NCT02696161

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, two small clinical trials showed the positive effect of PRP in peripheral neuropathy. One study shown the PRP has therapeutic effect for peripheral neuropathy in patients with leprosy. In addition, PRP having protective effect against neurological deficit of facial nerve during superficial parotidectomy. 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. In addition, the PRP was not used for treating CTS so far. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

February 22, 2016

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 2, 2016

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 31, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 31, 2017

Completed
Last Updated

June 19, 2019

Status Verified

June 1, 2019

Enrollment Period

1.5 years

First QC Date

February 22, 2016

Last Update Submit

June 18, 2019

Conditions

Carpal Tunnel Syndrome

Keywords

platelet rich plasmaPerineural injection therapy

Outcome Measures

Primary Outcomes (1)

  • Change from baseline in severity of symptoms and functional status on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    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.

    Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

Secondary Outcomes (3)

  • Change from baseline in cross-sectional area of the median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

  • Change from baseline in conduction velocity, amplitude of median nerve on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

  • Change from baseline in finger pinch on 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

    Pre-treatment, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

Study Arms (2)

platelet rich plasma injection

EXPERIMENTAL

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

Other: platelet rich plasma

5% dextrose

PLACEBO COMPARATOR

5% dextrose for hydrodissection

Other: 5% dextrose

Interventions

platelet rich plasmaOTHER

Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.

platelet rich plasma injection
5% dextroseOTHER

Ultrasound-guided 3cc 5% dextrose injection between proximal carpal tunnel and median nerve.

5% dextrose

Eligibility Criteria

Age20 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • Cancer
  • Coagulopathy
  • Pregnancy
  • Inflammation status
  • Cervical radiculopathy
  • Polyneuropathy, brachial plexopathy
  • Thoracic outlet syndrome
  • Previously undergone wrist surgery or steroid injection for CTS

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Taipei, Neihu District, 886, Taiwan

Location

Related Publications (5)

  • 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.

    PMID: 25230270RESULT

  • 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.

    PMID: 23723151RESULT

  • 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.

    PMID: 23640879RESULT

  • 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.

    PMID: 23558771RESULT

  • 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.

    PMID: 24168291RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Glucose

Condition Hierarchy (Ancestors)

Median NeuropathyMononeuropathiesPeripheral Nervous System DiseasesNeuromuscular DiseasesNervous System DiseasesNerve Compression SyndromesCumulative Trauma DisordersSprains and StrainsWounds and Injuries

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydrates

Study Officials

  • Yung-Tsan Wu, MD.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Attending Physician of Department of Physical Medicine and Rehabilitation

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 2, 2016

Study Start

February 1, 2016

Primary Completion

July 31, 2017

Study Completion

July 31, 2017

Last Updated

June 19, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will share

Locations

TW(1)