The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

NCT ID: NCT02800200

Last Updated: 2018-08-02

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-16

Study Completion Date

2017-09-15

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Carpal Tunnel Syndrome

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Platelet rich plasma

The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type PROCEDURE

Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

shock wave

Intervention Type DEVICE

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.

Group Type EXPERIMENTAL

Platelet rich plasma

Intervention Type PROCEDURE

Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

shock wave

Intervention Type DEVICE

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.

Group Type PLACEBO_COMPARATOR

Platelet rich plasma

Intervention Type PROCEDURE

Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

shock wave

Intervention Type DEVICE

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.

Intervention Type PROCEDURE

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).

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tri-Service General Hospital

OTHER

Sponsor Role lead

Responsible Party

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Yung-Tsan Wu

Attending physician of physical medicine and rehabilitation

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Taiwan

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.

Reference Type BACKGROUND
PMID: 26807124 (View on PubMed)

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.

Reference Type RESULT
PMID: 26610183 (View on PubMed)

Other Identifiers

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TSGHIRB No: 2-105-05-026

Identifier Type: -

Identifier Source: org_study_id

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