Platelet Rich Plasma and Hydrodissection 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. Rather than other progressive disease, CTS is characterized by remission and recurrence. 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, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

Detailed Description
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After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side 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 and Hydrodissection for Patients With Carpal Tunnel Syndrome

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Drug: platelet rich plasma
* Drug: Normal saline
* Device: Ultrasound


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 Cervical radiculopathy 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: Double


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. | Drug: platelet rich plasma<br>* Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.<br>Device: Ultrasound<br> <br> |
| Active Comparator: Normal saline<br>Normal saline for ultrasound-guided hydrodissection | Drug: Normal saline<br>* Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.<br>Device: Ultrasound<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 2nd week, 1st, 3rd, 6th month and 1 year after injection | Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection | Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | 
| Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection | Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | 
| Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection | antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment. | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | 
| Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection | 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 | Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet rich plasma, Hydrodissection