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| Name | Class |
|---|---|
| University of Guadalajara | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Self-Reported Function Using the Boston Carpal Tunnel Questionnaire. | 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. | Baseline, 2 months, and 4 months after treatment initiation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tonatiuh Avila, MD | Hospital Civil de Guadalajara | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Civil de Guadalajara Fray Antonio Alcalde | Guadalajara | Jalisco | 44280 | Mexico |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26683079 | Background | Oteo-Alvaro A, Marin MT, Matas JA, Vaquero J. [Spanish validation of the Boston Carpal Tunnel Questionnaire]. Med Clin (Barc). 2016 Mar 18;146(6):247-53. doi: 10.1016/j.medcli.2015.10.013. Epub 2015 Dec 10. Spanish. | |
| 30211382 | Background | Delgado DA, Lambert BS, Boutris N, McCulloch PC, Robbins AB, Moreno MR, Harris JD. Validation of Digital Visual Analog Scale Pain Scoring With a Traditional Paper-based Visual Analog Scale in Adults. J Am Acad Orthop Surg Glob Res Rev. 2018 Mar 23;2(3):e088. doi: 10.5435/JAAOSGlobal-D-17-00088. eCollection 2018 Mar. |
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The data supporting the findings of this study are available from the lead author upon reasonable request by email.
From February 2026 to February 2027.
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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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.
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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.
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| 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. |
|
| Grip strength measured with hydraulic hand dynamometer. | 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. | Baseline, 2 months, and 4 months after the first treatment session. |
| Change in Distal Motor Latency of the Median Nerve. | 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. | Baseline and 4 months after the first treatment session. |
| Change in Compound Muscle Action Potential (CMAP) Amplitude of the Median Nerve. | 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. | Baseline and 4 months after the first treatment session. |
| Change in Motor Nerve Conduction Velocity of the Median Nerve. | 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. | Baseline and 4 months after the first treatment session. |
| Change in Sensory Nerve Latency of the Median Nerve. | 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. | Baseline and 4 months after the first treatment session. |
| Change in Sensory Nerve Action Potential (SNAP) Amplitude of the Median Nerve. | 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. | Baseline and 4 months after the first treatment session. |
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| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |