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Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00905736
Recruitment Status : Completed
First Posted : May 21, 2009
Last Update Posted : June 22, 2010
Information provided by:
University of Hertfordshire

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Tennis Elbow Procedure: Microcurrent treatment (controlled current) Procedure: Micocurrent treatment (controlled voltage) Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial
Study Start Date : April 2009
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: current controlled
a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
Procedure: Microcurrent treatment (controlled current)
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks

Experimental: voltage controlled
constant voltage amplitude delivering high frequency AC waveform
Procedure: Micocurrent treatment (controlled voltage)
Microcurrent delivered for 6 hours daily for 3 weeks

Primary Outcome Measures :
  1. Tissue healing as indicated by sonography [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ]

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00905736

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United Kingdom
University of Hertfordshire
Hatfield, Hertfordshire, United Kingdom, AL10 9AB
Sponsors and Collaborators
University of Hertfordshire
Additional Information:
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Responsible Party: Leon Poltawski, University of Hertfordshire Identifier: NCT00905736    
Other Study ID Numbers: HEPEC/03/09/74
First Posted: May 21, 2009    Key Record Dates
Last Update Posted: June 22, 2010
Last Verified: August 2009
Keywords provided by University of Hertfordshire:
chronic tennis elbow
Additional relevant MeSH terms:
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Tennis Elbow
Elbow Tendinopathy
Muscular Diseases
Musculoskeletal Diseases
Arm Injuries
Wounds and Injuries
Tendon Injuries