Platelet Rich Plasma and Perineural Injection Therapy for Carpal Tunnel Syndrome

T

Tri-Service General Hospital

Status

Completed

Conditions

Carpal Tunnel Syndrome

Treatments

Other: platelet rich plasma
Other: 5% dextrose

Study type

Interventional

Funder types

Other

Identifiers

NCT02696161
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. 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.

Full 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.

Enrollment

52 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
  • Cervical radiculopathy
  • 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

Double Blind

52 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:
Other: platelet rich plasma
5% dextrose
Placebo Comparator group
Description:
5% dextrose for hydrodissection
Treatment:
Other: 5% dextrose

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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