Early Motion Following Carpal Tunnel Release

Carpal Tunnel Syndrome Clinical Trial

Official title:

Early Motion Following Carpal Tunnel Release, a Randomized Control Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00845325
• Other study ID #: 1108957
• Status: Completed
• Phase: N/A
• First received: February 16, 2009
• Last updated: April 27, 2016
• Start date: December 2008
• Est. completion date: April 2016

Study information

• Verified date: April 2016
• Source: University of Missouri-Columbia
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

To objectively and subjectively assess two modes of commonly employed rehabilitation and confirm a superior method to treat patients following carpal tunnel release.

One of the problems following carpal tunnel release (CTR) for carpal tunnel syndrome, and all hand surgeries, is the debilitation in the postoperative period. This relates to muscle atrophy and joint stiffness due to immobilization or relative inactivity in the postoperative period. Specifically, patients suffer increased days off from work, lost wages, and difficulties with activities of daily living affecting the patient and society at large. CTR is a very common procedure in hand surgery making it easy to study and important to optimize the postoperative care.

Description:

The surgical procedure, carpal tunnel release, will be performed in a standard open fashion. In a random fashion, the patients will be placed into either of two rehabilitation groups following CTR with specifically different postoperative instructions after the procedure.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Clinical diagnosis of carpal tunnel syndrome

• Recommended for carpal tunnel release

Exclusion Criteria:

• Severe thenar weakness

• proximal neuropathy of the same arm.

• generalized peripheral neuropathy

• active psychiatric disorder

• chronic renal failure require dialysis

• reflex sympathetic dystrophy

• previous injury of affected wrist or median nerve

• simultaneous ipsilateral upper extremity surgery

• carpal tunnel syndrome with acute injury

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Behavioral:
• Group One
They will begin exercises on the day after surgery and perform them three times daily for two weeks. The patients will have no restrictions concerning activity or return to work.
• Control Group Two
The patients will be restricted from using that hand during its implementation. One week following surgery the splint will be removed and the patient will be instructed to begin activity without restriction.

Locations

Country	Name	City	State
United States	University of Missouri	Columbia	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
University of Missouri-Columbia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	days to return to activities of daily living, return to work, grip strength, pinch strength, digital sensibility, subjective pain control, number of pain pills used, grading of success,and any complications encountered.		1 week, 3 weeks, 3 months, and 1 year postoperatively	No