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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02800187
Other study ID # TSGHIRB: 2-105-05-031
Secondary ID
Status Completed
Phase N/A
First received June 10, 2016
Last updated October 10, 2017
Start date April 2016
Est. completion date October 2017

Study information

Verified date October 2017
Source Tri-Service General Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The shock wave is a new and potential intervention for the reinnervation of peripheral nerve. The purpose of this study was to assess the dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.


Description:

The investigator perform a prospective randomized, single-blinded study to investigate the dose effect of ESWT in patients with carpal tunnel syndrome.

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 69
Est. completion date October 2017
Est. primary completion date October 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ESWT
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)

Seok H, Kim SH. The effectiveness of extracorporeal shock wave therapy vs. local steroid injection for management of carpal tunnel syndrome: a randomized controlled trial. Am J Phys Med Rehabil. 2013 Apr;92(4):327-34. doi: 10.1097/PHM.0b013e31826edc7b. — 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 pain on 4th, 8th, 12th, 16th and 24th weeks after treatment. Visual analog scale (VAS) Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment
Secondary Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks Using the Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment. 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
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