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The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

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ClinicalTrials.gov Identifier: NCT02800200
Recruitment Status : Completed
First Posted : June 15, 2016
Last Update Posted : April 25, 2018
Sponsor:
Information provided by (Responsible Party):
Yung-Tsan Wu, Tri-Service General Hospital

Brief Summary:
The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and potential treatment for patients with kinds of musculoskeletal disorders. Although few clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.

Condition or disease Intervention/treatment Phase
Carpal Tunnel Syndrome Procedure: Platelet rich plasma Device: shock wave Not Applicable

Detailed Description:

We perform a prospective randomized, double-blinded study to investigate the combined effect of PRP and ESWT in patients with carpal tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and one-session active ESWT and control group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.


Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Actual Study Start Date : June 16, 2016
Actual Primary Completion Date : September 15, 2017
Actual Study Completion Date : September 15, 2017


Arm Intervention/treatment
Experimental: Platelet rich plasma
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Procedure: Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

Device: shock wave
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).

Experimental: Active shock wave
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Procedure: Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

Device: shock wave
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).

Placebo Comparator: Sham shock wave
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Procedure: Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

Device: shock wave
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 μs).




Primary Outcome Measures :
  1. Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment. [ Time Frame: Pre-treatment, 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 on 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 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 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 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 4th, 8th, 12th, 16th and 24th weeks [ Time Frame: Pre-treatment, 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).



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Ages Eligible for Study:   20 Years to 85 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): NCT02800200


Locations
Taiwan
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 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 of Results:
Other Publications:
Responsible Party: Yung-Tsan Wu, Attending physician of physical medicine and rehabilitation, Tri-Service General Hospital
ClinicalTrials.gov Identifier: NCT02800200     History of Changes
Other Study ID Numbers: TSGHIRB No: 2-105-05-026
First Posted: June 15, 2016    Key Record Dates
Last Update Posted: April 25, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes

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

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