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The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet rich plasma
splint
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

Eligibility Criteria

20 Years - 80 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

  • Tri-Service General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

platelet rich plasma

splinting

Arm Description

Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group.

The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study in control group.

Outcomes

Primary Outcome Measures

Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Visual analog scale (VAS)

Secondary Outcome Measures

Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 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 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).
Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch

Full Information

First Posted
August 31, 2015
Last Updated
October 10, 2017
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02539186
Brief Title
The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome
Official Title
The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (Actual)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 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) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare.
Detailed Description
The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders. Although few studies have showed beneficial effect of PRP for regeneration of peripheral neuropathy in animal study, the associated study in human is rare. We performe a prospective study to investigate the effect of PRP in patients with carpal tunnel syndrome. Patients with carpal tunnel syndrome (CTS) were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and control group received night splint. The evaluation was performed pretreatment as well as on the 1st, 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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
platelet rich plasma
Arm Type
Experimental
Arm Description
Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group.
Arm Title
splinting
Arm Type
Active Comparator
Arm Description
The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study in control group.
Intervention Type
Biological
Intervention Name(s)
platelet rich plasma
Intervention Description
Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve
Intervention Type
Device
Intervention Name(s)
splint
Primary Outcome Measure Information:
Title
Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Description
Visual analog scale (VAS)
Time Frame
1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Secondary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
Description
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Title
Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 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, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Title
Change from baseline of electrophysiological study on 1st, 2nd, 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, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Title
Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
Description
The finger pinch strength was measured using Jamar dynamometer (Fabrication Enterprises Inc., USA). The subject was seated with shoulder adducted and neutrally rotated with the elbow flexed at 90°. The forearm and wrist were positioned in a neutral position for the palmar pinch
Time Frame
Pre-treatment, 1st, 2nd, 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
80 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
Tri-Service General Hospital
City
Taipei
State/Province
Neihu
ZIP/Postal Code
886
Country
Taiwan

12. IPD Sharing Statement

Citations:
PubMed Identifier
25230270
Citation
Kucuk L, Gunay H, Erbas O, Kucuk U, Atamaz F, Coskunol E. Effects of platelet-rich plasma on nerve regeneration in a rat model. Acta Orthop Traumatol Turc. 2014;48(4):449-54. doi: 10.3944/AOTT.2014.13.0029.
Results Reference
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PubMed Identifier
23723151
Citation
Zheng C, Zhu Q, Liu X, Huang X, He C, Jiang L, Quan D, Zhou X, Zhu Z. Effect of platelet-rich plasma (PRP) concentration on proliferation, neurotrophic function and migration of Schwann cells in vitro. J Tissue Eng Regen Med. 2016 May;10(5):428-36. doi: 10.1002/term.1756. Epub 2013 May 31.
Results Reference
background
PubMed Identifier
23640879
Citation
Lichtenfels M, Colome L, Sebben AD, Braga-Silva J. Effect of Platelet Rich Plasma and Platelet Rich Fibrin on sciatic nerve regeneration in a rat model. Microsurgery. 2013 Jul;33(5):383-90. doi: 10.1002/micr.22105. Epub 2013 May 2.
Results Reference
background
PubMed Identifier
23558771
Citation
Park GY, Kwon DR. Platelet-rich plasma limits the nerve injury caused by 10% dextrose in the rabbit median nerve. Muscle Nerve. 2014 Jan;49(1):56-60. doi: 10.1002/mus.23863. Epub 2013 Sep 20.
Results Reference
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The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

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