Carpal Tunnel SyndromeNCT06550284
Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing
A study testing Physical Therapy in people with Carpal Tunnel Syndrome, run by Brooke Army Medical Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Carpal Tunnel Syndrome
- What is being tested?
- Physical Therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Nov 2024to Jul 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Brooke Army Medical Center
San Antonio, Texas, 78234
Cortney Shewmaker, DPT, 417-766-7414, cortney.c.shewmaker.mil@health.mil
About this study
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.
Read the 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.
- Conditions
- Carpal Tunnel Syndrome
- Being tested
- Physical Therapy
- Keywords
- carpal tunnel syndrome, quantitative sensory testing, median nerve, neuropathy, small nerve fiber
- Medical subject headings
- Carpal Tunnel Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Physical TherapyOther
The intervention will be physical therapy standard care.
| Study group | Role | What they receive |
|---|---|---|
| Carpal Tunnel Syndrome | Experimental | Age 18-65 years with unilateral carpal tunnel syndrome. Receives: Other: Physical Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment until the end of the study at 12 weeks
Secondary outcomes (2)
Boston Carpal Tunnel Questionnaire (BCTQ)
The 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.
Measured: From enrollment until the end of the study at 12 weeks
Numeric Pain Rating Scale (NPRS)
he 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.
Measured: From enrollment until the end of the study at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2024
- Study start12 Nov 2024
- Primary completionJul 2025 (estimated)
- Study completionJul 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Carpal Tunnel SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Brooke Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Principal investigator, Cortney Shewmaker, Brooke Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06550284
- Sponsor's protocol ID
- C.2024.041
- Status last verified
- Feb 2025
- First submitted
- 9 Aug 2024
- Last updated
- 5 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Requests for deidentified data will be considered on a case by case basis.
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Small Nerve Fiber Activity in Patients with Carpal Tunnel Syndrome Assessed Via Quantitative Sensory Testing
- ClinicalTrials.gov ID
- NCT06550284
- Acronym / sponsor ID
- C.2024.041
- Conditions
- Carpal Tunnel Syndrome
- Keywords
- carpal tunnel syndrome, quantitative sensory testing, median nerve, neuropathy, small nerve fiber
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Brooke Army Medical CenterUS federal agency
- Study start
- 12 Nov 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Jul 2025 (estimated)
- First posted
- 13 Aug 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Carpal Tunnel Syndrome | Experimental | Other: Physical TherapyAge 18-65 years with unilateral carpal tunnel syndrome. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Physical TherapyThe intervention will be physical therapy standard care. | Other | Carpal Tunnel Syndrome |
Primary outcome
Quantitative Sensory Testing (QST)
Time frame: From enrollment until the end of the study at 12 weeks
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.
2 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Feb 2025.
- Individual participant dataSharing planned: Undecided. Requests for deidentified data will be considered on a case by case basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Physical Therapy in people with Carpal Tunnel Syndrome, run by Brooke Army Medical Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cortney C Shewmaker, DPT (417-766-7414, cortney.c.shewmaker.mil@health.mil), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Quantitative Sensory Testing (QST) (time frame: From enrollment until the end of the study at 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Feb 2025.