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

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

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06550284
Enrollment
48
Registered
2024-08-13
Start date
2024-11-12
Completion date
2025-07-31
Last updated
2025-02-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Carpal Tunnel Syndrome

Keywords

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

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.

Detailed description

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.

Interventions

OTHERPhysical Therapy

The intervention will be physical therapy standard care.

Sponsors

Brooke Army Medical Center
Lead SponsorFED

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Quantitative Sensory Testing (QST)From enrollment until the end of the study at 12 weeksQST 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.

Secondary

MeasureTime frameDescription
Boston Carpal Tunnel Questionnaire (BCTQ)From enrollment until the end of the study at 12 weeksThe BCTQ is a self-based outcome scale measured with 2-parts, the symptom severity scale and functional status scale. Both scales are likert scales 1-5.
Numeric Pain Rating Scale (NPRS)From enrollment until the end of the study at 12 weekshe NPRS is an 11-point scale ('0' indicating no pain, and '10' worst imaginable pain) that will be used to assess pain intensity. This will be measured as the mean of three pain ratings: best pain rating over 24 hours, worst pain rating over 24 hours, and current pain rating.

Countries

United States

Contacts

Primary ContactCortney C Shewmaker, DPT
cortney.c.shewmaker.mil@health.mil417-766-7414

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026