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Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02986828
Recruitment Status : Recruiting
First Posted : December 8, 2016
Last Update Posted : December 19, 2017
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. 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, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. 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. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

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

Detailed Description:
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline 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 week, 1st, 3rd, 6th month and one year after the treatment.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Long-term Effect of Platelet Rich Plasma and Hydrodissection for Patients With Carpal Tunnel Syndrome
Actual Study Start Date : December 2016
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018


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.
Drug: platelet rich plasma
Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.

Device: Ultrasound
Active Comparator: Normal saline
Normal saline for ultrasound-guided hydrodissection
Drug: Normal saline
Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.

Device: Ultrasound



Primary Outcome Measures :
  1. Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection ]
    Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.


Secondary Outcome Measures :
  1. Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection ]
    Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.

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

  3. Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection ]
    antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.

  4. Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection [ Time Frame: Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection ]
    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
  • Cervical radiculopathy
  • 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): NCT02986828


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

Locations
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
Principal Investigator: Yung-Tsan Wu, MD Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Publications of Results:
Responsible Party: Yung-Tsan Wu, Attending Physician of Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02986828     History of Changes
Other Study ID Numbers: PRP and hydrodissection
First Posted: December 8, 2016    Key Record Dates
Last Update Posted: December 19, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

Keywords provided by Yung-Tsan Wu, Tri-Service General Hospital:
platelet rich plasma
Hydrodissection

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