The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Effect of Sono-guided Injection With Platelet Rich Plasma for Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02539186
• Other study ID #: TSGHIRB No: 1-104-05-108
• Status: Completed
• Phase: N/A
• First received: August 31, 2015
• Last updated: October 10, 2017
• Start date: August 2015
• Est. completion date: September 2017

Study information

• Verified date: October 2017
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

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

Device:
• splint

Locations

Country	Name	City	State
Taiwan	Tri-Service General Hospital	Taipei	Neihu

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

Küçük L, Günay H, Erbas O, Küçük Ü, 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. — View Citation

Lichtenfels M, Colomé 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Secondary	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.	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Secondary	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).	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.
Secondary	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	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.