Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Drug: Normal saline; Drug: platelet rich plasma; Device: Ultrasound

• Registration Number: NCT02986828
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2016-12-01
• Study First Submitted: 2016-12-06
• Study First Submitted QC: 2016-12-07
• Study First Posted: 2016-12-08
• Status Verified: 2019-10
• Last Update Submitted: 2019-10-29
• Primary Completion: 2019-10-30
• Study Completion: 2019-10-30
• Last Update Posted: 2019-10-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 26

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Normal saline	Ultrasound	Normal saline for ultrasound-guided hydrodissection
platelet rich plasma injection	Ultrasound	The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.
Normal saline	Normal saline	Normal saline for ultrasound-guided hydrodissection
platelet rich plasma injection	platelet rich plasma	The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.

Primary Outcome Measures

Name	Time	Method
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Pre-treatment, 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.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Pre-treatment, 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.
Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Pre-treatment, 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
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Pre-treatment, 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.
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Pre-treatment, 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.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan