Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Long-term Effect of Platelet Rich Plasma and Hydrodissection for Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02986828
• Other study ID #: PRP and hydrodissection
• Status: Completed
• Phase: N/A
• Start date: December 1, 2016
• 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. 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, three small clinical trials showed the positive effect of PRP in peripheral neuropathy included CTSin a pilot research. 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. The investigators design a randomized, double-blind, controlled trail to assess the effect after ultrasound-guided PRP injection in patients with CTS.

Description:

After obtaining written informed consent, patients with bilateral CTS will been randomized into intervention and control side. Participants in intervention group received one-dose ultrasound-guided PRP injection and control side 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

• Cervical radiculopathy

• Polyneuropathy, brachial plexopathy

• Thoracic outlet syndrome

• Previously undergone wrist surgery or steroid injection for CTS

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Drug:
• platelet rich plasma
Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.
• Normal saline
Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.

Device:
• Ultrasound

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)

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.1 — View Citation

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

Sánchez M, Yoshioka T, Ortega M, Delgado D, Anitua E. Ultrasound-guided platelet-rich plasma injections for the treatment of common peroneal nerve palsy associated with multiple ligament injuries of the knee. Knee Surg Sports Traumatol Arthrosc. 2014 May; — View Citation

Scala M, Mereu P, Spagnolo F, Massa M, Barla A, Mosci S, Forno G, Ingenito A, Strada P. The use of platelet-rich plasma gel in patients with mixed tumour undergoing superficial parotidectomy: a randomized study. In Vivo. 2014 Jan-Feb;28(1):121-4. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of pain on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Using the Visual analog scale (VAS) to measure the pain scale before treatment and multiple time frame after treatment.	Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Secondary	Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the severity of symptoms and functional status before treatment and multiple time frame after treatment.	Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Secondary	Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve before treatment and multiple time frame after treatment.	Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Secondary	Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection	antidromic sensory nerve conduction velocity of the median nerve before treatment and multiple time frame after treatment.	Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection
Secondary	Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection	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	Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection