The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare.

Detailed Description
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The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare. We performe a prospective study to investigate the effect of PRP in patients with carpal tunnel syndrome. Patients with carpal tunnel syndrome (CTS) were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and control group received night splint. The evaluation was performed pretreatment as well as on the 1st, 4th, 8th, 12th, 16th and 24 week after the treatment.

Official Title
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The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Biological: platelet rich plasma
* Device: splint


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: 80 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet rich plasma<br>Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group. | Biological: platelet rich plasma<br>* Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve<br>|
| Active Comparator: splinting<br>The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study in control group. | Device: splint<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | Visual analog scale (VAS) | 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks | Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment. | Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | 
| Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks | Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve. | Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | 
| Change from baseline of electrophysiological study on 1st, 2nd, 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, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. | 
| Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks | The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch | Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. |