The Effect of ESWT for Cubital Tunnel Syndrome

Cubital Tunnel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02801461
• Other study ID #: TSGHIRB: 2-105-05-032
• Status: Completed
• Phase: N/A
• First received: June 10, 2016
• Last updated: April 23, 2018
• Start date: October 2016
• Est. completion date: December 31, 2017

Study information

• Verified date: April 2018
• 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 effect of extracorporeal shock wave therapy on cubital tunnel syndrome.

Description:

Investigators perform a prospective randomized, single-blinded study to investigate the effect of ESWT in patients with cubital tunnel syndrome.

Patients were randomized into intervention and control group. Participants in intervention group received three-sessions of ESWT and single one session of ESWT was given in control group. 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: 7
• Est. completion date: December 31, 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 80 Years

Eligibility

Inclusion Criteria:

1. Age between 20-80 year-old.

2. Typical symptoms and signs of cubital tunnel, such as positive Tinel's sign numbness/tingling in at least 5th 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 cubital tunnel syndrome, such as cervical radiculopathy, polyneuropathy, brachial plexopathy, thoracic outlet syndrome or who had previously undergone wrist surgery or steroid injection for cubital tunnel syndrome.

Related Conditions & MeSH terms

• Cubital Tunnel Syndrome
• Syndrome

Intervention

Device:
• extracorporeal shock wave therapy
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)

Assmus H, Antoniadis G, Bischoff C, Hoffmann R, Martini AK, Preissler P, Scheglmann K, Schwerdtfeger K, Wessels KD, Wüstner-Hofmann M. Cubital tunnel syndrome - a review and management guidelines. Cent Eur Neurosurg. 2011 May;72(2):90-8. doi: 10.1055/s-0031-1271800. Epub 2011 May 4. Review. — 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. Epub 2015 Dec 10. — 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 Disabilities of the Arm, Shoulder and Hand 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 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