Recruiting

Observational Study

Sponsor:

Brooke Army Medical Center

Code:

NCT06550284

Conditions

Carpal Tunnel Syndrome

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Physical Therapy

Study Details

Brief summary:

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.

Conditions

Carpal Tunnel Syndrome

Study ID

NCT06550284

Start date

Nov 12, 2024

Status verified date

Feb, 2025

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Carpal Tunnel Syndrome

Age 18-65 years with unilateral carpal tunnel syndrome.

Interventions

Physical Therapy

The intervention will be physical therapy standard care.

Primary outcome measure

  • Quantitative Sensory Testing (QST) [ Time Frame: From enrollment until the end of the study at 12 weeks ]

Central Contacts and Locations

Central contacts

Cortney C Shewmaker, DPT

417-766-7414cortney.c.shewmaker.mil@health.mil

Locations

Brooke Army Medical Center

Recruiting

San Antonio, Texas, United States, 78234

Contacts

Cortney Shewmaker, DPT

417-766-7414cortney.c.shewmaker.mil@health.mil

More Information

Sponsor

Brooke Army Medical Center

Last update posted

Feb 5, 2025

Last verified

Feb, 2025

Keywords

  • carpal tunnel syndrome
  • quantitative sensory testing
  • median nerve
  • neuropathy
  • small nerve fiber

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Brooke Army Medical Center on 2025-02-05.