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

NCT06550284 | Recruiting

• 1 other identifier: C.2024.041
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Quantitative Sensory Testing (QST)

  QST is a test method that measures sensory thresholds for temperature sensations, touch, vibration, and pain and is described in section 10.1. All thermal testing (CDT, WDT, CPT, and HPT) will be performed via the TSA 2 Thermosensory Stimulator.

  From enrollment until the end of the study at 12 weeks

Secondary Outcomes (2)

• Boston Carpal Tunnel Questionnaire (BCTQ)

  From enrollment until the end of the study at 12 weeks

• Numeric Pain Rating Scale (NPRS)

  From enrollment until the end of the study at 12 weeks

Study Arms (1)

Carpal Tunnel Syndrome

EXPERIMENTAL

Age 18-65 years with unilateral carpal tunnel syndrome.

Other: Physical Therapy

Interventions

Physical Therapy OTHER

The intervention will be physical therapy standard care.

Carpal Tunnel Syndrome

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Brooke Army Medical Center: lead

Study Sites (1)

Brooke Army Medical Center

San Antonio, Texas, 78234, United States

RECRUITING

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Physical Therapy Modalities

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

Therapeutics; Rehabilitation

Central Study Contacts

Cortney C Shewmaker, DPT

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Orthopedic Manual Physical Therapy Fellow

Study Record Dates

• First Submitted: August 9, 2024
• First Posted: August 13, 2024
• Study Start: November 12, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 5, 2025

Record last verified: 2025-02

Locations

US (1)