Clinical Trials Directory

Trials / Completed

CompletedNCT03184688

Platelet Rich Plasma for Carpal Tunnel Syndrome

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

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
26 (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. 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

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREplatelet rich plasmaUltrasound-guided PRP injection between proximal carpal tunnel and median nerve.
DRUGNormal salineUltrasound-guided normal saline injection between proximal carpal tunnel and median nerve.

Timeline

Start date
2017-09-08
Primary completion
2019-10-30
Completion
2019-10-30
First posted
2017-06-14
Last updated
2019-10-31

Locations

1 site across 1 country: Taiwan

Source: ClinicalTrials.gov record NCT03184688. Inclusion in this directory is not an endorsement.