NCT02696161

Platelet Rich Plasma and Perineural Injection Therapy for Carpal Tunnel Syndrome

The Long-term Effect of Platelet Rich Plasma and Perineural Injection Therapy in Patients With Carpal Tunnel Syndrome

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Tri-Service General Hospital · Academic / Other
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Accepted

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, two small clinical trials showed the positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective effect against neurological deficit of facial nerve during superficial parotidectomy. 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. In addition, the PRP was not used for treating CTS so far. 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 of clinically diagnosed with CTS were randomized into intervention and control group. Participants in intervention group received one-dose ultrasound-guided PRP injection and control group received one-dose ultrasound-guided 5% dextrose injection. No additional treatment after injection through the study period. The primary outcome is visual analog scale (VAS) and secondary outcomes include Boston Carpal Tunnel Syndrome Questionnaire (BCTQ), 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, 4th, 8th, 12th, 16th and 24th week after the treatment.

Conditions

• Carpal Tunnel Syndrome

Interventions

Type	Name	Description
OTHER	platelet rich plasma	Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
OTHER	5% dextrose	Ultrasound-guided 3cc 5% dextrose injection between proximal carpal tunnel and median nerve.

Timeline

• Start date: 2016-02-01
• Primary completion: 2017-07-31
• Completion: 2017-07-31
• First posted: 2016-03-02
• Last updated: 2019-06-19

Locations

1 site across 1 country: Taiwan