NCT00435149

Brief Summary

This study will investigate the effect of one week of immobilization following carpal tunnel release surgery versus no immobilization.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Dec 2006

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, 2006

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

February 12, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 14, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2011

Completed
Last Updated

February 18, 2011

Status Verified

February 1, 2011

Enrollment Period

4.2 years

First QC Date

February 12, 2007

Last Update Submit

February 17, 2011

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

  • Function assessment questionnaire score, pain score questionnaire, and measurements will be used to determine outcome.

    6 months

Study Arms (2)

1

ACTIVE COMPARATOR
Procedure: Carpal tunnel release surgery

2

ACTIVE COMPARATOR
Procedure: Carpal tunnel release surgery

Interventions

Carpal tunnel release surgeryPROCEDURE

Patient will have carpal tunnel release surgery and will be put in a splint after surgery.

1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients undergoing open carpal tunnel release will be included in this study.
  • Patients must have clinical evidence of carpal tunnel syndrome.
  • Patients must have positive EMG results.
  • English speaking patients only.
  • Patient selection factors include:
  • Ability and willingness to follow instructions.
  • Patients who are able and willing to return for follow-up evaluations.
  • Patients of all races and genders.
  • Patients who are able to follow care instructions.

You may not qualify if:

  • Patients less than 18 years old.
  • Patients who are pregnant.
  • Patients unwilling or unable to comply with a rehabilitation program for carpal tunnel release who indicate difficulty or inability to return for follow-up visits prescribed by the study protocol.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Orthopaedic Institute

Nashville, Tennessee, 37232-8828, United States

Location

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Condition Hierarchy (Ancestors)

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

Study Officials

  • Julie Daniels, BBA

    VUMC

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 12, 2007

First Posted

February 14, 2007

Study Start

December 1, 2006

Primary Completion

February 1, 2011

Study Completion

February 1, 2011

Last Updated

February 18, 2011

Record last verified: 2011-02

Locations

US(1)