The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

NCT02539186 | Completed DMC

• 1 other identifier: TSGHIRB No: 1-104-05-108
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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.

Conditions

Carpal Tunnel Syndrome

Outcome Measures

Primary Outcomes (1)

• Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

  Visual analog scale (VAS)

  1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

Secondary Outcomes (4)

• Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

• Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

• Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

• Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks

  Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.

Study Arms (2)

platelet rich plasma

EXPERIMENTAL

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

Biological: platelet rich plasma

splinting

ACTIVE COMPARATOR

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.

Device: splint

Interventions

platelet rich plasma BIOLOGICAL

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

platelet rich plasma

splint DEVICE

splinting

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Tri-Service General Hospital

Taipei, Neihu, 886, Taiwan

Location

Related Publications (4)

• 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: 25230270 BACKGROUND

• 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: 23723151 BACKGROUND

• 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: 23640879 BACKGROUND

• 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: 23558771 BACKGROUND

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Splints

Condition Hierarchy (Ancestors)

Median Neuropathy; Mononeuropathies; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Nerve Compression Syndromes; Cumulative Trauma Disorders; Sprains and Strains; Wounds and Injuries

Intervention Hierarchy (Ancestors)

External Fixators; Orthopedic Fixation Devices; Orthopedic Equipment; Surgical Equipment; Equipment and Supplies; Surgical Fixation Devices

Study Officials

• Yung-Tsan Wu, MD

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending physician

Study Record Dates

• First Submitted: August 31, 2015
• First Posted: September 2, 2015
• Study Start: August 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: October 11, 2017

Record last verified: 2017-10

Locations

TW (1)