Effectiveness of Microcurrent for Treatment of Tennis Elbow

Study Overview
=================
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 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.

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

Conditions
-----------------
Tennis Elbow

Intervention / Treatment
-----------------
* Device: Microcurrent (Elexoma Medic)


Participation Criteria
=================
Eligibility Criteria
-----------------
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

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment 1<br>50 microamp amplitude | Device: Microcurrent (Elexoma Medic)<br>* monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days<br>* Other names: Elexoma Medic;|
| Experimental: Treatment 2<br>500 microamp amplitude | Device: Microcurrent (Elexoma Medic)<br>* monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days<br>* Other names: Elexoma Medic;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon pathology as indicated by sonography |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Patient-Rated Global Change Score |  | 3 weeks, 6 weeks, 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Free Grip Strength |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Patient-rated Tennis Elbow Questionnaire |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Patient-Specific Functional Scale |  | baseline, 3 weeks, 6 weeks, 4 months | 
| Adverse events |  | 3 weeks, 6 weeks, 4 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tennis elbow, microcurrent, tissue healing