Early Motion Following Carpal Tunnel Release

This study is currently recruiting participants. (see Contacts and Locations)
Verified February 2014 by University of Missouri-Columbia
Sponsor:
Information provided by (Responsible Party):
Stephen Colbert, University of Missouri-Columbia
ClinicalTrials.gov Identifier:
NCT00845325
First received: February 16, 2009
Last updated: February 8, 2014
Last verified: February 2014
  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.


Condition Intervention
Carpal Tunnel Syndrome
Behavioral: Group One
Behavioral: Control Group Two

Study Type: Interventional
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

Resource links provided by NLM:


Further study details as provided by University of Missouri-Columbia:

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. [ Time Frame: 1 week, 3 weeks, 3 months, and 1 year postoperatively ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: December 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00845325

Contacts
Contact: Chase D Derrick, MD 573-882-2275 derrickcd@health.missouri.edu
Contact: Stephen H Colbert, MD 573-882-2275 colberts@health.missouri.edu

Locations
United States, Missouri
University of Missouri Recruiting
Columbia, Missouri, United States, 65212
Contact    573-882-3181    irb@missouri.edu   
Principal Investigator: Stephen H Colbert, MD         
Sub-Investigator: Chase D Derrick, MD         
Sub-Investigator: Thomas W McEwan, MD         
Sponsors and Collaborators
University of Missouri-Columbia
Investigators
Principal Investigator: Stephen H Colbert, MD University of Missouri-Columbia
  More Information

No publications provided

Responsible Party: Stephen Colbert, Assistant Professor, University of Missouri-Columbia
ClinicalTrials.gov Identifier: NCT00845325     History of Changes
Other Study ID Numbers: 1108957
Study First Received: February 16, 2009
Last Updated: February 8, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of Missouri-Columbia:
Carpal tunnel release
Rehabilitation
Early motion

Additional relevant MeSH terms:
Carpal Tunnel Syndrome
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Nerve Compression Syndromes
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries

ClinicalTrials.gov processed this record on July 22, 2014