Efficacy of botulinum toxin type A for treatment of persistent myofascial TMD pain: a randomized, controlled, double-blind multicenter study

Evidence of an effect by botulinum toxins is still lacking for most pain conditions. In the present randomized, placebo-controlled, crossover multicenter study, the efficacy of botulinum toxin type A (BTX-A) was investigated in patients with persistent myofascial temporomandibular disorders (TMD). Twenty-one patients with myofascial TMD without adequate pain relief after conventional treatment participated. A total of 50 U of BTX-A or isotonic saline (control) was randomly injected into 3 standardized sites of the painful masseter muscles. Follow-up was performed after 1 and 3 months, followed by a 1-month washout period, after which crossover occurred. Pain intensity at rest was the primary outcome measure, while physical and emotional function, global improvement, side effects, and clinical measures were additional outcome measures. There was no main difference between drugs (ANOVA; P = .163), but there was a significant time effect (P < .001), so BTX-A reduced mean (SD) percent change of pain intensity by 30 (33%) after 1 month and by 23 (30%) after 3 months compared to 11 (40%) and 4 (33%) for saline. The number of patients who received a 30% pain reduction was not significantly larger for BTX-A than after saline at any follow-up visit. The number needed to treat was 11 after 1 month and 7 after 3 months. There were no significant changes after treatment in any other outcome measures, with the exception of pain on palpation, which decreased 3 months after saline injection (P < .05). These results do not indicate a clinical relevant effect of BTX-A in patients with persistent myofascial TMD pain.     

Far-infrared ray patches relieve pain and improve skin sensitivity in myofascial pain syndrome: A double-blind randomized controlled study

ObjectiveMyofascial pain syndrome (MPS) is a common disorder characterized by muscle pain if myofascial trigger points (MTrP) are stimulated. This study evaluated the effectiveness of far-infrared ray (FIR) patches in reducing the severity of pain in patients with MPS.MethodsA double-blind, randomized controlled study involving 125 patients with MPS and 201 MTrPs located in the trapezius muscle. A FIR patch was applied to 98 MTrPs for 24 h in the intervention group (61 patients) and a placebo patch was applied to 91 MTrPs in the control group (57 patients) at the end. Pain intensity was measured using the visual analogue scale (V) while pressure pain threshold (P) and maximal pain tolerance (T) were measured using an algometer before and after treatment.ResultsThe mean age of the patients was 37.16 years old and 67% were female. There was a positive correlation between P and T (p < 0.001). Older Age was associated with higher P and T due to poor skin sensitivity (p < 0.001). V improved significantly in both groups to a similar extent, but only in the intervention group, P and T decreased significantly (which implied better skin sensitivity) (p < 0.05). P and T decreased the most in the female group aged over 35, probably due to thinner skin in this subgroup.ConclusionsFIR and placebo patches were equally effective at relieving pain (with decreased V), but P and T dropped only in the intervention group with FIR patches. This probably resulted from FIR penetrated only to the skin layer and improved skin sensitivity with more blood circulation, but the muscle remained unaffected. Further studies should investigate the effect of longer exposure or higher energy applications.     

Mindfulness meditation for the treatment of chronic low back pain in older adults: a randomized controlled pilot study

The objectives of this pilot study were to assess the feasibility of recruitment and adherence to an eight-session mindfulness meditation program for community-dwelling older adults with chronic low back pain (CLBP) and to develop initial estimates of treatment effects. It was designed as a randomized, controlled clinical trial. Participants were 37 community-dwelling older adults aged 65 years and older with CLBP of moderate intensity occurring daily or almost every day. Participants were randomized to an 8-week mindfulness-based meditation program or to a wait-list control group. Baseline, 8-week and 3-month follow-up measures of pain, physical function, and quality of life were assessed. Eighty-nine older adults were screened and 37 found to be eligible and randomized within a 6-month period. The mean age of the sample was 74.9 years, 21/37 (57%) of participants were female and 33/37 (89%) were white. At the end of the intervention 30/37 (81%) participants completed 8-week assessments. Average class attendance of the intervention arm was 6.7 out of 8. They meditated an average of 4.3 days a week and the average minutes per day was 31.6. Compared to the control group, the intervention group displayed significant improvement in the Chronic Pain Acceptance Questionnaire Total Score and Activities Engagement subscale (P=.008, P=.004) and SF-36 Physical Function (P=.03). An 8-week mindfulness-based meditation program is feasible for older adults with CLBP. The program may lead to improvement in pain acceptance and physical function.     

