Columbia, Missouri 65212

  • Carpal Tunnel Syndrome

Purpose:

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 summary:

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.


Criteria:

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 is Available At:


Original ID:

1108957


NCT ID:

NCT00845325


Secondary ID:


Study Acronym:


Brief Title:

Early Motion Following Carpal Tunnel Release


Official Title:

Early Motion Following Carpal Tunnel Release, a Randomized Control Trial


Overall Status:

Recruiting


Study Phase:

N/A


Genders:

Both


Minimum Age:

N/A


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

University of Missouri-Columbia


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:

Allocation: Randomized, Endpoint Classification: E


Number of Arms:

2


Number of Groups:

0


Total Enrollment:

100


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:Stephen H Colbert, MD
Principal Investigator
University of Missouri-Columbia
Primary Contact:Chase D Derrick, MD
573-882-2275
derrickcd@health.missouri.edu
Backup Contact:Stephen H Colbert, MD
573-882-2275
colberts@health.missouri.edu

Study Dates

Start Date:December 2008
Completion Date:January 2017
Completion Type:Anticipated
Primary Completion Date:January 2017
Primary Completion Type:Anticipated
Verification Date:February 2016
Last Changed Date:February 25, 2016
First Received Date:February 16, 2009

Study Outcomes

Outcome Type:Primary Outcome
Measure: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
Safety Issues:False

Study Interventions

Intervention Type:Behavioral
Name:Control Group Two
Description: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.
Arm Name:Behavorial Control Group Two
Other Name:Delayed rehabilitation
Intervention Type:Behavioral
Name:Group One
Description: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.
Arm Name:Group One
Other Name:early motion/rehabilitation

Study Arms

Study Arm Type:Other
Arm Name:Behavorial Control Group Two
Description: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.
Study Arm Type:Active Comparator
Arm Name:Group One
Description: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 restric

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:University of Missouri-Columbia

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: September 24, 2021

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