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Trial record 77 of 337 for:    Charcot Marie Tooth

Platelet Rich Plasma for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT03184688
Recruitment Status : Recruiting
First Posted : June 14, 2017
Last Update Posted : July 1, 2019
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Brief Summary:
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).

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: platelet rich plasma Drug: Normal saline Not Applicable

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Long-term Effect of Platelet-rich Plasma in Patients With Carpal Tunnel Syndrome: a Prospective Randomized Double-blind Controlled Trial
Actual Study Start Date : September 8, 2017
Estimated Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019


Arm Intervention/treatment
Experimental: platelet rich plasma injection
The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.
Procedure: platelet rich plasma
Ultrasound-guided PRP injection between proximal carpal tunnel and median nerve.

Placebo Comparator: Normal saline
Normal saline for hydrodissection
Drug: Normal saline
Ultrasound-guided normal saline injection between proximal carpal tunnel and median nerve.




Primary Outcome Measures :
  1. Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after the treatment. [ Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. ]
    Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses symptom severity and functional status. Each question ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score ranges from 19 to 95 and the mean of total scores divided with each item score were used for further analysis.


Secondary Outcome Measures :
  1. Change from baseline in severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after the treatment. [ Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. ]
    Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

  2. Change from baseline in cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment. [ Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. ]
    Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.

  3. Change from baseline in conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment. [ Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. ]
    The antidromic sensory nerve conduction velocity of the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.

  4. Change from baseline in finger pinch on 2nd week, 1st, 3rd, 6th month and one year after the treatment. [ Time Frame: Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment. ]
    The finger pinch strength was measured using 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:   Yes
Criteria

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

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): NCT03184688


Contacts
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Contact: Yung-Tsan Wu, MD 886-2-87923311 ext 17068 crwu98@gmail.com

Locations
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Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital Recruiting
Taipei, Neihu District, Taiwan, 886
Contact: Yung-Tsan Wu, MD    886-2-8792-3311 ext 17068    crwu98@gmail.com   
Sponsors and Collaborators
Tri-Service General Hospital
Investigators
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Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
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Responsible Party: Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT03184688     History of Changes
Other Study ID Numbers: Perineural PRP for CTS
First Posted: June 14, 2017    Key Record Dates
Last Update Posted: July 1, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
platelet rich plasma
Perineural injection therapy
hydrodissection
Additional relevant MeSH terms:
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Nerve Compression Syndromes
Carpal Tunnel Syndrome
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