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Platelet Rich Plasma for Carpal Tunnel Syndrome

T

Tri-Service General Hospital

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Drug: Normal saline
Procedure: platelet rich plasma

Study type

Interventional

Funder types

Other

Identifiers

NCT03184688
Perineural PRP for CTS

Details and patient eligibility

About

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).

Full 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.

Enrollment

26 patients

Sex

All

Ages

20 to 80 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion criteria

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

26 participants in 2 patient groups, including a placebo group

platelet rich plasma injection
Experimental group
Description:
The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.
Treatment:
Procedure: platelet rich plasma
Normal saline
Placebo Comparator group
Description:
Normal saline for hydrodissection
Treatment:
Drug: Normal saline

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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