The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal Tunnel Syndrome

Carpal Tunnel Syndrome Clinical Trial

Official title:

The Effect of Extracorporeal Shock Wave Therapy in Patients With Mild to Moderate Carpal Tunnel Syndrome

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02800187
• Other study ID #: TSGHIRB: 2-105-05-031
• 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
• 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.

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome
• Syndrome

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