Clinical trial NCT02800200: The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome
Official title: The Long-term Effect of Combined Platelet Rich Plasma With Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: platelet rich plasma
extracorporeal shock wave
Lead sponsor: Tri-Service General Hospital
Sponsor class: OTHER
First posted: 2016-06-15
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary outcomes:
measure: Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment.
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
measure: Change from baseline of cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
measure: Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks
timeFrame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital
state: Neihu District
Study officials:
affiliation: Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital, School of Medicine, National Defense Medical Center
name: Yung-Tsan Wu, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
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. Epub 2015 Dec 10.