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Clinical Efficiency Testing of Extracorporeal Radial and Focused Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome

NCT06912893 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-04-06

No results posted yet for this study

Summary

The aim of the project is to test the efficacy of extracorporeal shock wave therapy (radial + focused) on clinical outcomes in patients with carpal tunnel syndrome (CTS). Shock wave therapy has already been shown to be potentially effective in the literature. However, no studies are known to date that test both shock wave types in one protocol, and the follow-up period in the previous studies was set at a maximum of 24 weeks.

Consequently, this study is planned as a multicenter, prospective, randomized, investigator-blinded study. 60 subjects will be assigned to the two shock wave types, and the follow-up period is scheduled for 32 weeks.

The study will be conducted at the Institute for Physical Medicine and Rehabilitation at the University Hospital Krems and St. Pölten. Recruitment will take place through the respective CTS outpatient clinics of the departments, as well as through private practice (orthopedists, general practitioners, neurologists, etc.). The inclusion and exclusion criteria are checked before the subject is included in the study, with nerve conduction velocity (NCV) being emphasized as a diagnostic method.

After the patient is included in the study or signs the consent form, the relevant demographic, medical, and personal data are collected (pseudonymized procedure). Study-related measurements are then performed (nerve sonography, Boston Carpal Tunnel Questionnaire, Visual Analog Scale). The baseline examinations and follow-up examinations are each performed by the same physician (blinded), while the subsequent shock wave therapy is performed by a second physician.

After the baseline examinations, the patient is randomly assigned to one of the two shock wave groups and receives five shock wave therapy sessions one week apart. The pulses and frequency of both treatments are identical (2000 and 5 Hz, respectively). The intensity is xx bar in the radial group and 0.05 mj/mm² in the focused group.

Detailed follow-up assessments, including all baseline measurements, will be conducted 16 and 32 weeks after the first shock wave therapy. At weeks 8 and 24, a questionnaire (Boston Carpal Tunnel Questionnaire; VAS) will also be sent to the patient.

Patients with bilateral clinical CTS will serve as the control group. In this case, the more symptomatic hand will be assigned to a shock wave treatment group, while the other hand will serve as a control. This means no treatment, but all measurements will be performed in the same way as in the study groups.

Conditions

  • Carpal Tunnel Syndrome (CTS)

Interventions

DEVICE

radial shock wave therapy

treatment of the nervus medianus on the level of the carpal tunnel with radial shock wave therapy with 1500 impulses, 5 Hz and 1,5 bar

DEVICE

focused shock wave therapy

treatment of the nervus medianus on the level of the carpal tunnel with focused shock wave therapy with 1500 impulses, 5 Hz and 0,05 mJ/mm²

Sponsors & Collaborators

  • University Hospital St. Polten

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-01
Primary Completion
2027-11-01
Completion
2028-11-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06912893 on ClinicalTrials.gov