The Effect of Platelet Rich Plasma for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Biological: platelet rich plasma; Device: splint

• Registration Number: NCT02539186
• Lead Sponsor: Tri-Service General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-31
• Study First Submitted QC: 2015-09-01
• Study First Posted: 2015-09-02
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
platelet rich plasma	platelet rich plasma	Sono-guided injection with 3cc platelet rich plasma between carpal tunnel and median nerve in intervention group.
splinting	splint	The wrist night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study in control group.

Primary Outcome Measures

Name	Time	Method
Change from baseline of pain on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.	1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.	Visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Change from baseline of severity of symptoms and functional status 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.	Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline of cross-sectional area in median nerve on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
Change from baseline of electrophysiological study on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.	electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).
Change from baseline in finger pinch on 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 1st, 2nd, 4th, 8th, 12th, 16th and 24th weeks after treatment.	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

Trial Locations

Locations (1)

Tri-Service General Hospital; 🇨🇳 Taipei, Neihu, Taiwan