Effects of Radial Pressure Wave Therapy Modulation in Patients With Carpal Tunnel Syndrome: A Double-Blind Randomized Clinical Trial.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 44
- Locations
- 1
- Primary Endpoint
- Change in Pain Intensity Measured with the Numeric Pain Rating Scale.
Study Overview
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.
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. Forty-four 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Outcomes Assessor)
Masking Description
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.
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
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.
Intervention: Modulated-Dose Radial Pressure Wave Therapy. (Device)
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.
Intervention: Fixed-Dose Radial Pressure Wave Therapy. (Device)
Outcomes
Primary Outcomes
Change in Pain Intensity Measured with the Numeric Pain Rating Scale.
Time Frame: Baseline, 2 months, 4 months, and 6 months after treatment initiation.
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.
Secondary Outcomes
- Change in Self-Reported Function Using the Boston Carpal Tunnel Questionnaire.(Baseline, 2 months, 4 months, and 6 months after treatment initiation.)
- Grip strength measured with hydraulic hand dynamometer.(Baseline 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.)
- Change in Sensory Nerve Latency of the Median Nerve.(Baseline and 4 months after the first treatment session.)
- Change in Sensory Nerve Action Potential (SNAP) Amplitude of the Median Nerve.(Baseline and 4 months after the first treatment session.)
Investigators
Armando Tonatiuh Avila Garcia
Chief Department of Physical Medicine and Rehabilitation
Hospital Civil de Guadalajara