDE, the net change in opioid use in patients who responded to the first, second, and third application was +4 (+6.7%), +2 (+6.1%), and +4 (36.3%) patients, respectively. In PACE, the net change in opioid use in patients who responded to the first, second, and third application was +4 (+4.2%), +5 (+7.4%), and +1 (2.3%) patients, respectively. Given the apparent similarity of the net change in opioid use among the responder groups , 30, we It is not clear why discontinuations were more common in STRIDE than in PACE. However, it is possible that there was less incentive to remain in STRIDE because patients were able to access the treatment outside the trial, as the NeP types included in STRIDE were within the approved indication at the time.Some patients experience rapid and long-lasting improvements in pain after a single local treatment of peripheral NeP with the capsaicin 179 mg cutaneous patch, whereas others may follow a more progressive or incremental course of benefit in terms of pain, sleep, QOL, and patient satisfaction. In the latter individuals, two or even three treatments ≥8 weeks apart are needed before a response is achieved. Slower responders appear to “catch up” with rapid responders over time. Repeat treatment may therefore be important to maximize efficacy in those who do not initially respond.The capsaicin 179 mg cutaneous patch was also generally well tolerated and was associated with low levels of discontinuations due to adverse events in all subgroups studied.The potential mechanisms underlying progressive responses to the capsaicin 179 mg cutaneous patch are not fully understood, but they may relate to disease modification through “pruning” of abnormal nerve fibers, followed by regeneration of more normal fibers , and thi


Summary of Background Data. The pain intensity (PI) reduction is a parameter of surgical treatment efficacy. The two most commonly used scales of PI are NRS and VAS. Many studies have shown strong similarities between those two scales, but the direct interchange is difficult.  To compare the viability of the numerical rating scale (NRS) and the visual analogue scale (VAS) as a pain assessment tools among a large cohort of patients who underwent microdiscectomy.  Patients, who underwent microdiscectomy, were prospectively enrolled into the study and assessed using VAS and NRS for the back (NRS-B) and the leg (NRS-L), Short Form of McGill Pain Questionnaire (SF-MPQ) included Pain Rating Index (PRI) and Oswestry Disability Index (ODI) 1 day before and 1 month and 3 months after the procedure. p < 0.001) 1 month after microdiscectomy. NRS-L and NRS-B ratings remained at a similar level while VAS and ODI decreased after 3 months. The rate of decline of PI measured by NRS-L correlated statistically significant  with ODI 1 month after surgery. Before surgery, the most significant correlation was found between ODI and NRS-L , the lowest with NRS-B . 3 months after surgery, there was higher correlations between ODI and VAS (rs = 0.634) than NRS-L (rs = 0.265). PRI correlated significantly (p < 0.001) and more stronger with VAS than with NRS-L and NRS-B in every points of assessment.  131 patients were included in the study. NRS-L, NRS-B, VAS, and ODI were significantly lower  but in different modes . NRS and VAS are not parallel scales and assess different aspects of pain. The measurement of NRS-L 1 month after microdiscectomy seems to give quick insight into the effectiveness of the procedure. Reliable assessment of discectomy results in patients with low back pain (LBP) and lumbar radicular pain (LRP) still remains a challenge. An evaluative endpoint of such treatment is not defined. The evaluation of LBP/LRP treatment effects is still difficult due to insufficient outcome parameters used . In manyPhysiotherapy in 1980 [Functional disability is another value to consider evaluating endpoint surgery outcome. The Oswestry Disability Index (ODI) derived from the self-reported Oswestry Low Back Pain Questionnaire was used to quantify disability for LBP and is considered as a “functional scale.” The patient is asked to assess how the leg and back pain affects nine, daily activities. It is important to remember that the first question concerns measuring PI by the necessity of painkillers usage. This validated questionnaire was first published by Fairbank et al. in  in 1980 . The cur in 1980 , and it  in 1980 , and it  in 1980 . An ODI  in 1980 .The aim of this study was to assess and compare NRS and VAS in the group of patients who underwent discectomy as a treatment of pharmacologically refractory LRP/LBP. Their correlations with ODI and also with Short Form of McGill Pain Questionnaire (SF-MPQ) and Beck Depression Inventory (BDI) can define their properties. The results of our study can be helpful in determining the most accurate and useful tools to monitor and evaluate treatments effects in this group of patients.131  patients with LBP and/or LRP admitted to the Department of Neurosurgery of the Medical University of Lublin were prospectively enrolled into the study. They were qualified to microdiscectomy. All patients received written and verbal information regarding study procedures as well as sign an informed consent. In accordance with binding legislation in this field, the Ethics Committee of the Medical University of Lublin in Poland approved the protocol as well as the details of the informed consent.M = 38.95, SD = 11.23). 