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Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

Primary Purpose

Carpal Tunnel Syndrome

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
platelet rich plasma
Normal saline
Ultrasound
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, Hydrodissection

Eligibility Criteria

20 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Age between 20-80 year-old.
  • Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • 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 Type

Experimental

Active Comparator

Arm Label

platelet rich plasma injection

Normal saline

Arm Description

The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.

Normal saline for ultrasound-guided hydrodissection

Outcomes

Primary Outcome Measures

Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.

Secondary Outcome Measures

Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection
The finger pinch strength was measured using 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
December 6, 2016
Last Updated
October 29, 2019
Sponsor
Tri-Service General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT02986828
Brief Title
Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome
Official Title
The Long-term Effect of Platelet Rich Plasma and Hydrodissection for Patients With Carpal Tunnel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
December 1, 2016 (Actual)
Primary Completion Date
October 30, 2019 (Actual)
Study Completion Date
October 30, 2019 (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
Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. Rather than other progressive disease, CTS is characterized by remission and recurrence. Although many conservative managements of CTS, the effectiveness of these methods is insignificant or only persist for a short duration. The platelet rich plasma (PRP) is a new and potential treatment for patients with kinds of musculoskeletal disorders and recent reports showed being beneficial for peripheral neuropathy in animal studies. Since 2014, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. However, these studies have not entirely proved the effects of PRP on peripheral neuropathy because these studies enrolled small number of patients and lacked controlled design. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.
Detailed Description
After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side received one-dose ultrasound-guided normal saline injection. No additional treatment after injection through the study period. The primary outcome is Boston Carpal Tunnel Syndrome Questionnaire (BCTQ) and secondary outcomes include visual analog scale (VAS), cross-sectional area (CSA) of the median nerve, sensory nerve conduction velocity of the median nerve, and finger pinch strength. The evaluation was performed pretreatment as well as on the 2nd week, 1st, 3rd, 6th month and one year 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, Hydrodissection

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
platelet rich plasma injection
Arm Type
Experimental
Arm Description
The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.
Arm Title
Normal saline
Arm Type
Active Comparator
Arm Description
Normal saline for ultrasound-guided hydrodissection
Intervention Type
Drug
Intervention Name(s)
platelet rich plasma
Intervention Description
Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Intervention Description
Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.
Intervention Type
Device
Intervention Name(s)
Ultrasound
Primary Outcome Measure Information:
Title
Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Description
Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Secondary Outcome Measure Information:
Title
Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Description
Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Title
Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Description
Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Title
Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Description
antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.
Time Frame
Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Title
Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection
Description
The finger pinch strength was measured using 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, 2nd week, 1st, 3rd, 6th month and 1 year after injection

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age between 20-80 year-old. Diagnosis was confirmed using an electrophysiological study Exclusion Criteria: Cancer Coagulopathy Pregnancy Inflammation status Cervical radiculopathy Polyneuropathy, brachial plexopathy Thoracic outlet syndrome 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
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
24168291
Citation
Anjayani S, Wirohadidjojo YW, Adam AM, Suwandi D, Seweng A, Amiruddin MD. Sensory improvement of leprosy peripheral neuropathy in patients treated with perineural injection of platelet-rich plasma. Int J Dermatol. 2014 Jan;53(1):109-13. doi: 10.1111/ijd.12162. Epub 2013 Oct 29.
Results Reference
result
PubMed Identifier
23519544
Citation
Sanchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.
Results Reference
result
PubMed Identifier
24425846
Citation
Scala M, Mereu P, Spagnolo F, Massa M, Barla A, Mosci S, Forno G, Ingenito A, Strada P. The use of platelet-rich plasma gel in patients with mixed tumour undergoing superficial parotidectomy: a randomized study. In Vivo. 2014 Jan-Feb;28(1):121-4.
Results Reference
result
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
result

Learn more about this trial

Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

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