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Completed

NCT Number: NCT02609113

Static Magnetic Therapy for Carpal Tunnel Syndrome

The purpose of this research study is to investigate if magnet therapy is effective as an alternative therapy for CTS.

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Key information

Conditions

Carpal Tunnel Syndrome Cumulative Trauma Disorders Median Neuropathy Mononeuropathies Nerve Compression Syndromes Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases Sprains and Strains Wounds and Injuries

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wake Forest Baptist Health

Winston-Salem, North Carolina, 27157, United States

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of mild to moderate Carpal Tunnel Syndrome by history, clinical exam and Electromyography (EMG) study.
  • ≥ 18 years

Exclusion criteria

  • Current use of magnets as therapy for Carpal Tunnel Syndrome
  • Known allergy to silicone
  • Unwillingness to wear wristband for 6 weeks
  • Patients who have devices that may be affected by exposure to magnets such as vagal nerve stimulator, pacemaker or insulin pump.

Treatment and study plan

Strong Magnetic Wristband

Device

Weaker Magnetic Wristband

Device

Primary outcomes

  1. Change in Boston Carpal Tunnel Questionnaire (BCTQ) Score at 6 Weeks

    Time frame: Baseline and 6 weeks

    Patient reported outcome measure of symptom severity and functional status. Is made of the Symptom severity scale (11 items) score 1 to 5 where lower numbers denotes better outcomes; and the Functional status scale (8 items) score 1 to 5 where lower numbers denotes better outcomes. Total score 1- 95 where lower numbers denotes better outcomes.

Secondary outcomes

  1. Change in Echogenicity (Hyper or Hypo) on the Median Nerve Ultrasound at 6 Weeks

    Time frame: Baseline and 6 weeks

    Ultrasound to assess the anatomy of the median nerve

  2. Change in Cross-sectional Area as Measured in mm2 on Median Nerve Ultrasound at 6 Weeks

    Time frame: Baseline and 6 weeks

    Ultrasound to assess the anatomy of the median nerve

  3. Change in Vascularity (Normal or Abnormal) as Measured on Median Nerve Ultrasound at 6 Weeks

    Time frame: Baseline and 6 weeks

    Ultrasound to assess the anatomy of the median nerve

Sponsors and collaborators

Lead sponsor

Wake Forest University Health Sciences

Other

Registry information

Official study title

A Double Blinded, Prospective, Randomized Trial of Static Magnetic Therapy for Carpal Tunnel Syndrome (CTS)

Acronym: ATTRACT

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Nov 20, 2015
Registry last updated
Sep 10, 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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