NCT00845325

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2008

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

February 16, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 18, 2009

Completed
7.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
Last Updated

April 29, 2016

Status Verified

April 1, 2016

Enrollment Period

7.3 years

First QC Date

February 16, 2009

Last Update Submit

April 27, 2016

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal tunnel releaseRehabilitationEarly motion

Outcome Measures

Primary Outcomes (1)

  • 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.

    1 week, 3 weeks, 3 months, and 1 year postoperatively

Study Arms (2)

Group One

ACTIVE COMPARATOR

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

Behavorial Control Group Two

OTHER

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

Interventions

Group OneBEHAVIORAL

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.

Also known as: early motion/rehabilitation
Group One
Control Group TwoBEHAVIORAL

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.

Also known as: Delayed rehabilitation
Behavorial Control Group Two

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Clinical diagnosis of carpal tunnel syndrome
  • Recommended for carpal tunnel release

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Missouri

Columbia, Missouri, 65212, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

One-Carbon Group TransferasesRehabilitation

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

TransferasesEnzymesEnzymes and CoenzymesAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Stephen H Colbert, MD

    University of Missouri-Columbia

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

February 16, 2009

First Posted

February 18, 2009

Study Start

December 1, 2008

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

April 29, 2016

Record last verified: 2016-04

Data Sharing

IPD Sharing
Will not share

Locations

US(1)