The efficacy of traction for back pain: a systematic review of randomized controlled trials

OBJECTIVE: To assess the efficacy of traction for patients with low back pain (LBP) with or without radiating pain, taking into account the clinical technique or parameters used. DATA SOURCES: A computer-aided search of MEDLINE, CINAHL, AMED, and the Cochrane Collaboration was conducted for randomized controlled trials (RCTs) in the English language, from 1966 to December 2001. STUDY SELECTION: RCTs were included if: participants were over the age of 18 years, with LBP with or without radiating pain; the intervention group received traction as the main or sole treatment; the comparison group received sham traction or another conservative treatment; and the study used 1 of 4 primary outcome measures. DATA EXTRACTION: The study was conducted in 2 strands. Strand 1 assessed methodologic quality using a specific criteria list recommended by the Cochrane Back Review Group. The strength of the evidence was then rated using the Agency for Health Care Policy and Research system. Strand 2 applied further inclusion criteria based on recommended clinical parameters. One reviewer conducted the selection and data extraction. DATA SYNTHESIS: Strand 1: 1 study scored 9 points (maximum score, 10 points); the other 12 scored between 0 and 3 points, indicating that most were of poor quality. Nine studies reported negative findings, but only 1 study was of a high quality. Three studies reported positive findings and 1 study was inconclusive. Strand 2: only 4 trials having low methodologic quality were included, 2 of which reported negative findings, and 2 positive findings. CONCLUSION: The evidence for the use of traction in LBP remains inconclusive because of the continued lack of methodologic rigor and the limited application of clinical parameters as used in clinical practice. Further trials, which give attention to these areas, are needed before any firm conclusions and recommendations may be made.     

A prospective, randomised trial of immediate exercise following lumbar microdiscectomy: a preliminary study

Objective

To investigate whether immediate commencement of exercises after lumbar microdiscectomy enabled patients to become independently mobile more rapidly with no increase in risk of complications.

Study design

Randomised, single-blind, controlled trial.

Setting

One secondary care teaching hospital in the UK.

Participants

Thirty patients were recruited. The follow-up rate was 28 (93%) at 4 weeks and 23 (77%) at 3 months.

Interventions

Patients were randomised to an intervention group commencing exercises within 2 hours after surgery, or a control group commencing exercises on the first postoperative day.

Main outcome measures

Primary outcome measures included the time taken for the patient to become independently mobile and attain discharge criteria following surgery. Secondary outcome measures were disability and pain scores collected before surgery, and 4 weeks and 3 months after surgery; and return to work rates.

Results

The two groups were similar at baseline. The results indicated significantly reduced time to independent mobility [median 7 vs 19 hours, median difference 9 hours, 95% confidence interval (CI) 1.25 to 14.5, P = 0.009] and return to work (median 6 vs 8 weeks, median difference 2 weeks, 95% CI 0 to 6, P = 0.002) in the intervention group compared with the control group. At 15 hours after surgery, independent mobility was attained in 80 and 40% of the intervention and control groups, respectively. There were no significant differences in disability and pain scores at 4 weeks and 3 months.

Conclusions

Immediate commencement of exercises following first-time single-level lumbar microdiscectomy enabled patients to become independently mobile more rapidly and return to work sooner. Immediate commencement of exercises may enable patients to be discharged earlier, with associated cost benefits to health care and no increase in the rate of revision surgery.     

Gabapentin in traumatic nerve injury pain: a randomized, double-blind, placebo-controlled, cross-over, multi-center study

A double-blind, randomized, placebo-controlled cross-over multi-center study was conducted to evaluate the efficacy and safety of gabapentin in the treatment of neuropathic pain caused by traumatic or postsurgical peripheral nerve injury, using doses up to 2400 mg/day. The study comprised a run-in period of two weeks, two treatment periods of five weeks separated by a three weeks’ washout period. The primary efficacy variable was the change in the mean pain intensity score from baseline to the last week of treatment. Other variables included pain relief, health related quality of life (SF-36), interference of sleep by pain, Clinician and Patient Global Impression of Change, and adverse effects. Nine centers randomized a total of 120 patients, 22 of whom withdrew. There was no statistically significant difference between the treatments for the primary outcome efficacy variable. However, gabapentin provided significantly better pain relief (p = 0.015) compared with placebo. More patients had at least a 30% pain reduction with gabapentin compared with placebo (p = 0.040) and pain interfered significantly less with sleep during gabapentin treatment compared with placebo (p = 0.0016). Both the Patient (p = 0.023) and Clinician (p = 0.037) Global Impression of Change indicated a better response with gabapentin compared with placebo. Gabapentin was well tolerated. The most common adverse effects were dizziness and tiredness.     

