The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800200
• Other study ID #: TSGHIRB No: 2-105-05-026
• Status: Completed
• Phase: N/A
• Start date: June 16, 2016
• Est. completion date: September 15, 2017

Study information

• Verified date: July 2018
• Source: Tri-Service General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 15, 2017
• Est. primary completion date: September 15, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 85 Years

Eligibility

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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

Intervention

Procedure:
• Platelet rich plasma
Sono-guided injection with 3 cc Platelet rich plasma were performed in both groups.

Device:
• shock wave
Shock waves are defined a sequence of acoustic pulse characterized by a high peak pressure (100 MPa), fast pressure rise (< 10 ns) and short duration (10 µs).

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 (2)

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

Wu YT, Ke MJ, Chou YC, Chang CY, Lin CY, Li TY, Shih FM, Chen LC. Effect of radial shock wave therapy for carpal tunnel syndrome: A prospective randomized, double-blind, placebo-controlled trial. J Orthop Res. 2016 Jun;34(6):977-84. doi: 10.1002/jor.23113 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks	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.	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary	Change from baseline of pain on 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.	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary	Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary	Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks	electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA).	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment