NCT07070661

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Armando Tonatiuh Avila Garcia · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a double-blind randomized controlled trial designed to explore the effects of different dosing strategies of radial pressure wave therapy in patients with mild to moderate carpal tunnel syndrome. Sixty patients aged 18 to 75 years, with clinical and electrodiagnostic confirmation of CTS, will be recruited and randomly assigned (1:1) to one of two intervention groups: (1) RPWT with constant parameters; or (2) RPWT with modulated parameters (progressive variation of frequency and pressure during each session). All participants will receive three weekly sessions of RPWT and follow a standardized home-based exercise protocol for wrist and hand mobility. The primary outcome will be the change in pain intensity, measured with the Visual Analog Scale VAS. Secondary outcomes include functional status assessed with the Boston Carpal Tunnel Questionnaire, grip strength using a calibrated hydraulic hand dynamometer, and neurophysiological parameters such as sensory conduction velocity, distal motor latency, and CMAP amplitude of the median nerve. Neurophysiological evaluations will be performed using the Nicolet Viking Quest system following standardized protocols. Assessments will take place at baseline, 2 months, and 4 months after treatment initiation, except for electrodiagnostic studies which will be performed only at baseline and at 4 months. Statistical analysis will include mixed-design repeated measures ANOVA to assess intra- and inter-group effects and time-by-group interactions. The study complies with ethical standards and good clinical practice guidelines.

Conditions

• Carpal Tunnel Syndrome (CTS)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-07-15
• Primary completion: 2026-01-15
• Completion: 2026-01-30
• First posted: 2025-07-17
• Last updated: 2025-08-28

Locations

2 sites across 1 country: Mexico