Carpal Tunnel Syndrome Clinical Trial
Official title:
Comparison Results of Carpal Tunnel Release Between Standard Incision and Limited Incision Using PSU Retractor: A Randomized Controlled Trial
Verified date | May 2012 |
Source | Prince of Songkla University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Thailand: Ethical Committee |
Study type | Interventional |
The investigators study aims to evaluate both efficacy and safety of carpal tunnel release
using limited incision with the PSU retractor compared to standard incision.
The investigators will do a randomized controlled trial in 60 patients with carpal tunnel
release and evaluate for outcome regarding pain, VAS score, return to work time, CTS score
and complications at 6 months.
Status | Enrolling by invitation |
Enrollment | 60 |
Est. completion date | December 2012 |
Est. primary completion date | September 2012 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 15 Years to 80 Years |
Eligibility |
Inclusion Criteria: - Patients diagnosed as carpal tunnel syndrome who failed to conservative treatment 3 months Exclusion Criteria: - Underlying disease such as : DM, neuropathy - Previous wrist or hand surgery in the same side - Previous wrist and hand trauma - Pregnancy |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Thailand | Prince of Songkla University | Hatyai | Songkhla |
Lead Sponsor | Collaborator |
---|---|
Prince of Songkla University |
Thailand,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CTS score | 1 year | No | |
Secondary | VAS score | 1 year | No | |
Secondary | return to work time | 1 year | No | |
Secondary | satisfaction score | 1 year | No | |
Secondary | complication rate | 1 year | No |
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