Ultrasound-guided percutaneous electrical nerve stimulation versus surgery for women with unilateral carpal tunnel syndrome: A randomized parallel-group trial.

OBJECTIVE: The aim of this clinical trial was to compare the outcomes of the application of ultrasound-guided percutaneous nerve stimulation (PENS) targeting the median nerve versus surgery for improving pain and function in women with CTS. METHODS: In this randomized parallel-group trial (ClinicalTrials.gov, NCT04246216), 70 women with CTS were randomly allocated to either PENS (n = 35) or surgery (n = 35) group. Hand pain intensity (mean pain and the worst pain experienced) was the primary outcome. Functional status and symptoms severity (Boston Carpal Tunnel Questionnaire, BCTQ) and self-perceived improvement (Global Rating of Change, GROC) were the secondary outcomes. Outcomes were assessed at baseline and 1, 3, 6 and 12 months after each intervention. Analysis was performed with intention to treat with mixed ANCOVAs adjusted for baseline outcomes. RESULTS: Analyses showed an adjusted advantage for PENS at 1 (Δ -2.0, 95% CI -2.9 to -1.1) and 3 (Δ -1.4, 95% CI -2.3 to -0.5) months for mean pain, at 1 (Δ -2.2, 95% CI -3.3 to -1.1), 3 (Δ -1.75, 95% CI -2.9 to -0.6) and 6 (Δ -1.7, 95% CI -2.8 to -0.6) months in the worst pain intensity, and at 1 (Δ -0.95, 95% CI -1.1 to -0.8), 3 (Δ -0.55, 95% CI -0.8 to -0.3) and 6 (Δ -0.4, 95% CI -0.6 to -0.8) months in function. Both groups exhibited similar changes in symptom severity. Both groups reported similar improvement at 12 months in all outcomes. Symptoms and function improved in both groups, with PENS leading to better short-term outcomes than surgery. CONCLUSION: This clinical trial confirms that PENS applied with current understanding of pain mechanisms in CTS is as useful as surgery in women with CTS without denervation. The potential placebo effect of both interventions should not be ignored. SIGNIFICANCE: The application of percutaneous nerve stimulation was more effective at short-term, but similar effective at mid and long-term, than surgery in women with carpal tunnel syndrome.

Manual Therapy Versus Surgery for Carpal Tunnel Syndrome: 4-Year Follow-Up From a Randomized Controlled Trial.

OBJECTIVE: No study to our knowledge has investigated the effects longer than 1 year of manual therapy in carpal tunnel syndrome (CTS). The purpose of this study was to investigate the effects of manual therapy versus surgery at 4-year follow-up and to compare the post-study surgery rate in CTS. METHODS: This randomized controlled trial was conducted in a tertiary public hospital and included 120 women with CTS who were randomly allocated to manual therapy or surgery. The participants received 3 sessions of physical therapy, including desensitization maneuvers of the central nervous system or carpal tunnel release combined with a tendon/nerve gliding exercise program at home. Primary outcome was pain intensity (mean and the worst pain). Secondary outcomes included functional status, symptom severity, and self-perceived improvement measured using a global rating of change scale. Outcomes for this analysis were assessed at baseline, 1 year, and 4 years. The rate of surgical intervention received by each group was assessed throughout the study. RESULTS: At 4 years, 97 (81%) women completed the study. Between-group changes for all outcomes were not significantly different at 1 year (mean pain: mean difference [MD] = -0.3, 95% CI = -0.9 to 0.3; worst pain: MD = -1.2, 95% CI = -3.6 to 1.2; function: MD = -0.1, 95% CI = -0.4 to 0.2; symptom severity: MD = -0.1, 95% CI = -0.3 to 0.1) and 4 years (mean pain: MD = 0.1, 95% CI = -0.2 to 0.4; worst pain: MD = 0.2, 95% CI = -0.8 to 1.2; function: MD = 0.1, 95% CI = -0.1 to 0.3; symptom severity: MD = 0.2, 95% CI = -0.2 to 0.6). Self-perceived improvement was also similar in both groups. No between-group differences (15% physical therapy vs 13% surgery) in surgery rate were observed during the 4 years. CONCLUSIONS: In the long term, manual therapy, including desensitization maneuvers of the central nervous system, resulted in similar outcomes and similar surgery rates compared with surgery in women with CTS. Both interventions were combined with a tendon/nerve gliding exercise program at home. IMPACT: This is the first study to our knowledge to report clinical outcomes and surgical rates during a 4-year follow-up and will inform decisions regarding surgical versus conservative management of CTS. LAY SUMMARY: Women with CTS may receive similar benefit from a more conservative treatment-manual therapy-as they would from surgery.

Cost-Effectiveness Evaluation of Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: Evidence From a Randomized Clinical Trial.

BACKGROUND: Carpal tunnel syndrome (CTS) results in substantial societal costs and can be treated either by nonsurgical or surgical approaches. OBJECTIVE: To evaluate differences in cost-effectiveness of manual physical therapy versus surgery in women with CTS. METHODS: In this randomized clinical trial, 120 women with a clinical and an electromyographic diagnosis of CTS were randomized through concealed allocation to either manual physical therapy or surgery. Interventions consisted of 3 sessions of manual physical therapy, including desensitization maneuvers of the central nervous system, or decompression/release of the carpal tunnel. Societal costs and health-related quality of life (estimated by the European Quality of Life-5 Dimensions [EQ-5D] scale) over 1 year were used to generate incremental cost per quality-adjusted life year ratios for each treatment. RESULTS: The analysis was possible for 118 patients (98%). Incremental quality-adjusted life years showed greater cost-effectiveness in favor of manual physical therapy (difference, 0.135; 95% confidence interval: 0.134, 0.136). Manual therapy was significantly less costly than surgery (mean difference in cost per patient, €2576; P<.001). Patients in the surgical group received a greater number of other treatments and made more visits to medical doctors than those receiving manual physical therapy (P = .02). Absenteeism from paid work was significantly higher in the surgery group (P<.001). The major contributors to societal costs were the treatment protocol (surgery versus manual therapy mean difference, €106 980) and absenteeism from paid work (surgery versus manual physical therapy mean difference, €42 224). CONCLUSION: Manual physical therapy, including desensitization maneuvers of the central nervous system, has been found to be equally effective but less costly (ie, more cost-effective) than surgery for women with CTS. From a cost-benefit perspective, the proposed CTS manual physical therapy intervention can be considered. LEVEL OF EVIDENCE: Economic and decision analyses, level 1b. J Orthop Sports Phys Ther 2019;49(2):55-63. Epub 30 Nov 2018. doi:10.2519/jospt.2019.8483.

The Effectiveness of Manual Therapy Versus Surgery on Self-reported Function, Cervical Range of Motion, and Pinch Grip Force in Carpal Tunnel Syndrome: A Randomized Clinical Trial.

Study Design Randomized parallel-group trial. Background Carpal tunnel syndrome (CTS) is a common pain condition that can be managed surgically or conservatively. Objective To compare the effectiveness of manual therapy versus surgery for improving self-reported function, cervical range of motion, and pinch-tip grip force in women with CTS. Methods In this randomized clinical trial, 100 women with CTS were randomly allocated to either a manual therapy (n = 50) or a surgery (n = 50) group. The primary outcome was self-rated hand function, assessed with the Boston Carpal Tunnel Questionnaire. Secondary outcomes included active cervical range of motion, pinch-tip grip force, and the symptom severity subscale of the Boston Carpal Tunnel Questionnaire. Patients were assessed at baseline and 1, 3, 6, and 12 months after the last treatment by an assessor unaware of group assignment. Analysis was by intention to treat, with mixed analyses of covariance adjusted for baseline scores. Results At 12 months, 94 women completed the follow-up. Analyses showed statistically significant differences in favor of manual therapy at 1 month for self-reported function (mean change, -0.8; 95% confidence interval [CI]: -1.1, -0.5) and pinch-tip grip force on the symptomatic side (thumb-index finger: mean change, 2.0; 95% CI: 1.1, 2.9 and thumb-little finger: mean change, 1.0; 95% CI: 0.5, 1.5). Improvements in self-reported function and pinch grip force were similar between the groups at 3, 6, and 12 months. Both groups reported improvements in symptom severity that were not significantly different at all follow-up periods. No significant changes were observed in pinch-tip grip force on the less symptomatic side and in cervical range of motion in either group. Conclusion Manual therapy and surgery had similar effectiveness for improving self-reported function, symptom severity, and pinch-tip grip force on the symptomatic hand in women with CTS. Neither manual therapy nor surgery resulted in changes in cervical range of motion. Level of Evidence Therapy, level 1b. Prospectively registered September 3, 2014 at www.clinicaltrials.gov (NCT02233660). J Orthop Sports Phys Ther 2017;47(3):151-161. Epub 3 Feb 2017. doi:10.2519/jospt.2017.7090.

