The Effect of ESWT for Cubital Tunnel Syndrome

Not Applicable

Completed

• Conditions: Cubital Tunnel Syndrome
• Interventions: Device: extracorporeal shock wave therapy

• Registration Number: NCT02801461
• Lead Sponsor: Tri-Service General Hospital

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-14
• Study First Posted: 2016-06-15
• Study Start: 2016-10
• Primary Completion: 2017-12
• Study Completion: 2017-12-31
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-23
• Last Update Posted: 2018-04-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 7

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Three-sessions of ESWT	extracorporeal shock wave therapy	ESWT was given once a week for 3 weeks.
One-session of ESWT	extracorporeal shock wave therapy	Single ESWT was given.

Primary Outcome Measures

Name	Time	Method
Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	Visual analog scale (VAS)

Secondary Outcome Measures

Name	Time	Method
Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	Using the Disabilities of the Arm, Shoulder and Hand to measure the symptoms and functional status before treatment and multiple time frame after treatment.
Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	electrophysiological study according to the protocol reported by the American Academy of Neurology with SierraWave, Cadwell (USA

Trial Locations

Locations (1)

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital; 🇨🇳 Taipei, Neihu District, Taiwan