The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Tri-Service General Hospital
- Enrollment
- 40
- Locations
- 2
- Primary Endpoint
- Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 20 Years to 85 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Age between 20-80 year-old.
- •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
- •Coagulopathy
- •Inflammation status
- •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.
Arms & Interventions
Platelet rich plasma
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Intervention: Platelet rich plasma (Procedure)
Platelet rich plasma
The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.
Intervention: shock wave (Device)
Active shock wave
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Intervention: Platelet rich plasma (Procedure)
Active shock wave
One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.
Intervention: shock wave (Device)
Sham shock wave
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Intervention: Platelet rich plasma (Procedure)
Sham shock wave
One-session sham shock wave 2 weeks later after PRP injection was performed in control group.
Intervention: shock wave (Device)
Outcomes
Primary Outcomes
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
Time Frame: 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 Outcomes
- 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)
- 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)
- 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)
Investigators
Yung-Tsan Wu
Attending physician of physical medicine and rehabilitation
Tri-Service General Hospital