Radial Pressure Wave Therapy With or Without Parameter Modulation for Carpal Tunnel Syndrome. (NCT07070661) | Clinical Trial Compass
CompletedNot Applicable
Radial Pressure Wave Therapy With or Without Parameter Modulation for Carpal Tunnel Syndrome.
Mexico60 participantsStarted 2025-07-15
Plain-language summary
This study aims to evaluate the clinical effects of radial pressure wave therapy in patients with a confirmed diagnosis of mild to moderate carpal tunnel syndrome. Participants will be randomly assigned to receive radial pressure wave therapy using either a modulated or a constant parameter dosing protocol. The intervention consists of three weekly sessions, and outcomes will be assessed at baseline, 2 months, and 4 months after the first session. The primary outcome is pain intensity measured by the Visual Analog Scale, while secondary outcomes include functional status evaluated with the Boston Carpal Tunnel Questionnaire, grip strength, and electrodiagnostic parameters of the median nerve. The study is conducted in the Physical Medicine and Rehabilitation Service of the Antiguo Hospital Civil de Guadalajara "Fray Antonio Alcalde," and has been approved by the hospital's Ethics Committee.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults aged 18 to 75 years.
* Clinical diagnosis of carpal tunnel syndrome based on symptoms such as nocturnal paresthesia, numbness in the median nerve distribution, and/or thenar weakness.
* At least one positive provocative test (e.g., Tinel's, Phalen's, or Durkan's test).
* Symptoms present for at least 1 month.
* NPRS (Numeric Pain Rating Scale) score ≥ 4 at baseline.
* Able and willing to attend all intervention sessions and follow-up assessments.
* Able to provide informed consent.
Exclusion Criteria:
* Prior wrist surgery on the affected side.
* Prior treatment with radial pressure wave therapy for CTS.
* Diagnosis of polyneuropathy, cervical radiculopathy, or systemic conditions affecting nerve function (e.g., uncontrolled diabetes, hypothyroidism, rheumatoid arthritis).
* Severe thenar atrophy or muscle wasting.
* Pacemaker or other implanted electronic devices.
* Pregnancy.
* Currently participating in another clinical trial or intervention study.
* Inability to understand or complete the study procedures.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Measured with the Numeric Pain Rating Scale.
Timeframe: Baseline, 2 months, and 4 months after treatment initiation.