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

Not Applicable

Completed

• Conditions: Carpal Tunnel Syndrome
• Interventions: Device: ESWT

• Registration Number: NCT02800187
• 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 dose effect of extracorporeal shock wave therapy on carpal tunnel syndrome.

Detailed 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.

Study Timeline

• Study Start: 2016-04
• Study First Submitted: 2016-06-10
• Study First Submitted QC: 2016-06-10
• Study First Posted: 2016-06-15
• Status Verified: 2017-10
• Primary Completion: 2017-10
• Study Completion: 2017-10
• Last Update Submitted: 2017-10-10
• Last Update Posted: 2017-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 69

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
three-sessions of ESWT	ESWT	Active three-sessions of ESWT ( once a week for 3 weeks) was given.
one-session of ESWT	ESWT	One-session of ESWTactive ESWT was given.
Night splint	ESWT	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.

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 cross-sectional area in median nerve on 4th, 8th, 12th, 16th and 24th weeks	Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment	Using the musculoskeletal sonogram to measure the cross-sectional area of the median nerve.
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).
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 Boston Carpal Tunnel Syndrome Questionnaire to measure the symptoms and functional status before treatment and multiple time frame after treatment.

Trial Locations

Locations (1)

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