Prediction of Outcome in Women With Carpal Tunnel Syndrome Who Receive Manual Physical Therapy Interventions: A Validation Study.

Study Design Secondary analysis of a randomized trial. Background A clinical prediction rule to identify patients with carpal tunnel syndrome (CTS) most likely to respond to manual physical therapy has been published but requires further testing to determine its validity. Objective To assess the validity of a clinical prediction rule proposed for the management of patients with CTS in a different group of patients with a variety of treating clinicians. Methods A preplanned secondary analysis of a randomized controlled trial investigating the efficacy of manual physical therapies, including desensitization maneuvers of the central nervous system, in 120 women suffering from CTS was performed. Patients were randomized to receive 3 sessions of manual physical therapy (n = 60) or surgical release/decompression of the carpal tunnel (n = 60). Self-perceived improvement with a global rating of change was recorded at 6- and 12-month follow-ups. Pain intensity (mean pain and worst pain on a 0-to-10 numeric pain-rating scale) and scores on the Boston Carpal Tunnel Questionnaire (functional status and symptom severity subscales) were assessed at baseline and at 1, 3, 6, and 12 months. A baseline assessment of status on the clinical prediction rule was performed (positive status on the clinical prediction rule was defined as meeting at least 2 of the following criteria: pressure pain threshold of less than 137 kPa over the affected C5-6 joint; heat pain threshold of less than 39.6°C over the affected carpal tunnel; and general health score [Medical Outcomes Study 36-Item Short-Form Health Survey] of greater than 66 points). Linear mixed models with repeated measures were used to examine the validity of the rule. Results Participants with a positive status on the rule who received manual physical therapy did not experience greater improvements compared to those with a negative status on the rule for mean pain (P = .65), worst pain (P = .86), function (P = .99), or symptom severity (P = .85). Further, the clinical prediction rule performed no better than chance in identifying the individuals with CTS most likely to respond to manual physical therapy or surgery (mean pain, P = .87; worst pain, P = .91; function, P = .60; severity, P = .66). No differences in self-perceived improvement were observed at either 6 (P = .68) or 12 (P = .36) months, according to the rule. Conclusion The results of this study did not support the validity of the previously developed clinical prediction rule for manual physical therapy in women with CTS. Level of Evidence Prognosis, level 1b. J Orthop Sports Phys Ther 2016;46(6):443-451. Epub 23 Mar 2016. doi:10.2519/jospt.2016.6348.

Manual Physical Therapy Versus Surgery for Carpal Tunnel Syndrome: A Randomized Parallel-Group Trial.

UNLABELLED: This randomized clinical trial investigated the effectiveness of surgery compared with physical therapy consisting of manual therapies including desensitization maneuvers in carpal tunnel syndrome (CTS). The setting was a public hospital and 2 physical therapy practices in Madrid, Spain. One hundred twenty women with CTS were enrolled between February 2013 and January 2014, with 1-year follow-up completed in January 2015. Interventions consisted of 3 sessions of manual therapies including desensitization maneuvers of the central nervous system (physical therapy group, n = 60) or decompression/release of the carpal tunnel (surgical group, n = 60). The primary outcome was pain intensity (mean pain and the worst pain), and secondary outcomes included functional status and symptoms severity subscales of the Boston Carpal Tunnel Questionnaire and the self-perceived improvement. They were assessed at baseline and 1, 3, 6, and 12 months by a blinded assessor. Analysis was by intention to treat. At 12 months, 111 (92%) women completed the follow-up (55/60 physical therapy, 56/60 surgery). Adjusted analyses showed an advantage (all, P < .01) for physical therapy at 1 and 3 months in mean pain (Δ -2.0 [95% confidence interval (CI) -2.8 to -1.2]/-1.3 [95% CI -2.1 to -.6]), the worst pain (Δ -2.9 [-4.0 to -2.0]/-2.0 [-3.0 to -.9]), and function (Δ -.8 [-1.0 to -.6]/-.3 [-.5 to -.1]), respectively. Changes in pain and function were similar between the groups at 6 and 12 months. The 2 groups had similar improvements in the symptoms severity subscale of the Boston Carpal Tunnel Questionnaire at all follow-ups. In women with CTS, physical therapy may result in similar outcomes on pain and function to surgery. TRIAL REGISTRATION: http://www.clinicaltrials.gov, ClinicalTrials.gov, NCT01789645. PERSPECTIVE: This study found that surgery and physical manual therapies including desensitization maneuvers of the central nervous system were similarly effective at medium-term and long-term follow-ups for improving pain and function but that physical therapy led to better outcomes in the short term.