Platelet Rich Plasma for Carpal Tunnel Syndrome

Study Overview
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Brief Summary
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Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, four small clinical trials showed the positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of PRP for peripheral neuropathy from currently published studies is unclarified because these studies enrolled a few patients and lacked long-term follow-up (no more than 6 months follow-up).

Detailed Description
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After obtaining written informed consent, patients of clinically diagnosed with bilateral CTS were randomized into intervention and control side. Intervention group received one-dose ultrasound-guided PRP injection and control group received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year after the treatment.

Official Title
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The Long-term Effect of Platelet-rich Plasma in Patients With Carpal Tunnel Syndrome: a Prospective Randomized Double-blind Controlled Trial

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Procedure: platelet rich plasma
* Drug: Normal saline


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 year-old. Diagnosis was confirmed using an electrophysiological study Exclusion Criteria: Cancer Coagulopathy Pregnancy Inflammation status Polyneuropathy, brachial plexopathy Thoracic outlet syndrome 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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Accepts Healthy Volunteers

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: platelet rich plasma injection<br>The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies. | Procedure: platelet rich plasma<br>* Ultrasound-guided PRP injection between proximal carpal tunnel and median nerve.<br>|
| Placebo Comparator: Normal saline<br>Normal saline for hydrodissection | Drug: Normal saline<br>* Ultrasound-guided normal saline injection between proximal carpal tunnel and median nerve.<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 2nd week, 1st, 3rd, 6th month and one year after the treatment. | Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses symptom severity and functional status. Each question ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score ranges from 19 to 95 and the mean of total scores divided with each item score were used for further analysis. | Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after the treatment. | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. | Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. | 
| Change from baseline in cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment. | Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve. | Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. | 
| Change from baseline in conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment. | The antidromic sensory nerve conduction velocity of the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode. | Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. | 
| Change from baseline in finger pinch on 2nd week, 1st, 3rd, 6th month and one year after the treatment. | The finger pinch strength was measured using 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 | Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, Perineural injection therapy, hydrodissection