The Effect of ESWT for Cubital Tunnel Syndrome

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cubital Tunnel Syndrome

Intervention / Treatment
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* Device: extracorporeal shock wave therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age between 20-80 year-old. 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: Cancer Coagulopathy Pregnancy Inflammation status 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Three-sessions of ESWT<br>ESWT was given once a week for 3 weeks. | Device: extracorporeal shock wave therapy<br>* 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).<br>|
| Active Comparator: One-session of ESWT<br>Single ESWT was given. | Device: extracorporeal shock wave therapy<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 |