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

Official title

Efficacy of Radial and Focused Extracorporeal Shockwave Therapy in Patients Wirh Carpal Tunnel Syndrom. a Multicentric, Randomised Observer-blinded Trial

Overview

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.

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

Primary outcome measures

• Numeric Rating Scale [Time frame: from enrollment until 32 weeks after first shockwave session]
• Boston Carpal Tunnel Questionnaire [Time frame: from enrollment until 32 weeks after first shockwave session]

Secondary outcome measures (3)

• Nerve conduction study parameters [Time frame: from enrollment until 32 weeks after first shockwave session]
• Neurosonography of median nerve [Time frame: from enrollment until 32 weeks after first shockwave session]
• Nerve conduction study parameters [Time frame: from enrollment until 32 weeks after first shockwave session]

Eligibility criteria

Inclusion criteria

• Patients of all genders
• aged above 18 years
• suffering from mild to moderate carpal tunnel syndrome with typical symptoms like pain, paresthesia, or fine motoric disorders:

• very mild (grade 1): sensory nerve conduction velocity mildly reduced orslowercompared to the contralateral side.
• mild (grade 2): distal motor latency <4,5ms and sensory nerve conduction velocity < 40 m/s
• moderate (grade 3): distal motor latency between 4,5 and 6,5 ms and preserved sensory nerve amplitude.
• Patients with bilateral CTS also will be included, whereas the less symptomatic hand will be assessed as well, but receive no therapy.

Exclusion criteria

• Patients with severe CTS (distal motor latency above 6,5ms or absent sensory potentials);
• Prior therapy (even night splints) for CTS within the last six months
• The presence of common systemic diseases, that have known influence on the peripheral nerve system, like diabetes mellitus, polyneuropathy orabusive C2 consumption
• Postsurgical CTS
• Patients with serious injury of the wrist in medical history (e.g. radius fracture) or previous damage to median nerve and more proximal located compression syndrome of median nerve
• Patients with implanted electronic devices like defibrillators or pacemakers
• Pregnant women
• bifid median nerve;

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06912893 · GS3-EK-1/222-2024

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