Platelet Rich Plasma for Carpal Tunnel Syndrome

NCT03184688 | Completed DMC

• 1 other identifier: Perineural PRP for CTS
• 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. 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).

Conditions

Carpal Tunnel Syndrome

Keywords

platelet rich plasma; Perineural injection therapy; hydrodissection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

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

  Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.

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

  Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.

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

  Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.

• Change from baseline in finger pinch on 2nd week, 1st, 3rd, 6th month and one year after the treatment.

  Baseline, 2nd week, 1st, 3rd, 6th month and one year after treatment.

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.

Procedure: platelet rich plasma

Normal saline

PLACEBO COMPARATOR

Normal saline for hydrodissection

Drug: Normal saline

Interventions

platelet rich plasma PROCEDURE

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

platelet rich plasma injection

Normal saline DRUG

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

Normal saline

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
• 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)

• 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 Mar 7.

  PMID: 28273894 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

• Uzun H, Bitik O, Uzun O, 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.

  PMID: 27921443 RESULT

• 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. doi: 10.1249/JSR.0b013e3182110096.

  PMID: 21623291 RESULT

MeSH Terms

Conditions

Carpal Tunnel Syndrome

Interventions

Saline Solution

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

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: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• 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: June 7, 2017
• First Posted: June 14, 2017
• Study Start: September 8, 2017
• 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 not share

Locations

TW (1)