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Clinical Trials/NCT02539186
NCT02539186
Completed
Not Applicable

The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome

Tri-Service General Hospital1 site in 1 country60 target enrollmentAugust 2015

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Carpal Tunnel Syndrome
Sponsor
Tri-Service General Hospital
Enrollment
60
Locations
1
Primary Endpoint
Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Status
Completed
Last Updated
8 years ago

Overview

Brief Summary

The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare.

Detailed Description

The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare. We performe a prospective study to investigate the effect of PRP in patients with carpal tunnel syndrome. Patients with carpal tunnel syndrome (CTS) were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and control group received night splint. The evaluation was performed pretreatment as well as on the 1st, 4th, 8th, 12th, 16th and 24 week after the treatment.

Registry
clinicaltrials.gov
Start Date
August 2015
End Date
September 2017
Last Updated
8 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Yung-Tsan Wu

Attending physician

Tri-Service General Hospital

Eligibility Criteria

Inclusion Criteria

  • Age between 20-80 year-old.
  • Typical symptoms and signs of CTS, such as positive Tinel's sign or Phalen's test, numbness/tingling in at least two of the first, second, or third digits, and in whom the diagnosis was confirmed using an electrophysiological study.

Exclusion Criteria

  • Coagulopathy
  • Inflammation status
  • Patients who had conditions mimicking CTS, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for CTS.

Outcomes

Primary Outcomes

Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

Time Frame: 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

Visual analog scale (VAS)

Secondary Outcomes

  • Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
  • Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
  • Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)
  • Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks(Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.)

Study Sites (1)

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