80 (61.1%) had a job requiring hard physical activity. Duration of pain was between 1 and 144 months  before surgical treatment.The patients mean age ranged from 18 to 76 (The inclusion criteria for microdiscectomy were as follows: (1) the age of patients between 18 and 80 years, (2) the diagnosis of clinically symptomatic disc herniation (DH), (3) the confirmation of clinical diagnosis by magnetic resonance imaging (MRI), and (4) persistent pain and lack of conservative treatment effects. The exclusion criteria were as follows: (1) previous corticosteroid therapy during three months preceding surgery, (2) previous spine surgery or spinal stenosis, and (3) coexistence of other medical conditions such as rheumatoid diseases, diabetes, cancer, psychiatric disorders, recent surgery for reason other than DH, pregnancy, and alcohol or drug abuse.All patients were operated on by the same surgeon who used the standard microdiscectomy method on a single DH level. The procedure was carried out under general anaesthesia.All patients were assessed according to NRS in the back (NRS-B) and the leg (NRS-L) as well as VAS, SF-MPQ, ODI, and BDI, separately. The subjects were evaluated a day before operation and subsequently one and three months following the procedure by the same investigator.NRS: the patient is asked to indicate the value of his pain on the scale. A 11-point scale was used, with “0” representing “no pain” and “10” representing the “most severe pain imaginable” at the time of assessment.VAS: it is assessed on a 100 mm horizontal line. The patient is informed that the left end of the scale represents “no pain” and that the right end represents the “most severe pain imaginable.” The patient is then instructed to mark PI currently being experienced on the line.ODI: the patient is asked to assess how his leg and back pain affects nine activities: personal care, lifting, walking, sitting, standing, sleeping, employment/homemaking, traveling, and social life. The answer for the first question values PI according to the necessity of painkiller intake. Each answer is scored from 0 to 5. Based on the total score, which ranges from 0 to 50, it is possible to evaluate disability for LBP as minimal, moderate, severe, crippling back pain, or disability which makes the patient bed-bound.SF-MPQ: it consists of the Pain Rating Index (PRI), Present Pain Intensity (PPI), and VAS. For PRI, the patient is asked to describe the sensory and affective qualities of his experience. Descriptors are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate, or 3 = severe. PRI is the sum of the intensity values of descriptors which characterize pain. PPI is a six steps scale rating PI, from 0 (“no pain”) to 5 (“excruciating pain”).BDI (Beck Depression Inventory): the patient is asked to answer 21 questions regarding his mood. Every answer is rated from 0 to 4. The presence and intensity of depressive disturbances are evaluated against total score.U test. Fridman's rank test and Wilcoxon signed-rank test were used to compare the dependent groups. Significance values have been adjusted by Bonferroni correction for multiple tests. Kendall's W coefficient was used to estimate the effect size. The correlation coefficient of Spearman's rho was employed to assess the associations between variables. The level of significance was α = 0.05.Statistical analysis was performed with the use of the IBM SPSS Statistics  software for Windows . The mean and standard deviation values for descriptive analysis were provided. Before comparative analyzes were carried out, all data sets had been tested for normal distribution by Kolmogorov–Smirnov test. Statistical differences between nondependent groups were calculated using the nonparametric Mann–Whitney p < 0.001) 1 month after discectomy. NRS-L, NRS-B, and PPI scores remained stable while ODI (p < 0.001), VAS (p=0.018), and PRI (p=0.016) scores decreased 3 months after surgery. However, the most significant decrease in PI was recorded in NRS-L (W = 0.78)  .rs = 0.527) and NRS-L (rs = 0.494), the lowest with NRS-B (rs = 0.319) results. Increased PI correlates with a greater degree of disability.Correlations of NRS-L, NRS-B, VAS, PRI, and PPI scores with ODI score before surgery: significant correlations between every scale of pain assessment results and ODI score were observed. The highest correlation with ODI score was observed with PPI (rs = 0.599), PPI (rs = 0.584), and VAS (rs = 0.560) scores and the weaker between NRS-B (rs = 0.361) and especially NRS-L (rs = 0.354) with ODI score were observed. 3 months after surgery, the strength of correlations between ODI with PRI (rs = 0.722), PPI (rs = 0.742), VAS (rs = 0.634), and NRS-B (rs = 0.418) scores increased but with NRS-L (rs = 0.265) score decreased  and ODI . There were no significant correlations between pain scale scores and pain duration. Comparisons of PI between men and women showed no significant differences except that the PI assessed by PPI was significantly higher in the female's group .Correlations of NRS-L, NRS-B, VAS, ODI, PRI, and PPI scores with age and pain duration before surgery. The age of patients correlates significantly with VAS (rs = 0.366) was found between results of NRS-L and ODI , 1 , and 3  months after surgery . 53% of patients had no signs of depression (BDI < 10). With the remainder, the intensity of depression had a significant and moderate correlation with ODI score , mild with PRI (rs = 0.251), NRS-L (rs = 0.210 p < 0.016), and PPI  as well as no significant correlation with NRS-B scores and VAS scores  and NRS current .The choice of pain scales to evaluate the effects of microdiscectomy should depend on time of assessment.In summary, based on results of our study, VAS evaluates the pain not only in aspects of its intensity but also in its character and its affective perception by an individual as a complex experience in the recent time while NRS assessed the pain in aspects of its intensity in current time.Because of the complexity of pain, the multidimensional approach to objective assessment is recommended . In 2015Differences in PI assessment by NRS and VAS indicate prompt necessity of more objective tools for evaluation of pain, e.g., biochemical markers.Our study is limited by inadequate assessment of quality of life and BMI. Pain is a complex biopsychosocial experience which affects quality of life. We consider that additional data on quality of life and correlation with results of VAS and NRS with BMI  could be valuable and enriching for the discussion.


Pain-related , as well as psychological outcome domains , were investigated. The results support the short-term and long-term efficacy of IIPT for pediatric chronic headache patients regarding the pain-related outcome measures by significant reductions from PRE to all follow-up measure points. For anxiety and depression, only short-term improvements were found. Future studies should specifically focus on the identification of methods to consolidate the beneficial short-term effects of IIPT on psychological outcome domains in the long term.Pediatric chronic headache causes significant impairment to those affected and bears the risk of aggravation into adulthood. Intensive interdisciplinary pain treatment (IIPT) was found to positively affect pain-related and emotional outcomes in pediatric patients with chronic pain up to 4 years after treatment. This study was aimed at investigating the effect of IIPT on solely pediatric chronic headache patients. As part of a longitudinal observation study,  Severe chronic pain in children and adolescents is a highly impairing health condition, not only for the 5% to 8% of children severely affected ,2, but aFindings of numerous studies demonstrate that intensive interdisciplinary pain treatment (IIPT) represents a short-term as well as a long-term effective treatment for pediatric patients with severely disabling chronic pain ,7. In thn = 135 pediatric patients with chronic headache receiving IIPT between 2008 and 2014. They demonstrated a significant linear improvement in pain-related and psychological parameters, such as daily and family functioning as well as school absence. The drop-out rate in this study was very high (87.4%). In a retrospective study with a convenience sample of n = 50 headache patients, Shulman et al. [However, while numerous studies have investigated the usefulness of IIPT for children with chronic pain and functional disability ,10, few n et al.  also shoThis prospective longitudinal observational study aims to provide further evidence for the short-term effectiveness of IIPT for pediatric chronic headache patients and to investigate the long-term utility of IIPT for this patient group over 4 years.The study was initially implemented as a larger randomized controlled trial (RCT) with a wait-list control condition. The patients on the waitlist received the same IIPT after a short time delay of 3–4 weeks. Therefore, the group comparison of the RCT was conducted when the intervention group finished their 3–4-week inpatient treatment and the control group was about to start their inpatient treatment. Because after this time point both groups had received the same treatment, the study was then transferred into a longitudinal observation design . LongituPatients were eligible for the study if they (1) presented at the German Pediatric Pain Centre during the recruitment period (November 2009–July 2011); (2) fulfilled a priori-defined criteria for the admission to IIPT (3) were between 9 and 17 years old; (4) had age-appropriate German language and reading comprehension; and (5) they and their parents agreed to participate in the study. Criteria for admission to IIPT were: (1) no malignant disease, (2) age-appropriate comprehension of German, (3) severe pain-related disability, and (4) motivation for therapy judged by a clinician during the initial appointment. Moreover, three of the following five requirements had to be met: (1) pain duration ≥ six months, (2) average pain intensity of ≥5 over the preceding seven days on a 0 to 10 Numeric Rating Scale (NRS), (3) pain peaks (pain intensity ≥8) occurring more than twice per week, (4) a minimum of one week absent from school due to pain within the preceding four weeks, and (5) high pain disability as perceived by the adolescent (P-PDI ≥ 36) . Study en = 70 children who reported headache as their main pain location were eligible.Children and adolescents were referred to the pain center by their primary care pediatricians. Study participants were recruited for the study by a researcher at the initial appointment (PRE) at the pain center. For this subsample analysis with chronic headache, a total of n = 65 participated in the 6-MONTH FOLLOW-UP, n = 58 in the 1-YEAR FOLLOW-UP, and n = 47 participated in the 4-YEAR FOLLOW-UP. The study flowchart for this analysis is depicted in Of these, At admission, no significant differences were found between participants who participated in the follow-ups and those who refused to participate in the follow-ups regarding demographic characteristics , pain parameters , or psychological characteristics .At the initial appointment at the pain center (PRE), the patients completed the study questionnaires. Six months (6-MONTH FOLLOW-UP), as well as one year after the initial appointment (1-YEAR FOLLOW-UP), both study groups received the questionnaires via mail and were asked to return them to the pain center. The long-term follow-up assessment four years after enrollment (4-YEAR FOLLOW-UP) was implemented (1) through a structured 30-min telephone interview by trained student research assistants and (2) additional paper-pencil questionnaires. This procedure differing from the other two assessment points was chosen to inform and remind the patients verbally about the study, to check their mailing address, and to collect item data (primarily core pain characteristics). Furthermore, the phone call aimed to increase the study participation rate. After the interview, the study participants were asked if they were willing to complete further questionnaires containing more complex items regarding psychological outcome domains (see ‘Measures’ for details). These were sent to them via mail. Pain-related parameters were assessed within the interviews, while data on psychological outcome measures were collected via the questionnaires.The IIPT followed a manualized treatment approach  providedThe average pain intensity within the past seven days was reported by the patients on a numerical rating scale (NRS) ranging from 0 to 10 (0 = no pain to 10 = strongest pain). This assessment method is valid and sensitive to change in pediatric samples .Patients were asked to report the number of days they had missed school due to pain within the last four weeks (maximum of 20 days).Pain-related disability was assessed via the validated Paediatric Pain Disability Inventory (PPDI) ,17, whicGeneral anxiety was measured using the validated Anxiety Questionnaire for Pupils (AFS) . This meDepression was assessed using the validated Depression Inventory for Children and Adolescents (DIKJ) 2000 . This 26The study procedure was approved by the ethics committee of Witten/Herdecke University (Nr. 78/2007). Moreover, it was registered in the “German Clinical Trials Register”  and the ISRCTN register .® software (release 27.0 for Windows®). The following statistics were used:All data analyses were carried out with SPSSFirst, the demographic and clinical characteristics of the sample at PRE were described by the use of descriptive statistics (mean (M) and standard deviation (SD) for continuous variables; frequencies and percentages for categorical variables). Equivalence of the group of responders and non-responders at 4-YEAR FOLLOW-UP was established by testing for differences in these variables between the two groups .For the longitudinal analyses, repeated measures analyses of variance (ANOVA) with four assessment time points  were used to examine the influence of time on changes on each of the continuous dependent variables . The Greenhouse-Geisser adjustment was used to correct for violations of sphericity. In the case of a detected significance, Bonferroni-adjusted post hoc analyses were applied to locate the significant change.n = 70 children and adolescents with chronic headaches. Study participants were on average 14.5 years old (SD = 2.11) and 77.1% of them were female. All patients were diagnosed with the main diagnosis of a somatoform or chronic pain disorder (ICD-10 F45.40 or F45.41). Secondary diagnoses were migraine in 41% and tension-type headache in 19% of the sample. The demographic and clinical characteristics at PRE of the total study subsample and the group of participants, as well as dropouts of the subsample at 4-YEAR FOLLOW-UP, are depicted in n = 47 patients had data available.The total study subsample was composed of As shown in p < 0.001, partial η2 = 0.41) and pain intensity  = 18.34, p < 0.001, partial η2 = 0.31) differed significantly between assessment time points. Post hoc tests using the Bonferroni correction revealed that both parameters were significantly reduced compared to PRE at 6-MONTH FOLLOW-UP (both p < 0.001), 1-YEAR FOLLOW-UP (both p < 0.001) as well as at 4-YEAR FOLLOW-UP (both p < 0.001). There were no significant changes in pain-related disability  or in pain intensity  between the follow-up time points.A repeated measures ANOVA determined that pain-related disability  = 27.52, p < 0.001, partial η2 = 0.47) differed significantly between assessment time points. Bonferroni-adjusted post hoc analyses detected that school absence was significantly reduced compared to PRE at 6-MONTH FOLLOW-UP (p < 0.001), 1-YEAR FOLLOW-UP (p < 0.001), as well as at 4-YEAR FOLLOW-UP (p < 0.001).Moreover, a repeated-measures ANOVA with Greenhouse-Geisser correction determined that missed school days  = 28.26, p = 0.003, partial η2 = 0.18). Bonferroni-corrected post hoc tests revealed a significant reduction from PRE to 6-MONTH FOLLOW-UP (p < 0.001) and from PRE to 1-YEAR FOLLOW-UP (p = 0.006), but not from PRE to 4-YEAR FOLLOW-UP (p = 0.077). There were no other significant changes in depression between the follow-ups .A repeated-measures ANOVA with Greenhouse-Geisser correction detected a significant difference between assessment time points for depression  = 6.47, p = 0.003, partial η2 = 0.15). Bonferroni-corrected post hoc tests revealed a significant reduction from PRE to 6-MONTH FOLLOW-UP (p = 0.001), but not from PRE to 1-YEAR FOLLOW-UP (p = 0.066) or from PRE to 4-YEAR FOLLOW-UP (p = 0.222). Again, there were no other significant changes in anxiety between the follow-ups .Concurrently, a repeated-measures ANOVA showed a significant difference in anxiety between assessment time points  = 5.11, This longitudinal observational study aimed to investigate the short- and long-term effects of pediatric IIPT for patients with chronic headache. The six-month follow-up data demonstrated that short-term improvement was found in all pain-related and psychological parameters; patients suffered from less intense pain and less pain-related disability, while they attended school more frequently and indicated lower levels of depression and anxiety. Regarding the long-term effects of IIPT, there was a beneficial decline in pain-related outcome parameters; four years after IIPT, patients again reported less pain-related disability, pain intensity, and school absence. However, no significant long-term treatment effects of IIPT on anxiety and depression could be detected. Furthermore, the outcome parameters did not improve between the follow-ups, indicating that the effects of IIPT mostly kick in within the first year after treatment.The findings of this study are in line with previous research on the effectiveness of pediatric IIPT. Shulman et al.  also fouDespite the positive findings regarding the short- and long-term treatment effects of IIPT on pain-related parameters in children and adolescents with chronic headache, the improvements in general anxiety and depression were not replicated in our study. Although data still suggests a remarkable decrease in general anxiety and depression levels from admission to four years after discharge, the trend for improvement was not significant over this period. This corresponds with findings in previous research, which found no long-term effects of IIPT on anxiety and depression in pediatric patients with various pain complaints . One posThere are several limitations to consider when interpreting these results and to attend to for future research. Even though the attrition rate after four years was an acceptable 33% and the drop-out analyses did not show any baseline differences between responders and drop-outs, systematic bias cannot be eliminated. Future research should therefore strongly focus on ways to increase participation adherence in longitudinal studies. Moreover, in this longitudinal observation study, a natural remission is not controlled for. Previous research indicated that a natural remission might especially be likely in males . FurtherThe current longitudinal observation study found distinct evidence for the short- and long-term effectiveness of IIPT for children and adolescents with chronic headaches. This intensive and specified therapy approach positively affected pain-related outcomes in the short- and long-term, as well as psychological outcomes in the short-term. Future research is required to identify methods to consolidate the beneficial effects of IIPT on psychological outcome domains in the long-term.


