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Early Motion Following Carpal Tunnel Release

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Group One
Control Group Two
Sponsored by
University of Missouri-Columbia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Carpal Tunnel Syndrome focused on measuring Carpal tunnel release, Rehabilitation, Early motion

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Missouri

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Other

Arm Label

Group One

Behavorial Control Group Two

Arm 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 restrictions concerning activity or return to work.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

First Posted
February 16, 2009
Last Updated
April 27, 2016
Sponsor
University of Missouri-Columbia
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1. Study Identification

Unique Protocol Identification Number
NCT00845325
Brief Title
Early Motion Following Carpal Tunnel Release
Official Title
Early Motion Following Carpal Tunnel Release, a Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Missouri-Columbia

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
Carpal tunnel release, Rehabilitation, Early motion

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group One
Arm Type
Active Comparator
Arm 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 restrictions concerning activity or return to work.
Arm Title
Behavorial Control Group Two
Arm Type
Other
Arm 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.
Intervention Type
Behavioral
Intervention Name(s)
Group One
Other Intervention Name(s)
early motion/rehabilitation
Intervention 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.
Intervention Type
Behavioral
Intervention Name(s)
Control Group Two
Other Intervention Name(s)
Delayed rehabilitation
Intervention 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.
Primary Outcome Measure Information:
Title
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

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen H Colbert, MD
Organizational Affiliation
University of Missouri-Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Missouri
City
Columbia
State/Province
Missouri
ZIP/Postal Code
65212
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Early Motion Following Carpal Tunnel Release

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