The Dose Effect of Extracorporeal Shock Wave Therapy in Patients With Carpal 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 dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Detailed Description
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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.

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

Conditions
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Carpal Tunnel Syndrome

Intervention / Treatment
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* Device: ESWT


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 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: Cancer Coagulopathy Pregnancy Inflammation status 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 85 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>Active three-sessions of ESWT ( once a week for 3 weeks) was given. | Device: ESWT<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>One-session of ESWTactive ESWT was given. | Device: ESWT<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: Night splint<br>The night splint was firmly fixed in a neutral position to immobilize the affected wrist. Patients were ordered to wear the splint while resting at night and at least 8 hours per day during the period of study. Another 3 sessions of sham ESWT was given. | Device: ESWT<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 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 | 
| 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 | 
| 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 |