What is the utility of using a patient-reported outcome measure to assess chronic pain?In this cross-sectional study of 31 600 patients, 32.5% screened positive for chronic pain with use of a tool comprising a single-question assessment of pain frequency, followed by a 3-question functional assessment . Of these patients, 43.9% had not received a diagnosis for a chronic painful condition and 59.1% reported severe pain interference with activities of daily living.The findings of this study suggest that implementing this measure for chronic pain screening and functional assessment might provide additional clinical information on patients’ pain experience. Although pain is among the most common symptoms reported by patients, primary care practitioners (PCPs) face substantial challenges identifying and assessing pain.To evaluate a 2-step process for chronic pain screening and follow-up in primary care.A cross-sectional study of patients with a primary care visit between July 2, 2018, and June 1, 2019, was conducted at a statewide, multisite federally qualified health center. Participants included 68 PCPs and 58 medical assistants from 13 sites who implemented the screening process in primary care, and 38 866 patients aged 18 years or older with a primary care visit during that time.Single-question assessment of pain frequency, followed by a 3-question PEG  functional assessment for patients with chronic pain.Adherence to a 2-step chronic pain screening and PEG process, proportion of patients with positive screening results, mean PEG pain severity greater than or equal to 7, and documented chronic painful condition diagnosis in patient’s electronic health record between 1 year before and 90 days after screening.Of 38 866 patients with a primary care visit, 31 600 patients (81.3%) underwent screening. Mean (SD) age was 46.2 (15.4) years, and most were aged 35 to 54 years (12 987 [41.1%]), female (18 436 [58.3%]), Hispanic (14 809 [46.9%]), and English-speaking (22 519 [71.3%]), and had Medicaid insurance (18 442 [58.4%]). A total of 10 262 participants (32.5%) screened positive and, of these, 9701 (94.5%) completed the PEG questionnaire. PEG responses indicated severe pain interference with activities of daily living (PEG ≥7) in 5735 (59.1%) participants. A chronic painful condition had not been diagnosed in 4257 (43.9%) patients in the year before screening. A new chronic painful condition was diagnosed at screening or within 90 days in 2250 (52.9%) patients. Care teams found the workflow acceptable, but cited lengthy administration time, challenges with comprehension of the PEG questions, and limited comprehensiveness as implementation barriers.A systematic, 2-step process for chronic pain screening and functional assessment in primary care appeared to identify patients with previously undocumented chronic pain and was feasible to implement. Patient-provided information on the frequency of pain, pain level, and pain interference can help improve the assessment and monitoring of pain in primary care. This cross-sectional study evaluated a 2-item tool used to assess patients’ pain and its interference with activities of daily living in a primary care setting. PROM tools, such as the PEG, examine health status and health-related quality of life from patients’ perspectives and allow health care professionals to more systematically incorporate patients’ experiences and preferences into their treatment plan.30 There is limited information on the best approaches for incorporating pain functional assessment in primary care,32 and available information26 may not be generalizable to safety-net practices such as FQHCs. The objective of this study was to evaluate the implementation of a 2-step process in a large, multisite FQHC to screen for chronic pain and assess its association with function as reported by patients.Although the 11-point Numeric Rating Scale pain score is widely used to assess pain, this approach has limitationsThis cross-sectional observational study was conducted at a statewide, multisite FQHC in Connecticut providing medical, behavioral health, and dental care to approximately 100 000 patients, most of whom are members of racial/ethnic minority groups, have income less than 200% of the federal poverty level, and reside in urban or suburban areas. Patients were empaneled and cared for by primary care teams consisting of primary care practitioners (PCPs) , medical assistants (MAs), nurses, and colocated behavioral health professionals.STROBE) reporting guideline for observational cross-sectional studies.The Community Health Center Inc and Advarra institutional review boards reviewed and approved the study protocol. The institutional review boards granted a waiver of consent for analysis of data extracted from medical records and for observation of clinic operations. Professionals provided verbal informed consent for interviews; no financial compensation was provided. This study followed the Strengthening the Reporting of Observational Studies in Epidemiology  or via webinar. A custom clinical decision support dashboard prompted MAs to screen all adult patients for chronic pain annually. If a patient had screened positive within the past year and had not completed PEG within the past 90 days, the MA was prompted to administer it. MAs entered patient responses into an electronic data collection smart form in the electronic health record; the responses were stored as part of the patient’s record and were visible to the PCP for discussion during the visit  thereafter, until the patient screened negative for chronic pain at subsequent annual chronic pain screening. An average PEG response of greater than or equal to 7  was considered severe pain interference.35 Age, sex, self-reported race/ethnicity, primary insurance, and preferred language were extracted from the electronic health record, corresponding to hypothesized association with potential pain disparities.We used a validated, single-question chronic