Carpal Tunnel Syndrome
Conditions
Keywords
Carpal Tunnel Syndrome, Extracorporeal shock wave
Brief summary
Extracorporeal shock wave is a novel treatment for peripheral nerve entrapment. This study was designed to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.
Detailed description
Both focused and radial extracorporeal shock wave had been proved to treat carpal tunnel syndrome by several studies. However, there was no study comparing these two methods. Considering different mechanisms and costs, this randomized comparative trial would be conducted to compare the efficacy of focused and radial extracorporeal shock wave for carpal tunnel syndrome.
Interventions
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (\< 10 ns) and short duration (10 μs). Different studies and clinical experiments have demonstrated the efficacy of shock waves in the treatment of musculoskeletal system such as chronic tendinopathies or hypertrophic pseudoarthrosis.
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Clinical and electrophysiological diagnosis of CTS
Exclusion criteria
* Cervical radiculopathy * Polyneuropathy * Brachial plexopathy * Thoracic outlet syndrome * Previous wrist surgery or steroid injection for CTS
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) at 24th weeks after treatment | Change of the mean of total SSS and FSS from baseline at 24th weeks after treatment | Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses two components. eleven questions and eight items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Each question or item ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score of SSS ranges from 11-55 and FSS from 8-40. The mean of total SSS and FSS divided with each item score were used for further analysis. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Visual analogue scale (VAS) | Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment | Digital pain severity or paresthesia/dysthesia within 1 week prior to evaluation was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain. |
| Nerve conduction velocity | Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment | Change from baseline in conduction velocity of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment. |
| Cross-sectional area (CSA) of the median nerve | Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment | Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th and 24th weeks after treatment. |
| Nerve conduction amplitude | Pre-treatment, 2nd, 4th, 8th, 12th and 24th weeks after treatment | Change from baseline in conduction amplitude of median nerve on 2nd, 4th, 8th,12th and 24th weeks after treatment. |
Countries
Taiwan
Outcome results
None listed