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The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02539186
Recruitment Status : Completed
First Posted : September 2, 2015
Last Update Posted : October 11, 2017
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

August 31, 2015
September 2, 2015
October 11, 2017
August 2015
September 2017   (Final data collection date for primary outcome measure)
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)
Same as current
Complete list of historical versions of study NCT02539186 on ClinicalTrials.gov Archive Site
  • Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. ]
    Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
  • Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. ]
    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
  • Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. ]
    electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).
  • Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment. ]
    The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch
Same as current
Not Provided
Not Provided
 
The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome
The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome
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.

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.

Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Carpal Tunnel Syndrome
  • Biological: platelet rich plasma
    Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve
  • Device: splint
  • Experimental: platelet rich plasma
    Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group.
    Intervention: Biological: platelet rich plasma
  • Active Comparator: splinting
    The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study in control group.
    Intervention: Device: splint

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
60
50
September 2017
September 2017   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  1. Age between 20-80 year-old.
  2. 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:

  1. Cancer
  2. Coagulopathy
  3. Pregnancy
  4. Inflammation status
  5. 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.
Sexes Eligible for Study: All
20 Years to 80 Years   (Adult, Older Adult)
No
Contact information is only displayed when the study is recruiting subjects
Taiwan
 
 
NCT02539186
TSGHIRB No: 1-104-05-108
Yes
Not Provided
Not Provided
Yung-Tsan Wu, Tri-Service General Hospital
Tri-Service General Hospital
Not Provided
Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Tri-Service General Hospital
October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP