Platelet Rich Plasma and Hydrodissection for Carpal Tunnel Syndrome

NCT02986828 | Completed DMC

• 1 other identifier: PRP and hydrodissection
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Carpal Tunnel Syndrome

Keywords

platelet rich plasma; Hydrodissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Change from baseline of severity of symptoms and functional status on 2nd week, 1st, 3rd, 6th month and 1 year after injection

  Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection

• Change from baseline of cross-sectional area of the median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection

  Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection

• Change from baseline of conduction velocity, amplitude of median nerve on 2nd week, 1st, 3rd, 6th month and 1 year after injection

  Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection

• Change from finger pinch on 2nd week, 1st, 3rd, 6th month and 1 year after injection

  Pre-treatment, 2nd week, 1st, 3rd, 6th month and 1 year after injection

Study Arms (2)

platelet rich plasma injection

EXPERIMENTAL

The platelet rich plasma (PRP) is a new and potential treatment for peripheral neuropathy in many animal studies.

Drug: platelet rich plasma; Device: Ultrasound

Normal saline

ACTIVE COMPARATOR

Normal saline for ultrasound-guided hydrodissection

Drug: Normal saline; Device: Ultrasound

Interventions

platelet rich plasma DRUG

Ultrasound-guided 3cc PRP injection between proximal carpal tunnel and median nerve.

platelet rich plasma injection

Normal saline DRUG

Ultrasound-guided 3cc normal saline injection between proximal carpal tunnel and median nerve.

Normal saline

Ultrasound DEVICE

Normal saline; platelet rich plasma injection

Eligibility Criteria

• Age: 20 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age between 20-80 year-old.
• Diagnosis was confirmed using an electrophysiological study

You may not qualify if:

• Cancer
• Coagulopathy
• Pregnancy
• Inflammation status
• Cervical radiculopathy
• Polyneuropathy, brachial plexopathy
• Thoracic outlet syndrome
• Previously undergone wrist surgery or steroid injection for CTS

Sponsors & Collaborators

• Tri-Service General Hospital: lead

Study Sites (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

Location

Related 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.12162. Epub 2013 Oct 29.

  PMID: 24168291 RESULT

• Sanchez 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;22(5):1084-9. doi: 10.1007/s00167-013-2479-y. Epub 2013 Mar 22.

  PMID: 23519544 RESULT

• 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.

  PMID: 24425846 RESULT

• 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.

  PMID: 26807124 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Saline Solution; Ultrasonography

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)

Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Yung-Tsan Wu, MD

  Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Physician of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: December 6, 2016
• First Posted: December 8, 2016
• Study Start: December 1, 2016
• Primary Completion: October 30, 2019
• Study Completion: October 30, 2019
• Last Updated: October 31, 2019

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will share

Locations

TW (1)