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Radial Pressure Wave Therapy With or Without Parameter Modulation for Carpal Tunnel Syndrome.

NCT07070661 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-05-04

No results posted yet for this study

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.

Conditions

  • Carpal Tunnel Syndrome (CTS)

Interventions

DEVICE

Fixed-Dose Radial Pressure Wave Therapy.

Radial pressure wave therapy will be delivered using the BTL-6000 device. Parameters such as frequency and pressure will remain constant throughout each session. Each participant will receive one session per week for three weeks. The treatment will follow a standardized protocol previously established in the literature and based on patient tolerance.

DEVICE

Modulated-Dose Radial Pressure Wave Therapy.

The BTL-6000 device will be used to deliver therapy with dynamic modulation of frequency and/or pressure within each session, following a structured protocol aiming to optimize clinical response.

Sponsors & Collaborators

  • University of Guadalajara

    collaborator OTHER

  • Armando Tonatiuh Avila Garcia

    lead OTHER

Principal Investigators

  • Tonatiuh Avila, MD · Hospital Civil de Guadalajara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-07-15
Primary Completion
2026-01-15
Completion
2026-01-30

Countries

  • Mexico

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07070661 on ClinicalTrials.gov