Carpal Tunnel Syndrome
Conditions
Keywords
focused extracorporeal shock wave therapy
Brief summary
The carpal tunnel syndrome (CTS) is the most common entrapment neuropathy in the general population.The focus extracorporeal shock wave (fEWST) is a non invasive treatment for various diseases. FESWT is new and potential treatment for peripheral nerve entrapment/ peripheral neuropathy . But there is still little known about the effects and long term effects of fESWT in the treatment of CTS.
Detailed description
The aim of this study is to determine the effectiveness of fESWT in patients with carpal tunnel syndrome compared to participants receiving only night splint. Therefore 40 patients with mild to moderate CTS (verified by nerve conduction velocity) will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints. Evaluation will be performed at baseline (VAS, hand grip, electrodiagnostic parameters, questionnaires), 3 weeks (VAS, hand grip, questionnaires), 12 and 24 weeks (VAS, hand grip, electrodiagnostic parameters, questionnaires) after treatment.
Interventions
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
OTHERsham focused extracorporeal shock wave therapy
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
OTHERnight splint
40 Patients with mild to moderate CTS will be randomized to receive either fESWT (1-session a week for 3 weeks) or sham fESWT(1-session a week for 3 weeks). All subjects will be asked to wear night splints.
Sponsors
Medical University of Vienna
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
\- mild to moderate CTS verified by nerve conduction velocity
Exclusion criteria
* metabolic diseases * blood clotting problems * systemic diseases * polyneuropathy * chemotherapy during the study * corticosteroid therapy * use of anticoagulation * history of trauma/surgery or nerve lesion of the teated extremity * CTS surgery on the affected hand * ICD/ pacemaker implantation * other therapy for the affected hand during the study * acute inflammation or infections * severe mental illnesses/psychiatric diseases * severe neurological diseases
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| VAS | baseline, 3th,12th and 24th weeks after treatment | Visual Analog Scale: Change from baseline of pain 3th,12th and 24th weeks after treatment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| hand grip strength | baseline, 3th,12th and 24th weeks after treatment | hand grip strength: |
| distal motor latency of the median nerve | baseline,12th and 24th weeks after treatment | electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment. |
| sensory conduction velocity of the median nerve | baseline, 12th and 24th weeks after treatment | electrophysiological parameter, using nerve conduction velocity to measure distal motor latency and antidromic sensory nerve conduction velocity of the median nerve. Change from baseline in conduction velocity of median nerve on 12th and 24th weeks after treatment. |
| SF-36 | baseline, 3th,12th and 24th weeks after treatment | 36-item Short Form Health Survey: Change from baseline in quality of life 3th,12th and 24th weeks after treatment. |
| Boston Scale | baseline, 3th,12th and 24th weeks after treatment | Boston Symptom Severity Score: Change from baseline in severity of symptoms and functional status 3th,12th and 24th weeks after treatment. |
Countries
Austria
Contacts
Primary ContactChristina Gesslbauer, Dr.
Backup ContactChristina Gesslbauer
Outcome results
None listed