Carpal Tunnel Syndrome
Conditions
Brief summary
The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.
Detailed description
The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.
Interventions
DEVICEESWT
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).
Sponsors
Tri-Service General Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
20 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
1. Age between 20-80 year-old. 2. Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.
Exclusion criteria
1. Cancer 2. Coagulopathy 3. Pregnancy 4. Inflammation status 5. Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment. | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment | Visual analog scale (VAS) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment | Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment. |
| Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment | Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve. |
| Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment | electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). |
Countries
Taiwan
Outcome results
None listed