The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome
The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
1 other identifier
interventional
40
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jun 2016
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 10, 2016
CompletedFirst Posted
Study publicly available on registry
June 15, 2016
CompletedStudy Start
First participant enrolled
June 16, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 15, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 15, 2017
CompletedAugust 2, 2018
July 1, 2018
1.2 years
June 10, 2016
July 31, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary Outcomes (3)
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Study Arms (3)
Platelet rich plasma
EXPERIMENTALThe ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Active shock wave
EXPERIMENTALOne-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Sham shock wave
PLACEBO COMPARATOROne-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Interventions
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
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).
Eligibility Criteria
You may qualify if:
- Age between 20-80 year-old.
- 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.
You may not qualify if:
- Cancer
- Coagulopathy
- Pregnancy
- Inflammation status
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, 886, Taiwan
Related Publications (2)
Malahias MA, Johnson EO, Babis GC, Nikolaou VS. Single injection of platelet-rich plasma as a novel treatment of carpal tunnel syndrome. Neural Regen Res. 2015 Nov;10(11):1856-9. doi: 10.4103/1673-5374.165322.
PMID: 26807124BACKGROUNDWu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113. Epub 2015 Dec 10.
PMID: 26610183RESULT
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Yung-Tsan Wu, MD
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Attending physician of physical medicine and rehabilitation
Study Record Dates
First Submitted
June 10, 2016
First Posted
June 15, 2016
Study Start
June 16, 2016
Primary Completion
September 15, 2017
Study Completion
September 15, 2017
Last Updated
August 2, 2018
Record last verified: 2018-07
Data Sharing
- IPD Sharing
- Will share