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Completed

NCT Number: NCT02801461

The Effect of ESWT for Cubital Tunnel Syndrome

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.

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Key information

Conditions

Cubital Tunnel Syndrome Cumulative Trauma Disorders Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Ulnar Nerve Compression Syndromes Ulnar Neuropathies Wounds and Injuries

Age range

20 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Department of Physical Medicine and Rehabilitation, Tri-Service General Hospital

Taipei, Neihu District, 886, Taiwan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Extracorporeal Shock Wave Therapy

Device

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).

Primary outcomes

  1. Change from baseline of pain on 4th, 8th, 12th, 16th and 24th weeks after treatment

    Time frame: Pre-treatment, 4th, 8th, 12th, 16th and 24th weeks after treatment

    Visual analog scale (VAS)

Secondary outcomes

  1. Change from baseline of severity of symptoms and functional status on 4th, 8th, 12th, 16th and 24th weeks

    Time frame: 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.

  2. Change from baseline of electrophysiological study on 4th, 8th, 12th, 16th and 24th weeks

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Tri-Service General Hospital (TSGH)

Other

Registry information

Official study title

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

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Jun 15, 2016
Registry last updated
Apr 25, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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