NCT00336622

Brief Summary

The purpose of this randomized clinical trial was to examine the efficacy of a splinting (fabricated versus off-the-shelf splint)and exercise (nerve and tendon gliding versus no exercise) interventions to alter the clinical course of Carpal Tunnel Syndrome (CTS). We hypothesized that the fabricated splint with nerve and tendon gliding exercises condition would yield the best functional outcomes at 4 and 8 weeks posttesting.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
56

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2004

Shorter than P25 for not_applicable

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

June 1, 2004

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2005

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2005

Completed
1.3 years until next milestone

First Submitted

Initial submission to the registry

June 12, 2006

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 14, 2006

Completed
Last Updated

February 21, 2011

Status Verified

February 1, 2011

Enrollment Period

9 months

First QC Date

June 12, 2006

Last Update Submit

February 18, 2011

Conditions

Carpal Tunnel Syndrome

Keywords

Carpal Tunnel SyndromeSplints

Outcome Measures

Primary Outcomes (1)

  • Carpal Tunnel Syndrome Symptom Severity & Functional Status Scale

    Self-report tool

    Pre-Post

Study Arms (2)

Experimental

EXPERIMENTAL

Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises

Device: Splint fabricated by an OT versus an off-the-shelf splint

Control

ACTIVE COMPARATOR

Off-the-shelf splint

Device: Splint fabricated by an OT versus an off-the-shelf splint

Interventions

Splint fabricated by an OT versus an off-the-shelf splintDEVICE

Experimental: Custom-made splint and tendon-nerve gliding exercises Custom-made splint and no tendon-nerve gliding exercises Control: Control: Off-the-shelf splint and tendon-nerve gliding exercises Off-the-shelf splint and no tendon-nerve gliding exercises

Also known as: Experimental, Control
ControlExperimental

Eligibility Criteria

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

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

  • Teresa L. Brininger, PhD

    U.S. Army, University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

June 12, 2006

First Posted

June 14, 2006

Study Start

June 1, 2004

Primary Completion

March 1, 2005

Study Completion

March 1, 2005

Last Updated

February 21, 2011

Record last verified: 2011-02