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The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
Platelet rich plasma
shock wave
Sponsored by
Tri-Service General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Carpal Tunnel Syndrome focused on measuring platelet rich plasma, extracorporeal shock wave

Eligibility Criteria

20 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Platelet rich plasma

Active shock wave

Sham shock wave

Arm Description

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

One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.

One-session sham shock wave 2 weeks later after PRP injection was performed in control group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks
electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).

Full Information

First Posted
June 10, 2016
Last Updated
July 31, 2018
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02800200
Brief Title
The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome
Official Title
The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
June 16, 2016 (Actual)
Primary Completion Date
September 15, 2017 (Actual)
Study Completion Date
September 15, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tri-Service General Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carpal Tunnel Syndrome
Keywords
platelet rich plasma, extracorporeal shock wave

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Platelet rich plasma
Arm Type
Experimental
Arm Description
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Arm Title
Active shock wave
Arm Type
Experimental
Arm Description
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Arm Title
Sham shock wave
Arm Type
Placebo Comparator
Arm Description
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Intervention Type
Procedure
Intervention Name(s)
Platelet rich plasma
Intervention Description
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.
Intervention Type
Device
Intervention Name(s)
shock wave
Intervention Description
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 Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
Description
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.
Time Frame
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary Outcome Measure Information:
Title
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.
Description
Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Time Frame
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Title
Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Time Frame
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Title
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks
Description
electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).
Time Frame
Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yung-Tsan Wu, MD
Organizational Affiliation
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
City
Taipei
State/Province
Neihu District
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
Yes
Citations:
PubMed Identifier
26807124
Citation
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.
Results Reference
background
PubMed Identifier
26610183
Citation
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.
Results Reference
result

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The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

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