Platelet Rich Plasma for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Long-term Effect of Platelet-rich Plasma in Patients With Carpal Tunnel Syndrome: a Prospective Randomized Double-blind Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03184688
• Other study ID #: Perineural PRP for CTS
• Status: Completed
• Phase: N/A
• Start date: September 8, 2017
• Est. completion date: October 30, 2019

Study information

• Verified date: October 2019
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Carpal tunnel syndrome (CTS) is the most common peripheral entrapment neuropathy with involving compression of the median nerve in the carpal tunnel. 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, four small clinical trials showed the positive effect of PRP in peripheral neuropathy. Among these studies, two small trials showed beneficial effect of PRP for patients with mild CTS. However, the definite clinical effect of PRP for peripheral neuropathy from currently published studies is unclarified because these studies enrolled a few patients and lacked long-term follow-up (no more than 6 months follow-up).

Description:

After obtaining written informed consent, patients of clinically diagnosed with bilateral CTS were randomized into intervention and control side. Intervention group received one-dose ultrasound-guided PRP injection and control group 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 30, 2019
• Est. primary completion date: October 30, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

• Age between 20-80 year-old.

• Diagnosis was confirmed using an electrophysiological study

Exclusion Criteria:

• Cancer

• Coagulopathy

• Pregnancy

• Inflammation status

• Polyneuropathy, brachial plexopathy

• Thoracic outlet syndrome

• Previously undergone wrist surgery or steroid injection for CTS

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• platelet rich plasma
Ultrasound-guided PRP injection between proximal carpal tunnel and median nerve.

Drug:
• Normal saline
Ultrasound-guided normal saline injection between proximal carpal tunnel and median nerve.

Locations

Country	Name	City	State
Taiwan	Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital	Taipei	Neihu District

Sponsors (1)

Lead Sponsor	Collaborator
Tri-Service General Hospital

Country where clinical trial is conducted

Taiwan, 

References & Publications (4)

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. — View Citation

Mulvaney SW. Ultrasound-guided percutaneous neuroplasty of the lateral femoral cutaneous nerve for the treatment of meralgia paresthetica: a case report and description of a new ultrasound-guided technique. Curr Sports Med Rep. 2011 Mar-Apr;10(2):99-104. — View Citation

Uzun H, Bitik O, Uzun Ö, Ersoy US, Aktas E. Platelet-rich plasma versus corticosteroid injections for carpal tunnel syndrome. J Plast Surg Hand Surg. 2017 Oct;51(5):301-305. doi: 10.1080/2000656X.2016.1260025. Epub 2016 Dec 6. — View Citation

Wu YT, Ho TY, Chou YC, Ke MJ, Li TY, Huang GS, Chen LC. Six-month efficacy of platelet-rich plasma for carpal tunnel syndrome: A prospective randomized, single-blind controlled trial. Sci Rep. 2017 Dec;7(1):94. doi: 10.1038/s41598-017-00224-6. Epub 2017 M — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and one year after the treatment.	Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of carpal tunnel syndrome which encompasses symptom severity and functional status. Each question ranges from 1 to 5 with a higher score indicating severer symptom or a higher degree of disability. Total score ranges from 19 to 95 and the mean of total scores divided with each item score were used for further analysis.	Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.
Secondary	Change from baseline in severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and one year after the treatment.	Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.	Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.
Secondary	Change from baseline in cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment.	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.	Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.
Secondary	Change from baseline in conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and one year after the treatment.	The antidromic sensory nerve conduction velocity of the median nerve was performed on all subjects according to the protocol reported by the American Academy of Neurology (USA). The median nerve was stimulated at the wrist between the palmar longus and flexor carpal radialis tendon at a distance of approximately 14 cm from the active electrode.	Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.
Secondary	Change from baseline in finger pinch on 2nd week, 1st, 3rd, 6th month and one year after the treatment.	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	Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.