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NCT Number: NCT07070661

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

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.

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Key information

Conditions

Carpal Tunnel Syndrome (CTS) Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Signs and Symptoms Sprains and Strains Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Civil de Guadalajara Fray Antonio Alcalde

Guadalajara, Jalisco, 44280, Mexico

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

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

    Time frame: Baseline, 2 months, and 4 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

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

    Time frame: Baseline, 2 months, and 4 months after treatment initiation.

    Function will be evaluated with the Functional Status Scale of the Boston Carpal Tunnel Questionnaire, which includes 8 items rated from 1 (no difficulty) to 5 (cannot perform activity). The mean score will be analyzed.

  2. Grip strength measured with hydraulic hand dynamometer.

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

    Grip strength will be assessed using a calibrated Baseline® hydraulic hand dynamometer (range: 0-100 kg), following the standardized protocol recommended by the American Society of Hand Therapists. Patients will be seated with the shoulder adducted and neutrally rotated, elbow flexed at 90°, forearm in neutral position, and wrist in slight extension. Each participant will perform three maximal grip attempts, with brief rest periods in between, and the highest value will be recorded for analysis.

  3. Change in Distal Motor Latency of the Median Nerve.

    Time frame: Baseline and 4 months after the first treatment session.

    Distal motor latency of the median nerve will be assessed using standard nerve conduction study protocols with surface electrodes and supramaximal stimulation. Values will be recorded in milliseconds, and the change from baseline to follow-up will be analyzed.

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

    Time frame: Baseline and 4 months after the first treatment session.

    CMAP amplitude will be measured from the median nerve using a standard supramaximal stimulation protocol and recorded in millivolts. The change in peak amplitude between baseline and follow-up will be used for analysis.

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

    Time frame: Baseline and 4 months after the first treatment session.

    Median motor nerve conduction velocity will be assessed using standard nerve conduction studies and calculated in meters per second. The highest conduction velocity from each assessment will be considered for analysis.

  6. Change in Sensory Nerve Latency of the Median Nerve.

    Time frame: Baseline and 4 months after the first treatment session.

    Latency of the sensory action potential in the median nerve will be measured using standard antidromic stimulation techniques and recorded in milliseconds. The change from baseline to follow-up will be analyzed.

  7. Change in Sensory Nerve Action Potential (SNAP) Amplitude of the Median Nerve.

    Time frame: Baseline and 4 months after the first treatment session.

    SNAP amplitude of the median nerve will be recorded using standard protocols and expressed in microvolts. The highest amplitude obtained will be compared between baseline and follow-up.

Sponsors and collaborators

Lead sponsor

Armando Tonatiuh Avila Garcia

Other

Collaborators

  • University of Guadalajara

Registry information

Official study title

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

Acronym: RPWT in CTS

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jul 17, 2025
Registry last updated
May 4, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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