Radial Pressure Wave Therapy With or Without Parameter Modulation for Carpal Tunnel Syndrome.
NCT ID: NCT07070661
Last Updated: 2025-08-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
60 participants
INTERVENTIONAL
2025-07-15
2026-01-30
Brief Summary
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Detailed Description
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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
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
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.
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.
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.
Interventions
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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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
18 Years
75 Years
ALL
No
Sponsors
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University of Guadalajara
OTHER
Armando Tonatiuh Avila Garcia
OTHER
Responsible Party
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Armando Tonatiuh Avila Garcia
Chief Department of Physical Medicine and Rehabilitation
Principal Investigators
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Tonatiuh Avila, MD
Role: PRINCIPAL_INVESTIGATOR
Hospital Civil de Guadalajara
Locations
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Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Hospital Civil de Guadalajara Fray Antonio Alcalde
Guadalajara, Jalisco, Mexico
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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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Zhang L, Yang T, Pang L, Li Y, Li T, Zhang C, Yao L, Li R, Tang X. Effects of Extracorporeal Shock Wave Therapy in Patients with Mild-to-Moderate Carpal Tunnel Syndrome: An Updated Systematic Review with Meta-Analysis. J Clin Med. 2023 Nov 28;12(23):7363. doi: 10.3390/jcm12237363.
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Schuh CM, Hausner T, Redl HR. A therapeutic shock propels Schwann cells to proliferate in peripheral nerve injury. Brain Circ. 2016 Jul-Sep;2(3):138-140. doi: 10.4103/2394-8108.192520. Epub 2016 Oct 18.
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Other Identifiers
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CEI 144/25
Identifier Type: -
Identifier Source: org_study_id
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