Predicting outcome of TENS in chronic pain: a prospective, randomized, placebo controlled trial

Transcutaneous electrical nerve stimulation (TENS) is an easy to use non-invasive analgesic intervention applied for diverse pain states. However, effects in man are still inconclusive, especially for chronic pain. Therefore, to explore the factors predicting result of TENS treatment in chronic pain we conducted a prospective, randomized, placebo-controlled trial (n = 163), comparing high frequency TENS (n = 81) with sham TENS (n = 82). Patients’ satisfaction (willingness to continue treatment; yes or no) and pain intensity (VAS) were used as outcome measures. The origin of pain and cognitive coping strategies were evaluated as possible predictors for result of TENS treatment. Results: Fifty-eight percent of the patients in the TENS group and 42.7% of the sham-TENS group were satisfied with treatment result (chi square = 3.8, p = 0.05). No differences were found for pain intensity. Patients diagnosed with osteoarthritis and related disorders (especially of the vertebral column) or peripheral neuropathic pain were less satisfied with high frequency TENS (OR = 0.12 (95% CI 0.04–0.43) and 0.06 (95% CI 0.006–0.67), respectively). Injury of bone and soft tissue (especially postsurgical pain disorder) provided the best results. Treatment modality or interactions with treatment modality did not predict intensity of pain as a result of treatment. We conclude, that predicting the effect of high frequency TENS in chronic pain depends on the choice of outcome measure. Predicting patients’ satisfaction with treatment result is related to the origin of pain. Predicting pain intensity reflects mechanisms of pain behavior and perceived control of pain, independent of treatment modality. Pain catastrophizing did not predict TENS treatment outcome.     

Continuous intra-articular infusion of bupivacaine for post-operative pain relief after total hip arthroplasty: A randomized,placebo-controlled,double-blind study

BackgroundInstillation of local anesthetics into a surgical site has been gaining popularity in post-operative pain management.AimTo determine whether continuous intra-articular infusion of bupivacaine via pain-control infusion pumps (PCIP) enhances and sustains analgesia after total hip arthroplasty (THA).MethodsNinety-two patients undergoing THA were randomized to receive continuous intra-articular infusion of either 0.5% bupivacaine or 0.9% normal saline at a flow rate of 2 mL/h via a PCIP for 48 h. The primary outcome measure was pain intensity on Visual Analogue Scale (VAS) scores in the first 72 h. Other measures included time to first rescue dose of narcotics, amount of narcotic use, presence of adverse events, length of hospital stay, and hip function evaluated with the Western Ontario and McMaster Universities Osteoarthritis (WOMAC) index.ResultsDespite a longer time to first narcotic rescue (56 versus 21 min, p < 0.0001) in patients receiving bupivacaine, the two groups did not differ significantly in overall pain relief (p = 0.54). A lower VAS score was found only at time 0 and 2 h; no difference in VAS score was noted at any other time point. Additionally, no difference was found in terms of amount of narcotic use, incidence of adverse events, hospitalization days, and the WOMAC score.ConclusionContinuous intra-articular infusion of 0.5% bupivacaine at 2 mL/h via a PCIP does not provide sustained post-operative pain relief in patients undergoing THA.     

Short- and long-term efficacy of brief cognitive-behavioral therapy for patients with chronic temporomandibular disorder pain: a randomized, controlled trial

