Early Motion Following Carpal Tunnel Release
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Early Motion Following Carpal Tunnel Release, a Randomized Control Trial|
- 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. [ Time Frame: 1 week, 3 weeks, 3 months, and 1 year postoperatively ] [ Designated as safety issue: No ]
|Study Start Date:||December 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Group One
The first group (early motion) will have a bulky dressing placed at the time of surgery. They will be instructed to remove the dressing on the first postoperative day and to place a band-aid over the incision. A set of non-weight bearing "stretching" exercises will be explained on the day of surgery and instructions with diagrams sent home with the patient. They will begin these 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.
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.
Other Name: early motion/rehabilitation
Behavorial Control Group Two
The second group will have wrist immobilization splints placed at the time surgery. The thumb and fingers will not have limited motion in this splint. Due to the splint placement, 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.
Behavioral: 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.
Other Name: Delayed rehabilitation
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00845325
|Contact: Chase D Derrick, MDfirstname.lastname@example.org|
|Contact: Stephen H Colbert, MDemail@example.com|
|United States, Missouri|
|University of Missouri||Recruiting|
|Columbia, Missouri, United States, 65212|
|Contact 573-882-3181 firstname.lastname@example.org|
|Principal Investigator: Stephen H Colbert, MD|
|Sub-Investigator: Chase D Derrick, MD|
|Sub-Investigator: Thomas W McEwan, MD|
|Principal Investigator:||Stephen H Colbert, MD||University of Missouri-Columbia|