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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Platelet rich plasma | Experimental | The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups. |
|
| Active shock wave | Experimental | One-session active shock wave 2 weeks later after PRP injection was performed in intervention group. |
|
| Sham shock wave | Placebo Comparator | One-session sham shock wave 2 weeks later after PRP injection was performed in control group. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet rich plasma | Procedure | Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks | 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. | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of pain on 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. | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Yung-Tsan Wu, MD | Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital | Taipei | Neihu District | 886 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26807124 | Background | Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322. | |
| 26610183 | Result | Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10. |
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| ID | Term |
|---|---|
| D002349 | Carpal Tunnel Syndrome |
| ID | Term |
|---|---|
| D020423 | Median Neuropathy |
| D020422 | Mononeuropathies |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
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| ID | Term |
|---|---|
| D000074059 | Extracorporeal Shockwave Therapy |
| ID | Term |
|---|---|
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
| D013812 | Therapeutics |
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| shock wave | Device | 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). |
|
| Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks |
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve. |
| Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment |
| Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks | electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA). | Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment |
| D009422 | Nervous System Diseases |
| D009408 | Nerve Compression Syndromes |
| D012090 | Cumulative Trauma Disorders |
| D013180 | Sprains and Strains |
| D014947 | Wounds and Injuries |
| D026741 |
| Physical Therapy Modalities |
| D012046 | Rehabilitation |