pain screening tool: “In the past 3 months, how often did you have pain?” Answer choices were never, some days, most days, every day, and don’t know. Responses of most days or every day were considered a positive screening indicator for chronic pain.The parent study’s project advisory panel of academic pain specialists, frontline clinical professionals, epidemiologists, and health services researchers developed a consensus list of diagnoses associated with painful conditions . P values were adjusted for multiple comparisons using the Holm method; owing to a large sample size, the α level was set to .01 and effect size was measured using the Cramer V statistic. We analyzed qualitative data from key informant interviews using content analysis in NVivo, version 16 .We conducted bivariate statistical analyses using χA total of 31 600 patients (81.3% of those with a visit) were screened for chronic pain with the new 2-step process; mean (SD) age was 46.2 (15.4) years and most were aged 35 to 54 years (12 987 [41.1%]), female (18 436 [58.3%]), Hispanic (14 809 [46.9%]), and English-speaking (22 519 [71.3%]), and had Medicaid insurance (18 442 [58.4%]). A total of 13 164 (41.7%) men were included. Of patients assessed, 10 262 (32.5%) screened positive for chronic pain, and 9701 (94.5%) with positive screening results completed PEG functional assessment .P < .001) and weakly associated with race/ethnicity , insurance , preferred language  (P < .001) (Most patients who screened positive for chronic pain were aged 35 to 54 years (4674 [45.5%]) , female (6176 [60.2%]), Hispanic (4228 [41.2%]), and English-speaking (8193 [79.8%]), and had Medicaid insurance (6367 [62.0%]). Screening results were moderately associated with age  , and the < .001) .P < .001). Of 19 875 patients without a documented chronic painful condition diagnosis in the year before screening, 4485 (22.6%) screened positive for chronic pain; 2370 (52.8%) of these patients received a new pain diagnosis on the date of their positive screen or within 90 days and 2115 (47.2%)  did not .Of the 9701 patients who completed PEG , 5735 5. All of Workflow observations and interviews identified clinical decision support, time, comprehension, and attitudes about normalizing pain as key themes. Using the clinical decision support dashboard helped facilitate integration of the new process into existing workflows. The MAs initially found it difficult to break the ingrained habit of recording a pain score at every visit in favor of this new 2-step process. PCPs shared concerns about chronic pain screening and PEG results, including “adding a new complaint” that was “usually not part of the [complaint] that the patient is visiting to discuss.”The PCPs and MAs noted that asking about pain often elicited long responses. An MA stated that “some patients want to give me their life history of pain, and I have to keep reminding them to answer the question”; a PCP commented that, “even when the reason for visit is not pain related, many patients report that they are in pain when asked [and want to discuss it].”Some patients were unfamiliar with the concept of pain interference and “[did] not understand the PEG questions without examples,” requiring MAs to “break down and simplify” questions to elicit a response. The MAs reported that even after they offered explanations of enjoyment of life and general activity, patients sometimes gave the same numeric response to chronic pain screening and to each PEG question or responded that “[they had] already told [me] their pain was an 8.” One MA speculated that patients may have assumed a higher score would lead to more or better treatment, remarking that “[I have to tell patients that since] we are trying to see whether or not their pain has improved, giving a high score [that does not reflect their actual pain] might mean we stop treatment that’s been working.”The PCPs believed that the new process increased the need to rediscuss and readdress pain. A PCP noted that “[our] tepid response [to the new process] may be due to pain fatigue—we don’t know what else we can do to treat patients’ pain.” A PCP in a leadership role stated that reframing the discussion about pain would benefit patients and health care professionals, stating that “[though] we have created a culture where we speak about pain a lot, this changes the focus to what really matters: whether pain interferes with activity.”We used a 2-step screening process to detect chronic pain and assessed its use in a large population of medically underserved patients receiving care in an FQHC. The new process appeared to improve PCPs’ insight into pain interference and pain severity and trigger PCPs to focus on functional assessment.7 In contrast to the National Health Interview Survey, which reported an increasing prevalence of chronic pain with age and higher prevalence of chronic pain among non-Hispanic White adults, we found no significant differences based on race or ethnicity and only a moderate association between chronic pain and patient age. It may be that in this population of vulnerable, medically underserved patients, race, ethnicity, and age interact with socioeconomic factors and other social determinants of health that extend across racial and ethnic groups.1 Further studies should examine the extent of this association.Approximately one-third (32.5%) of patients in this sample of low-income, urban/suburban, racial and ethnic minority patients screened positive for chronic pain, exceeding the estimated rates of chronic pain in the general population (20%) and in urban areas (16.4%) reported in the 2019 National Health Interview Survey.36 About half of the patients with a documented pain diagnosis on the date of screening screened positive for chronic pain and half screened negative. A negative screening result may have indicated that pain was well controlled or that the condition was no longer active or causing pain. Future research should examine the medical records of