A previous randomised controlled trial reported greater efficacy of surgery than of
splinting for patients with carpal tunnel syndrome. Our aim was to compare surgical
versus multi-modality, non-surgical treatment for patients with carpal tunnel syndrome
without denervation. We hypothesised that surgery would result in improved functional
and symptom outcomes.
In this parallel-group randomised controlled trial, we randomly assigned 116 patients
from eight academic and private practice centres, using computer-generated random
allocation stratified by site, to carpal tunnel surgery (n=57) or to a well-defined,
non-surgical treatment (including hand therapy and ultrasound; n=59). The primary
outcome was hand function measured by the Carpal Tunnel Syndrome Assessment Questionnaire
(CTSAQ) at 12 months assessed by research personnel unaware of group assignment. Analysis
was by intention to treat. This trial is registered with ClinicalTrials.gov, number
NCT00032227.
44 (77%) patients assigned to surgery underwent surgery. At 12 months, 101 (87%) completed
follow-up and were analysed (49 of 57 assigned to surgery and 52 of 59 assigned to
non-surgical treatment). Analyses showed a significant 12-month adjusted advantage
for surgery in function (CTSAQ function score: Delta -0.40, 95% CI 0.11-0.70, p=0.0081)
and symptoms (CTSAQ symptom score: 0.34, 0.02-0.65, p=0.0357). There were no clinically
important adverse events and no surgical complications.
Symptoms in both groups improved, but surgical treatment led to better outcome than
did non-surgical treatment. However, the clinical relevance of this difference was
modest. Overall, our study confirms that surgery is useful for patients with carpal
tunnel syndrome without denervation.
NIH/NIAMS 5P60AR048093 and the Intramural Research Program of the NIH Clinical Center.