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OpenTrials
Completed

NCT Number: NCT00817232

Effectiveness of Microcurrent for Treatment of Tennis Elbow

Tennis elbow is a relatively common musculoskeletal disorder that can cause significant pain and disability. Treatment of the disorder is not always successful, and it often recurs or becomes chronic. More effective management options are required. There is evidence that electric microcurrent can promote tissue healing and symptom resolution in various chronic hard and soft tissue disorders, but few human studies investigating its use with chronic tendon problems. It is an easily applied therapy with very few reports of side effects. It can be applied at home using a portable unit and, if it is clinically effective, may also prove more cost effective than other therapies.

A clinical trial is planned to evaluate the therapy but, in the absence of relevant published evidence, a preliminary study is required to look for a treatment effect and inform a power calculation for sample size, The study will also allow some investigation of dose-dependence, which is a key issue in many forms of electrotherapy. Finally it will enable evaluation of elements of the full trial protocol so that any weaknesses can be addressed before it begins.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

University of Hertfordshire

Hatfield, Hertfordshire, AL10 9AB, United Kingdom

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • symptoms of tennis elbow for at least 3 months
  • clinical diagnosis of tennis elbow

Exclusion criteria

  • significant symptom improvement in previous month
  • receipt of any active treatment for the condition in the previous month
  • currently under the care of another health professional for tennis elbow
  • current cervical radiculopathy
  • other pathology affecting distal upper limb

Treatment and study plan

Microcurrent (Elexoma Medic)

Device

monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days

Other names: Elexoma Medic

Primary outcomes

  1. Tendon pathology as indicated by sonography

    Time frame: baseline, 3 weeks, 6 weeks, 4 months

  2. Patient-Rated Global Change Score

    Time frame: 3 weeks, 6 weeks, 4 months

Secondary outcomes

  1. Pain Free Grip Strength

    Time frame: baseline, 3 weeks, 6 weeks, 4 months

  2. Patient-rated Tennis Elbow Questionnaire

    Time frame: baseline, 3 weeks, 6 weeks, 4 months

  3. Patient-Specific Functional Scale

    Time frame: baseline, 3 weeks, 6 weeks, 4 months

  4. Adverse events

    Time frame: 3 weeks, 6 weeks, 4 months

Sponsors and collaborators

Lead sponsor

University of Hertfordshire

Other

Registry information

Official study title

Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 6, 2009
Registry last updated
Jun 22, 2010

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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