Early Motion Following Carpal Tunnel Release

NCT ID: NCT00845325

Last Updated: 2016-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2016-04-30

Brief Summary

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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

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Group One

Intervention Type BEHAVIORAL

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.

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.

Group Type OTHER

Control Group Two

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type 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.

Intervention Type BEHAVIORAL

Other Intervention Names

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early motion/rehabilitation Delayed rehabilitation

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Missouri-Columbia

OTHER

Sponsor Role lead

Responsible Party

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Stephen Colbert

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Stephen H Colbert, MD

Role: PRINCIPAL_INVESTIGATOR

University of Missouri-Columbia

Locations

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University of Missouri

Columbia, Missouri, United States

Site Status

Countries

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United States

Other Identifiers

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1108957

Identifier Type: -

Identifier Source: org_study_id

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