The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Procedure: Platelet rich plasma; Device: shock wave

• Registration Number: NCT02800200
• Lead Sponsor: Tri-Service General Hospital

Brief Summary

The platelet rich plasma (PRP) and extracorporeal shock wave therapy (ESWT) are new and potential treatment for patients with kinds of musculoskeletal disorders. Although few clinical studies have showed beneficial effect of PRP and ESWT for regeneration of peripheral neuropathy, the effect of combined PRP and ESWT is absent so far.

Detailed Description

We perform a prospective randomized, double-blinded study to investigate the combined effect of PRP and ESWT in patients with carpal tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received sono-guided injection with 3cc PRP and one-session active ESWT and control group received sono-guided injection with 3cc PRP and one-session sham ESWT. The evaluation was performed pretreatment as well as on the 4th, 8th, 12th, 16th and 24 week after the treatment.

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Study Start: 2016-06-16
• Primary Completion: 2017-09-15
• Study Completion: 2017-09-15
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-31
• Last Update Posted: 2018-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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	The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Platelet rich plasma	shock wave	The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Active shock wave	shock wave	One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Sham shock wave	Platelet rich plasma	One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Active shock wave	Platelet rich plasma	One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Sham shock wave	shock wave	One-session sham shock wave 2 weeks later after PRP injection was performed in control group.

Primary Outcome Measures

Name	Time	Method
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	Boston carpal tunnel syndrome questionnaire (BCTQ) is a frequently used patient-based questionnaire for measurement of CTS which encompasses two components. In total, 11 questions and 8 items were evaluated to rate the symptom severity scale (SSS) and functional status scale (FSS), respectively. Both subscales range from 1 to 5 with a higher score indicating a higher degree of disability. The mean of total SSS and FSS divided with each item score were used for further analysis.

Secondary Outcome Measures

Name	Time	Method
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 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 of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	Digital pain severity or paresthesia/dysthesia was evaluated using visual analog scale (VAS). Pain score scale ranged from 0 to 10, with 10 indicating the most severe pain.
Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan