Author Names
Fernández-de-Las-Peñas C, Arias-Buría JL, Cleland JA, Pareja JA, Plaza-Manzano G, Ortega-Santiago R
Reviewer Name
Erin Dennis, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
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. Trial registration: ClinicalTrials.gov NCT01789645. Keywords: Carpal Tunnel; Physical Therapy; Surgery.
NIH Risk of Bias Tool
Quality Assessment of Controlled Intervention Studies
- Was the study described as randomized, a randomized trial, a randomized clinical trial, or an RCT
- Yes
- Was the method of randomization adequate (i.e., use of randomly generated assignment)?
- Yes
- Was the treatment allocation concealed (so that assignments could not be predicted)?
- Yes
- Were study participants and providers blinded to treatment group assignment?
- No
- Were the people assessing the outcomes blinded to the participants’ group assignments?
- Yes
- Were the groups similar at baseline on important characteristics that could affect outcomes (e.g., demographics, risk factors, co-morbid conditions)?
- Yes
- Was the overall drop-out rate from the study at endpoint 20% or lower of the number allocated to treatment?
- Yes
- Was the differential drop-out rate (between treatment groups) at endpoint 15 percentage points or lower?
- Yes
- Was there high adherence to the intervention protocols for each treatment group?
- Yes
- Were other interventions avoided or similar in the groups (e.g., similar background treatments)?
- Yes
- Were outcomes assessed using valid and reliable measures, implemented consistently across all study participants?
- Yes
- Did the authors report that the sample size was sufficiently large to be able to detect a difference in the main outcome between groups with at least 80% power?
- Yes
- Were outcomes reported or subgroups analyzed prespecified (i.e., identified before analyses were conducted)?
- Yes
- Were all randomized participants analyzed in the group to which they were originally assigned, i.e., did they use an intention-to-treat analysis?
- Yes
Key Finding #1
There were no significant differences between those who received manual therapy versus surgery in mean pain, worst pain, and self-perception of improvement at 1- and 4-years post-intervention.
Key Finding #2
Only 15% of women who received manual therapy required surgery 4 years post-intervention compared to previous findings suggesting a surgery rate of 60% after localized conservative treatment.
Key Finding #3
The proposed manual therapy approach including soft tissue mobilizations and nerve/tendon gliding techniques directed at the entire upper extremity may be more effective than localized interventions targeting only the hand and/or wrist in the CTS population based on current nociceptive theories on CTS.
Please provide your summary of the paper
The results of this study revealed similar outcomes 4 years post-treatment in women with carpal tunnel syndrome who received manual therapy consisting of desensitization maneuvers of the central nervous system versus those who received surgery combined with a tendon and nerve gliding home exercise program. Data on mean pain, worst pain, functional status, and self-perceived improvements were collected at baseline, 1, 3, and 6 months, and 1 and 4 years after treatment. The authors found no significant differences in these outcomes at the 1- and 4-year follow-ups. While only the manual therapy group received soft tissue mobilization, both the manual therapy group and the surgical intervention group were instructed in a tendon/nerve gliding exercise program, which could influence the 1- and 4-year follow-up outcomes. Other limitations of this study include the lack of accounting for psychological variables, such as mood disorders or sleep disturbances, the fact that patients nor clinicians were blinded to the treatment intervention due to the nature of the treatments, and the lack of reassessing provocative tests (i.e. Phalen or Tinel test) nor electromyography at any period, which could also elucidate potential between-group differences. The authors discussed a need for future research to identify what types of patients may benefit from conservative management as the first therapeutic option compared to those who would best benefit from surgery.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
The results of this study can assist clinicians with patient education and advocating for conservative therapy as the first therapeutic intervention in women with carpal tunnel syndrome. Since the outcomes were similar in the manual therapy and surgical groups at 1 and 4 years post-intervention, conservative therapy should be advocated for in this patient population to avoid the higher risk of complications that may come with surgery. The authors found that only 15% of the women who received manual therapy required surgery 4 years after the intervention, which is contrary to previous findings suggesting a surgery rate of 60% after localized conservative treatment. These results should guide clinicians to utilize similar manual therapy techniques, which included soft tissue mobilizations and nerve/tendon gliding techniques directed at the entire upper extremity according to more current nociceptive theories on CTS compared to previous more localized therapeutic approaches targeting solely the hand and/or wrist.
