Clinical trial NCT02539186: 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
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2015-09-02
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
timeFrame: 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Secondary outcomes:
measure: Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
measure: Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
measure: Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
measure: Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Tri-Service General Hospital
state: Neihu
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.
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.