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OpenTrials
Completed

NCT Number: NCT00905736

Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic 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 have investigated 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 is comparing the effects of two different forms of microcurrent treatment.

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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

Treatment and study plan

Microcurrent treatment (controlled current)

Procedure

primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks

Micocurrent treatment (controlled voltage)

Procedure

Microcurrent delivered for 6 hours daily for 3 weeks

Primary outcomes

  1. Tissue healing as indicated by sonography

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

Secondary outcomes

  1. Patient rating global change

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

  2. Pain free grip strength

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

  3. Patient rated tennis elbow questionnaire

    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

Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial

Important dates

Study start
2009
Primary completion
2009
Study completion
2009
First posted
May 21, 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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