Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Physical Therapy.
- Who it may be relevant to
- Registry conditions: Carpal Tunnel Syndrome. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
- Other Physical Therapy
The intervention will be physical therapy standard care.
Primary outcome measures
- Quantitative Sensory Testing (QST) [Time frame: From enrollment until the end of the study at 12 weeks]
Secondary outcome measures (2)
- Boston Carpal Tunnel Questionnaire (BCTQ) [Time frame: From enrollment until the end of the study at 12 weeks]
- Numeric Pain Rating Scale (NPRS) [Time frame: From enrollment until the end of the study at 12 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 1 center
- Brooke Army Medical Center — San Antonio
Identifiers
NCT: NCT06550284 · C.2024.041