Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial
Trial Snapshot
- Phase
- Phase 2
- Status
- Completed
- Sponsor
- Enrollment
- 24
- Locations
- 2
- Primary Endpoint
- Tissue healing as indicated by sonography
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 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.
Study Design
- Study Type
- Interventional
- Allocation
- Non Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- 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
Outcomes
Primary Outcomes
Tissue healing as indicated by sonography
Time Frame: baseline, 3 weeks, 6 weeks, 4 months
Secondary Outcomes
- Pain free grip strength(baseline, 3 weeks, 6 weeks, 4 months)
- Patient rated tennis elbow questionnaire(baseline, 3 weeks, 6 weeks, 4 months)
- Patient rating global change(baseline, 3 weeks, 6 weeks, 4 months)
- Adverse events(3 weeks, 6 weeks, 4 months)