Effects of Radial Pressure Wave Therapy Modulation in Patients With Carpal Tunnel Syndrome: A Double-Blind Randomized Clinical Trial.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 75
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
NOT_YET_RECRUITING
Guadalajara
Hospital Civil de Guadalajara Fray Antonio Alcalde
RECRUITING
Guadalajara
Contact Information
Primary
Tonatiuh Avila, MD
atavila@hcg.gob.mx
523339424400
Backup
Ana Villagrana, MD
alvillagrana@hcg.gob.mx
523339424400
Time Frame
Start Date: 2025-07-15
Estimated Completion Date: 2026-01-30
Participants
Target number of participants: 60
Treatments
Experimental: Fixed-Dose Radial Pressure Wave Therapy.
Participants assigned to this group will receive radial pressure wave therapy using a standardized protocol with fixed parameters of frequency and pressure throughout each session. The treatment will be administered once a week for three consecutive weeks. This group serves as the reference condition for comparative purposes.
Experimental: Modulated-Dose Radial Pressure Wave Therapy.
Participants in this group will receive radial pressure wave therapy with dynamic modulation of frequency and pressure during each session. The modulation will follow a predefined progressive scheme aimed at optimizing tissue response. Treatment will be delivered once a week for three consecutive weeks.
Sponsors
Leads: Armando Tonatiuh Avila Garcia
Collaborators: University of Guadalajara

This content was sourced from clinicaltrials.gov