The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: Platelet rich plasma
* Device: shock wave


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 year-old. 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: Cancer Coagulopathy Pregnancy Inflammation status 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Platelet rich plasma<br>The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups. | Procedure: Platelet rich plasma<br>* Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.<br>Device: shock wave<br>* 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).<br>|
| Experimental: Active shock wave<br>One-session active shock wave 2 weeks later after PRP injection was performed in intervention group. | Procedure: Platelet rich plasma<br>* Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.<br>Device: shock wave<br>* 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).<br>|
| Placebo Comparator: Sham shock wave<br>One-session sham shock wave 2 weeks later after PRP injection was performed in control group. | Procedure: Platelet rich plasma<br>* Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.<br>Device: shock wave<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, extracorporeal shock wave