The Effect of Combined PRP and ESWT for Carpal Tunnel Syndrome

Tri-Service General Hospital

Status: Completed

Conditions: Carpal Tunnel Syndrome

Treatments: Device: shock wave; Procedure: Platelet rich plasma

Study type: Interventional

Funder types: Other

Identifiers

NCT02800200

TSGHIRB No: 2-105-05-026

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 20 to 85 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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40 participants in 3 patient groups, including a placebo group

Platelet rich plasma

Experimental group

Description:

The ultrasoud-guided injection with Platelet rich plasma (3cc) was perfomed in both groups.

Treatment:

Procedure: Platelet rich plasma

Device: shock wave

Active shock wave

Experimental group

Description:

One-session active shock wave 2 weeks later after PRP injection was performed in intervention group.

Treatment:

Procedure: Platelet rich plasma

Device: shock wave

Sham shock wave

Placebo Comparator group

Description:

One-session sham shock wave 2 weeks later after PRP injection was performed in control group.

Treatment:

Procedure: Platelet rich plasma

Device: shock wave