We evaluated the short- and long-term efficacy of a brief cognitive-behavioral therapy (CBT) for chronic temporomandibular disorder (TMD) pain in a randomized controlled trial. TMD clinic patients were assigned randomly to four sessions of either CBT (n=79) or an education/attention control condition (n=79). Participants completed outcome (pain, activity interference, jaw function, and depression) and process (pain beliefs, catastrophizing, and coping) measures before randomization, and 3 (post-treatment), 6, and 12 months later. As compared with the control group, the CBT group showed significantly greater improvement across the follow-ups on each outcome, belief, and catastrophizing measure (intent-to-treat analyses). The CBT group also showed a greater increase in use of relaxation techniques to cope with pain, but not in use of other coping strategies assessed. On the primary outcome measure, activity interference, the proportion of patients who reported no interference at 12 months was nearly three times higher in the CBT group (35%) than in the control group (13%) (P=0.004). In addition, more CBT than control group patients had clinically meaningful improvement in pain intensity (50% versus 29% showed > or =50% decrease, P=0.01), masticatory jaw function (P<0.001), and depression (P=0.016) at 12 months (intent-to-treat analyses). The two groups improved equivalently on a measure of TMD knowledge. A brief CBT intervention improves one-year clinical outcomes of TMD clinic patients and these effects appear to result from specific ingredients of the CBT.     

A physiotherapist-led exercise and education program for preventing recurrence of low back pain: a randomised controlled pilot trial

Background

Before beginning a large and complex trial it is considered good practice to run a pilot study to assess the feasibility and acceptability so that quality is maintained and resources are not wasted.

Kinesio Taping for pain control during labor: Protocol of a randomized,controlled trial

This study protocol will evaluate the effectiveness and safety during labor and delivery of the Kinesio Taping bandage for pain sensation, satisfaction of patients, and obstetric and neonatal outcomes. A randomized controlled trial with 60 participants divided into two groups will be conducted. The intervention group will receive bandage application on the vertebral regions corresponding to uterine dermatomes – from T10 to L1 and from S2 to S4. The control group will receive bandage application away from uterine dermatomes, from T1 to T4. The primary endpoint is pain during labor. Secondary endpoints are perinatal outcomes and patient satisfaction with the bandage and with her labor. Pain levels will be evaluated on an hourly basis during labor, and intention‐to‐treat analysis will be performed. Risk ratios and 95% confidence intervals will be calculated. Findings on effectiveness of pain control with no adverse effects to both the mother and neonate are the first step in evaluating the systematic use of Kinesio Taping during labor. Since self‐control may affect birthing experience satisfaction, discovering new alternatives for pain control may allow for a better experience.     

The preliminary effect of a parenting program for Korean American mothers: a randomized controlled experimental study

BACKGROUND: Traditional Korean American discipline is characterized by a lack of expression of affection and use of harsh discipline. OBJECTIVE: The purpose of this study was to pilot test the effect of the Incredible Years Parenting Program among Korean American mothers. METHODS: A randomized controlled experimental study design was used; 29 first-generation Korean American mothers of young children (3-8 years old) were randomly assigned to intervention (n=20) and control (n=9) groups. Intervention group mothers received a 12-week parenting program. Control group mothers did not receive the intervention. Mothers reported on discipline styles (positive, appropriate, and harsh), level of acculturation, and their child's outcomes (behavioral problems and social competence) at pre-, post-, and 1-year follow-up intervals. RESULTS: After completing the program, intervention group mothers significantly increased use of positive discipline as compared to control group mothers. Among intervention group mothers, high-acculturated mothers significantly increased appropriate discipline whereas low-acculturated mothers significantly decreased harsh discipline. In the 1-year follow-up, intervention group mothers maintained the significant effect for positive discipline. CONCLUSIONS: Providing this program appears to be a promising way of promoting positive discipline among Korean American mothers.     

The added value of cognitive behavioral therapy for insomnia to current best evidence physical therapy for chronic spinal pain: protocol of a randomized controlled clinical trial

Background

Insomnia is a highly prevalent and debilitating comorbidity that is often not addressed in therapy for chronic spinal pain (CSP). Given the close interaction between insomnia and CSP severity and related disability, targeting sleep problems during therapy could improve treatment outcomes in these patients.

Preventing shoulder pain after cardiac rhythm management device implantation: a randomized, controlled study

Introduction: Shoulder pain and disability ipsilateral to the implant site is a common complication of cardiac rhythm device implantation, yet very little has been published about this morbidity. We designed a study to assess the potential benefit of a simple exercise protocol in preventing shoulder pain postoperatively. Methods and Results: Patients undergoing subcutaneous device implantation were randomized to one of two groups. The control group received standard instructions, whereas the exercise group was instructed on specific exercises aimed at strengthening or stretching the shoulder girdle, to be completed 3 days per week. Groups were postoperatively monitored for the development of shoulder discomfort and shoulder impingement by using physical examination and disability questionnaires. At 1 month, seven of 21 control patients reported developing shoulder pain or discomfort compared to one of 23 in the exercise group (P = 0.02). At 6 months, four of 23 control patients still reported worsening shoulder symptoms, compared to none in the exercise group (P = 0.11). In the control group, five of 19 patients developed a positive impingement test at 1 month, versus none in the exercise group (P = 0.01). Scores for the questionnaires designed to assess shoulder pain and dysfunction were worse in the control group. There were no activity‐related complications in either group. Conclusion: Shoulder pain and disability occurs often following cardiac rhythm management device implantation. A simple exercise program aimed at strengthening the shoulder girdle is effective at preventing this complication. (PACE 2011; 672–678)     

Self‐management of persistent neck pain: A randomized controlled trial of a multi‐component group intervention in primary health care

Studies regarding self‐management of persistent neck pain are infrequent. Objective: to compare treatment effects of (a) a multi‐component pain and stress self‐management group intervention (PASS) and (b) individually administered physical therapy (IAPT) for patients with persistent musculoskeletal tension‐type neck pain. Methods: Persons seeking physical therapy treatment due to persistent tension‐type neck pain at nine primary health care centers in Sweden were randomly assigned to either PASS or IAPT. Before treatment (baseline) and at 10‐ and 20‐weeks the participants completed a self‐assessment questionnaire comprising: the Self‐Efficacy Scale, the Neck Disability Index, the Coping Strategies Questionnaire, the Hospital Anxiety and Depression Scale, the Fear‐Avoidance Beliefs Questionnaire and questions regarding neck pain, analgesics and utilization of health care. Intention‐to‐treat analyses were performed using repeated measures analysis of variance between baseline, 10‐week and 20‐week follow‐up. Results: One hundred and fifty six participants were included (PASS n = 77, IAPT n = 79). On average participants receiving PASS attended seven treatment sessions and participants receiving IAPT 11 sessions over the 20‐week follow‐up period. Repeated measures ANCOVA showed significant time × group interaction effects for ability to control pain , self‐efficacy regarding pain‐interfering activities , disability due to neck pain (p = 0.001) and levels of catastrophic thinking in favour of PASS. Conclusion: PASS had a better effect than IAPT in the treatment of persistent musculoskeletal tension‐type neck pain regarding coping with pain, in terms of patients’ self‐reported pain control, self‐efficacy, disability and catastrophizing, over the 20‐week follow‐up.     

Non-rigid lumbar supports for the management of non-specific low back pain: A literature review and meta-analysis

BackgroundClinical practice guidelines for non-specific low back pain do not recommend the use of non-rigid lumbar supports (NRLSs) despite the publication of several positive randomized controlled studies.ObjectiveWe conducted a systematic review with meta-analysis to assess the efficacy of NRLSs in the treatment and prevention of non-specific low back pain.MethodsWe searched for reports of randomized controlled trials in PubMed, Cochrane Library, EMBASE, Science Direct and Pedro databases. Data were analyzed by disease stage (acute, subacute, and chronic) and type of prevention (primary and secondary). The analysis of methodological quality involved the Physiotherapy Evidence Database (PEDro) scale.ResultsOf the 1581 records retrieved, only 4 full-text articles were included, with 777 patients: 378 in the NRLS group, and 348 in the control group. NRLSs conferred greater amelioration of disability (effect size ?0.54, 95% CI ?0.90; ?0.17) and pain (?0.29, ?0.46; ?0.12) than standard management. Insufficient data prevented a comparison of the efficiency for acute, subacute and recurrent low back pain as well as meta-regression of responder phenotypes (sociodemographic and other patient characteristics).ConclusionWe demonstrated the overall efficacy of NRLSs for both disability and pain. However, further studies are needed to assess which patients can benefit the most from lumbar supports based on patient phenotype and the characteristics of low back pain.PROSPERO (CRD42018109855).     

Thoracic sympathetic block for the treatment of complex regional pain syndrome type I: A double-blind randomized controlled study

Pain relief in complex regional pain syndrome (CRPS) remains a major challenge, in part due to the lack of evidence-based treatment trials specific for this condition. We performed a long-term randomized, double-blinded active-control study to evaluate the efficacy of thoracic sympathetic block (TSB) for upper limb type I CRPS. The study objective was to evaluate the analgesic effect of TSB in CRPS. Patients with CRPS type I were treated with standardized pharmacological and physical therapy and were randomized to either TSB or control procedure as an add-on treatment. Clinical data, pain intensity, and interference (Brief Pain Inventory), pain dimensions (McGill Pain Questionnaire [MPQ]), neuropathic characteristics (Neuropathic Pain Symptom Inventory [NPSI]), mood, upper limb function (Disabilities of Arm, Shoulder and Hand), and quality of life were assessed before, and at 1 month and 12 months after the procedure. Thirty-six patients (19 female, 44.7 ± 11.1 years of age) underwent the procedure (17 in the TSB group). Average pain intensity at 1 month was not significantly different after TSB (3.5 ± 3.2) compared to control procedure (4.8 ± 2.7; P = 0.249). At 12 months, however, the average pain item was significantly lower in the TSB group (3.47 ± 3.5) compared to the control group (5.86 ± 2.9; P = 0.046). Scores from the MPQ, evoked-pain symptoms subscores (NPSI), and depression scores (Hospital Anxiety and Depression Scale) were significantly lower in the TSB group compared to the control group at 1 and at 12 months. Other measurements were not influenced by the treatment. Quality of life was only slightly improved by TSB. No major adverse events occurred. Larger, multicentric trials should be performed to confirm these original findings.     

Results of a randomized controlled trial to examine the efficacy of a chronic pain self-management group for older adults [ISRCTN11899548

Chronic pain is a common, disabling problem in older adults. Pain self-management training is a multimodal therapy that has been found to be effective in young to middle-aged adult samples; however, few studies have examined the effectiveness of this therapy in older adults. In this randomized, controlled trial, we evaluated a pain self-management training group (SMG) intervention as compared with an education-only (BOOK) control condition. Participants, 65 years of age or older who experienced persistent, noncancer pain that limited their activities, were recruited from 43 retirement communities in the Pacific Northwest of the United States. The primary outcome was physical disability, as measured by the Roland-Morris Disability Questionnaire. Secondary outcomes were depression (Geriatric Depression Scale), pain intensity (Brief Pain Inventory), and pain-related interference with activities (Brief Pain Inventory). Randomization occurred by facility to minimize cross-contamination between groups. Two-hundred and fifty-six individuals, mean age = 81.8 (SD: 6.5), enrolled and 218 completed the study. No significant differences in outcomes were found between groups at post-intervention, 6-month follow-up, or 12-month follow-up. The SMG group showed a significantly greater increase over time, relative to the BOOK group, in two process measures, as measured by the Chronic Pain Coping Inventory: use of relaxation and use of exercise/stretching. In both cases, the increase was greatest from baseline to the post-intervention assessment. Study findings indicate that additional research is needed to determine the most effective content and delivery methods for self-management therapies targeted at older adults with chronic pain.     

Daily repetitive transcranial magnetic stimulation of primary motor cortex for neuropathic pain: A randomized,multicenter, double-blind,crossover, sham-controlled trial

There is little evidence for multisession repetitive transcranial magnetic stimulation (rTMS) on pain relief in patients with neuropathic pain (NP), although single-session rTMS was suggested to provide transient pain relief in NP patients. We aimed to assess the efficacy and safety of 10 daily rTMS in NP patients. We conducted a randomized, double-blind, sham-controlled, crossover study at 7 centers. Seventy NP patients were randomly assigned to 2 groups. A series of 10 daily 5-Hz rTMS (500 pulses/session) of primary motor cortex (M1) or sham stimulation was applied to each patient with a follow-up of 17 days. The primary outcome was short-term pain relief assessed using a visual analogue scale (VAS). The secondary outcomes were short-term change in the short form of the McGill pain questionnaire (SF-MPQ), cumulative changes in the following scores (VAS, SF-MPQ, the Patient Global Impression of Change scale [PGIC], and the Beck Depression Inventory [BDI]), and the incidence of adverse events. Analysis was by intention to treat. This trial is registered with the University hospital Medical Information Network Clinical Trials Registry. Sixty-four NP patients were included in the intention-to-treat analysis. The real rTMS, compared with the sham, showed significant short-term improvements in VAS and SF-MPQ scores without a carry-over effect. PGIC scores were significantly better in real rTMS compared with sham during the period with daily rTMS. There were no significant cumulative improvements in VAS, SF-MPQ, and BDI. No serious adverse events were observed. Our findings demonstrate that daily high-frequency rTMS of M1 is tolerable and transiently provides modest pain relief in NP patients.