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

NCT07070661 | Completed

• 1 other identifier: CEI 144/25
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Carpal Tunnel Syndrome; Radial Pressure Wave Therapy; Extracorporeal Shock Wave Therapy; Median Nerve; Neuropathic Pain; Hand Function; Non-invasive Treatment; Physical Medicine and Rehabilitation; Electrophysiology; Grip Strength

Outcome Measures

Primary Outcomes (1)

• Change in Pain Intensity Measured with the Numeric Pain Rating Scale.

  Pain intensity will be assessed using the 11-point Numeric Pain Rating Scale (0 = no pain, 10 = worst imaginable pain). The primary endpoint is the change in Numeric Pain Rating Scale score from baseline to the follow-up visits.

  Baseline, 2 months, and 4 months after treatment initiation.

Secondary Outcomes (7)

• Change in Self-Reported Function Using the Boston Carpal Tunnel Questionnaire.

  Baseline, 2 months, and 4 months after treatment initiation.

• Grip strength measured with hydraulic hand dynamometer.

  Baseline, 2 months, and 4 months after the first treatment session.

• Change in Distal Motor Latency of the Median Nerve.

  Baseline and 4 months after the first treatment session.

• Change in Compound Muscle Action Potential (CMAP) Amplitude of the Median Nerve.

  Baseline and 4 months after the first treatment session.

• Change in Motor Nerve Conduction Velocity of the Median Nerve.

  Baseline and 4 months after the first treatment session.

Study Arms (2)

Fixed-Dose Radial Pressure Wave Therapy.

EXPERIMENTAL

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.

Device: Fixed-Dose Radial Pressure Wave Therapy.

Modulated-Dose Radial Pressure Wave Therapy.

EXPERIMENTAL

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.

Device: Modulated-Dose Radial Pressure Wave Therapy.

Interventions

Fixed-Dose Radial Pressure Wave Therapy. DEVICE

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.

Fixed-Dose Radial Pressure Wave Therapy.

Modulated-Dose Radial Pressure Wave Therapy. DEVICE

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.

Modulated-Dose Radial Pressure Wave Therapy.

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Armando Tonatiuh Avila Garcia: lead
• University of Guadalajara: collaborator

Study Sites (1)

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

Location

Related Publications (24)

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MeSH Terms

Conditions

Carpal Tunnel Syndrome; Neuralgia

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tonatiuh Avila, MD

  Hospital Civil de Guadalajara

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Participants and outcome assessors (including the specialists in rehabilitation and neurophysiology) are blinded to group allocation. The intervention is applied by a therapist aware of the group assignment, but not involved in the evaluation or data analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief Department of Physical Medicine and Rehabilitation

Model Details: Double-blind randomized controlled trial with two parallel groups comparing constant-dose versus modulated-dose radial pressure wave therapy in patients with carpal tunnel syndrome.

Study Record Dates

• First Submitted: June 27, 2025
• First Posted: July 17, 2025
• Study Start: July 15, 2025
• Primary Completion: January 15, 2026
• Study Completion: January 30, 2026
• Last Updated: May 4, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: From February 2026 to February 2027.
• Access Criteria: 1. Qualified researchers who have received IRB approval. 2. Prior reasonable request by email. 3. Data will be made available by PDF files or other non-editable formats.

Locations

ME (1)