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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| focused shockwave therapy | Active Comparator | this arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with focused shockwave therapy |
|
| radial shockwave therapy | Active Comparator | this arm includes 30 patients with mild to moderate carpal tunnel syndrom who will receive therapy with radial shockwave therapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| radial shock wave therapy | Device | 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 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Numeric Rating Scale | The patient will be asked to categorize his pain and paresthesia on a numeric scale between 0 and 10. | from enrollment until 32 weeks after first shockwave session |
| Boston Carpal Tunnel Questionnaire | Questionnaire to evaluate symptoms and functional restriction in daily activities in patients with CTS | from enrollment until 32 weeks after first shockwave session |
| Measure | Description | Time Frame |
|---|---|---|
| Nerve conduction study parameters | Distal motor latency (DML):The electrode for assessingt he motoric fibers of the median nerve will be applied on the muscle belly of the thenar muscles. The orthodromic motoric stimulation will be performed 6,5 centimeters proxima l to the recording site at the height of the wrist with a single electric impulse. The time between stimulation and the initialincrease of the respondingcompoundm usclea ction potential (CMAP)i s namedt he DML. |
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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:
Patients with bilateral CTS also will be included, whereas the less symptomatic hand will be assessed as well, but receive no therapy.
Exclusion Criteria:
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| focused shock wave therapy | Device | 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 |
|
| from enrollment until 32 weeks after first shockwave session |
| Neurosonography of median nerve |
| from enrollment until 32 weeks after first shockwave session |
| Nerve conduction study parameters | -Sensory nerve conduction velocity: A ring electrode (cathode) is placed on the index finger at the height of the proximal interphalangeal joint. The median nerve will be electrically stimulated antidromically at the same height on the wrist as in DML measurement (approximately 13-14 centimeters proximal to the recording site). For calculation of the nerve conduction velocity, the knowledge of the exact distance between the stimulation and the recording site of the nerve is necessary and therefore will be measure | from enrollment until 32 weeks after first shockwave session |
| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D012046 | Rehabilitation |
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