The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome
NCT ID: NCT02800200
Last Updated: 2018-08-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-06-16
2017-09-15
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Platelet rich plasma
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
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).
Active shock wave
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
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).
Sham shock wave
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
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).
Interventions
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Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
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).
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
85 Years
ALL
No
Sponsors
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Tri-Service General Hospital
OTHER
Responsible Party
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Yung-Tsan Wu
Attending physician of physical medicine and rehabilitation
Principal Investigators
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Yung-Tsan Wu, MD
Role: PRINCIPAL_INVESTIGATOR
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Locations
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Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
Taipei, Neihu District, Taiwan
Countries
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References
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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.
Wu 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.
Other Identifiers
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TSGHIRB No: 2-105-05-026
Identifier Type: -
Identifier Source: org_study_id
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