Carpal Tunnel Syndrome
Conditions
Keywords
platelet rich plasma, extracorporeal shock wave
Brief summary
The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and potential treatment for patients with kinds of musculoskeletal disorders. Although few clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.
Detailed description
We perform a prospective randomized, double-blinded study to investigate the combined effect of PRP and ESWT in patients with carpal tunnel syndrome. Patients were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and one-session active ESWT and control group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.
Interventions
PROCEDUREPlatelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
DEVICEshock wave
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
DOUBLE (Subject, Investigator)
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 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 | Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis. |
Secondary
| 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 | Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain. |
| 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