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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

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.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Biological: platelet rich plasma Device: splint Not Applicable

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.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Official Title: The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome
Actual Study Start Date : August 2015
Actual Primary Completion Date : September 2017
Actual Study Completion Date : September 2017


Arm Intervention/treatment
Experimental: platelet rich plasma
Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group.
Biological: platelet rich plasma
Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve

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.
Device: splint



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

  2. 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.

  3. 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).

  4. 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



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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02539186


Locations
Taiwan
Tri-Service General Hospital
Taipei, Neihu, Taiwan, 886
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center

Publications:
Responsible Party: Yung-Tsan Wu, Attending physician, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02539186     History of Changes
Other Study ID Numbers: TSGHIRB No: 1-104-05-108
First Posted: September 2, 2015    Key Record Dates
Last Update Posted: October 11, 2017
Last Verified: October 2017

Additional relevant MeSH terms:
Nerve Compression Syndromes
Syndrome
Carpal Tunnel Syndrome
Disease
Pathologic Processes
Median Neuropathy
Mononeuropathies
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases
Cumulative Trauma Disorders
Sprains and Strains
Wounds and Injuries