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Early Motion Following Carpal Tunnel Release

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00845325
First Posted: February 18, 2009
Last Update Posted: April 29, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Stephen Colbert, University of Missouri-Columbia
February 16, 2009
February 18, 2009
April 29, 2016
December 2008
April 2016   (Final data collection date for 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 ]
Same as current
Complete list of historical versions of study NCT00845325 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
Early Motion Following Carpal Tunnel Release
Early Motion Following Carpal Tunnel Release, a Randomized Control Trial

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.

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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Carpal Tunnel Syndrome
  • 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
  • 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
  • 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.
    Intervention: Behavioral: Group One
  • 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.
    Intervention: Behavioral: Control Group Two
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
16
April 2016
April 2016   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
Child, Adult, Senior
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT00845325
1108957
No
Not Provided
Plan to Share IPD: No
Stephen Colbert, University of Missouri-Columbia
University of Missouri-Columbia
Not Provided
Principal Investigator: Stephen H Colbert, MD University of Missouri-Columbia
University of Missouri-Columbia
April 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP