Author Names
Fernández-de-las-Peñas, C., PT, PhD, DMSc; Cleland, J., PT, PhD, OCS, FAAOMPT; Palacios-Ceña, M., PT; Fuensalida-Novo, S., PT; Pareja, J., MD, PhD; Alonso-Blanco, C., PT, PhD
Reviewer Name
Jordan Jaklic, SPT
Reviewer Affiliation(s)
Duke University School of Medicine, Doctor of Physical Therapy Division
Paper Abstract
Abstract
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
NIH Risk of Bias Tool
Quality Assessment Tool for Before-After (Pre-Post) Studies With No Control Group
- Was the study question or objective clearly stated?
- Yes
- Were eligibility/selection criteria for the study population prespecified and clearly described?
- Yes
- Were the participants in the study representative of those who would be eligible for the test/service/intervention in the general or clinical population of interest?
- No
- Were all eligible participants that met the prespecified entry criteria enrolled?
- Yes
- Was the sample size sufficiently large to provide confidence in the findings?
- Cannot Determine, Not Reported, Not Applicable
- Was the test/service/intervention clearly described and delivered consistently across the study population?
- Yes
- Were the outcome measures prespecified, clearly defined, valid, reliable, and assessed consistently across all study participants?
- Yes
- Were the people assessing the outcomes blinded to the participants’ exposures/interventions?
- Yes
- Was the loss to follow-up after baseline 20% or less? Were those lost to follow-up accounted for in the analysis?
- Yes
- Did the statistical methods examine changes in outcome measures from before to after the intervention? Were statistical tests done that provided p values for the pre-to-post changes?
- Yes
- Were outcome measures of interest taken multiple times before the intervention and multiple times after the intervention (i.e., did they use an interrupted time-series design)?
- Yes
- If the intervention was conducted at a group level (e.g., a whole hospital, a community, etc.) did the statistical analysis take into account the use of individual-level data to determine effects at the group level?
- No
Key Finding #1
Patients receiving manual therapy instead of surgery had better self-reported function, symptom severity, and pinch grip strength than patients receiving surgery after 1 month.
Key Finding #2
Similar outcomes were achieved in self-reported function, symptom severity, and pinch grip strength at 6 and 12 months in the manual therapy and surgery groups.
Key Finding #3
There were no changes in cervical range of motion of either group, despite the manual therapy group receiving targeted interventions to the cervical spine for musculoskeletal restrictions.
Please provide your summary of the paper
This paper is a randomized control trial that assessed the difference in cervical mobility, self reported outcomes, symptoms severity, and pinch grip strength in women experiencing carpal tunnel syndrome (CTS). The women were assigned to either a manual therapy group or surgical group. The assessor, whom were blind to which group the participant was in, reassessed the patients at 1, 3, 6, and 12 months. Patient were assessed using the Boston Carpal Tunnel Questionnaire for self reported outcomes and symptom severity, pinch-tip grip force, and active cervical range of motion. Participants were included in the study if they met the following criteria: pain and paresthesia in the median nerve distribution, positive Tinel sign, and positive Phalen sign. Symptoms had to have persisted for at least 12 months. Further, the electrodiagnostic examination had to reveal deficits of sensory and motor median nerve conduction (ie, median nerve sensory conduction velocity less than 40 m/s and median nerve distal motor latency greater than 4.20 milliseconds). Patients were excluded if they met any of the following criteria: (1) any sensory and/or motor deficit in either the ulnar or radial nerve; (2) age greater than 65 years; (3) previous surgery or steroid injections; (4) multiple diagnoses on the upper extremity (eg, coexisting cervical radiculopathy); (5) cervical, shoulder, or hand trauma; (6) systemic disease causing CTS (eg, diabetes mellitus, thyroid disease); (7) comorbid musculoskeletal medical conditions (eg, rheumatoid arthritis or fibromyalgia); (8) pregnancy; or (9) male sex. The study lost 6 participants by 12 months, but was able to conclude that participants receiving manual therapy had better self reported outcomes, pinch grip strength and symptom severity than those that received surgery. However, at 6 and 12 months, there were no statistical differences in these categories between the groups. Additionally, no changes were seen in cervical range of motion despite the manual group receiving target therapy for cervical musculoskeletal deficits.
Please provide your clinical interpretation of this paper. Include how this study may impact clinical practice and how the results can be implemented.
This paper will be beneficial to clinicians in not only explaining to patients that manual therapy is as effective as surgery long term, but it can help clinicians advocate for the profession. One aspect that was addressed in the article is that manual therapy allows the patient to continue to work and engage in activities, while surgery impedes function in the short-term. When seeing patients with CTS, it may be beneficial to explain to them that more patients have seen better short term results from manual therapy and equal long term results to surgery. This paper can also be used to help clinicians advocate for the profession. With research showing the manual therapy is just as effective as surgery, this can help PTs advocate that a more conservative and cost-effective option is available for equal results. A few aspects that may need to be considered is that this study was only conducted with women and chronic pain. This does not consider men with CTS or subacute pain that patients may be experiencing. Additionally, cervical manual therapy was shown to be ineffective for CTS. When considering patients with CTS, cervical manual therapy may not be beneficial to spend time on unless symptoms persist to the shoulder or neck. If pain does persist that far from the carpal tunnel, it may be of benefit to assess for cervical radiculopathy or a brachial plexus injury and/or compression.
