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
| Type | Name | Description |
|---|---|---|
| PROCEDURE | platelet rich plasma | Ultrasound-guided PRP injection between proximal carpal tunnel and median nerve. |
| DRUG | Normal saline | Ultrasound-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.