Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing

NCT ID: NCT06550284

Last Updated: 2025-02-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-11-12

Study Completion Date

2025-07-31

Brief Summary

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The diagnosis of carpal tunnel syndrome (CTS) is typically based on clinical findings and confirmatory electrodiagnostic testing. However, electrodiagnostic testing can only assess large A-alpha and A-beta nerve fibers. Quantitative sensory testing (QST) is a series of tests used to assess small nerve fiber changes in the A-delta, c-fibers, and A-beta nerve fibers as well. Previous studies have used QST to assess small nerve fiber changes related to carpal tunnel syndrome and found changes compared to controls. This study will utilize a course of standard physical therapy care and assess for any changes to small nerve fiber activity and how those changes may or may not relate to patient outcomes.

Detailed Description

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Purpose: To assess changes in A-beta, A-deta, and C-fiber function after standard physical therapy interventions in individuals with CTS.

Specific Aim 1 (primary aim): Determine if A-beta, A-deta, and C-fiber functions change following a course of Physical Therapy (PT) in individuals with CTS.

Specific Aim 2 (secondary aim): Describe the relationship between changes in QST and changes in a patient-reported outcome measure after a course of PT in individuals with a clinical diagnosis of CTS.

Specific Aim 3 (secondary aim): Determine if there are differences in A-beta, A-deta, and C-fiber function between the affected and unaffected wrists in individuals with a clinical diagnosis of CTS.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Carpal Tunnel Syndrome

Age 18-65 years with unilateral carpal tunnel syndrome.

Group Type EXPERIMENTAL

Physical Therapy

Intervention Type OTHER

The intervention will be physical therapy standard care.

Interventions

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Physical Therapy

The intervention will be physical therapy standard care.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

DEERS eligible Age 18-65 Pain and paresthesia in the median nerve distribution A positive Phalen test A positive Tinel test over the carpal tunnel Willing to attend physical therapy

Exclusion Criteria

Nerve root signs consistent with a radiculopathy Suspected radial and ulnar nerve involvement based on monofilament testing Bilateral CTS Previous hand surgery Injections in the upper quarter in the last 6 months Cervical, shoulder, or UE trauma in the last 6 months Currently pregnant or postpartum within the last 6 months No more than minimal care (evaluation and patient education, 1 visit) for the current episode
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brooke Army Medical Center

FED

Sponsor Role lead

Responsible Party

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Cortney Shewmaker

Orthopedic Manual Physical Therapy Fellow

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Brooke Army Medical Center

San Antonio, Texas, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Cortney C Shewmaker, DPT

Role: CONTACT

417-766-7414

Facility Contacts

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Cortney Shewmaker, DPT

Role: primary

417-766-7414

Other Identifiers

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C.2024.041

Identifier Type: -

Identifier Source: org_study_id

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