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

Study Overview
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Brief Summary
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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.

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

Conditions
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Tennis Elbow

Intervention / Treatment
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* Procedure: Microcurrent treatment (controlled current)
* Procedure: Micocurrent treatment (controlled voltage)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: current controlled<br>a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps | Procedure: Microcurrent treatment (controlled current)<br>* primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks<br>|
| Experimental: voltage controlled<br>constant voltage amplitude delivering high frequency AC waveform | Procedure: Micocurrent treatment (controlled voltage)<br>* Microcurrent delivered for 6 hours daily for 3 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue healing as indicated by sonography |  | baseline, 3 weeks, 6 weeks, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient rating global change |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Pain free grip strength |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Patient rated tennis elbow questionnaire |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Adverse events |  | 3 weeks, 6 weeks, 4 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tendon, healing, microcurrent, chronic tennis elbow