patients who screened negative for chronic pain, despite the presence of a chronic painful condition diagnosis in their medical record within the past year, to assess potential associations with diagnosis and treatment history.We hypothesized that replacing the use of a 0- to 10-level pain scale at each visit with an annual screening for chronic pain combined with patient self-report of pain frequency and pain interference would improve clinicians’ ability to identify, assess, and monitor chronic pain. Patients’ responses provided clinically useful information that assisted PCPs in detecting and addressing chronic pain. We observed an association between positive vs negative screening results and the presence of an existing pain diagnosis in the year before screening, consistent with earlier studies suggesting that diagnostic codes alone are not useful in differentiating chronic pain from acute or episodic pain.Similarly, 4485 patients (43.7%) with a positive chronic pain screen did not have a previously documented pain diagnosis. The fact that nearly half of them received a new pain diagnosis suggests that the screening process was not simply confirming what was already known to the PCP but rather was flagging issues that may not have been recognized or discussed previously. We were not able to examine whether the 0- to 10-point pain analog scale scores that had been previously recorded were aligned with patients’ self-report of pain most days or every day and their responses to PEG questions about pain intensity and interference with enjoyment of life and general activity. This factor could be a focus of future work.7 The high prevalence of severe pain detected by this new process confirms the importance of establishing a systematic method for screening and following up on chronic pain.Augmenting chronic pain screening with PEG helped clinicians identify pain that patients reported as having negative implications in their lives. Nearly 60% of patients who completed PEG reported severe pain interference, far exceeding the National Health Interview Survey estimate of 7.4% of adults in the general population whose pain had frequently limited activities of daily living.International Classification of Diseases, Version 11 aim to address this coding gap by including diagnosis codes for classification of chronic pain38 and providing options to document both chronic primary pain  and chronic secondary pain .38A significant number of patients who screened positive for chronic pain did not have a documented painful condition diagnosis before screening, nor did they receive one after screening positive (2115 [20.6%]). There are several potential explanations for this lack of diagnosis. Pain, unlike many other chronic conditions, is affected by a range of biopsychosocial factors. Pain may be present without a clear anatomical cause. Our code list for painful conditions did not include psychosocial factors, such as stress, depression, anxiety, or trauma, which are known to affect the pain experience and may result in a report of chronic pain without a pain-specific diagnosis or code. The pain diagnosis guidelines recommended by the International Association for the Study of Pain for the 39 determining what needs to be addressed requires negotiation and balance between what the PCP believes is essential and what the patient wants to discuss. Although adding the chronic pain screen to the routine clinic workflow increased visit complexity, this increase is an inevitable consequence of adding any new screening process in primary care. Clinicians’ frustration and dissatisfaction with having to readdress and rediscuss pain is an understandable consequence of a health care delivery system that is still based largely on short in-person visits and high-volume, fee-for-service encounters. New payment models are needed that reward clinicians both for providing evidence-based care and understanding and supporting person-centeredness. In addition, tools that help patients prepare for their visits in advance and take an active role in setting the agenda may help clinicians better address patients’ most pressing needs within limited visit times.Given that the average primary care visit in the US is between 15 and 20 minutes,Using a team-based approach that included MAs was necessary to successful implementation. MAs are typically responsible for data collection and screening and were able to incorporate this new screening process into their existing patient intake process. Familiar clinical decision support tools further facilitated successful implementation.This study had limitations. We conducted the study at a practice with sophisticated electronic health record data reporting and modification capabilities, which may not be representative of the resources available in all safety-net primary care practices. Other limitations include its focus on a primary care population at a single FQHC, which may not be representative of primary care patients in other settings, and limited ability to assess reasons for nonadherence to the screening protocol or examine patients’ medical records in detail to explain discordance between their screening responses and clinicians’ documentation of a chronic painful condition. Future research should examine patients’ perceptions of this chronic pain screening and functional assessment process to ascertain whether patients feel that pain interference is an important and relevant aspect of their pain and whether they perceive the new process as beneficial to their care.This study has implications for primary care. Chronic pain is underdiagnosed and undertreated. We presented a simple, 2-step screening and functional assessment process that might be successfully implemented across a large safety-net practice. The process resulted in the identification of previously undocumented chronic pain conditions and used a PROM tool that helped to engage patients and set the stage for a more patient-centered encounter.