Effectiveness of Microcurrent for Treatment of Tennis Elbow
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Tennis Elbow |
Device: Microcurrent (Elexoma Medic) |
Phase 2 Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial |
- Tendon pathology as indicated by sonography [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
- Patient-Rated Global Change Score [ Time Frame: 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
- Pain Free Grip Strength [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
- Patient-rated Tennis Elbow Questionnaire [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
- Patient-Specific Functional Scale [ Time Frame: baseline, 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: No ]
- Adverse events [ Time Frame: 3 weeks, 6 weeks, 4 months ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 24 |
| Study Start Date: | December 2008 |
| Study Completion Date: | December 2009 |
| Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Treatment 1
50 microamp amplitude
|
Device: Microcurrent (Elexoma Medic)
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
Other Name: Elexoma Medic
|
|
Experimental: Treatment 2
500 microamp amplitude
|
Device: Microcurrent (Elexoma Medic)
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
Other Name: Elexoma Medic
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
- other pathology affecting distal upper limb
Contacts and Locations
More Information
Additional Information:
No publications provided
| Responsible Party: | Leon Poltawski, University of Hertfordshire |
| ClinicalTrials.gov Identifier: | NCT00817232 History of Changes |
| Other Study ID Numbers: | HEPEC/10/08/05 |
| Study First Received: | January 5, 2009 |
| Last Updated: | June 18, 2010 |
| Health Authority: | United Kingdom: Research Ethics Committee |
Keywords provided by University of Hertfordshire:
|
tennis elbow microcurrent tissue healing |
Additional relevant MeSH terms:
|
Tennis Elbow Musculoskeletal Diseases Arm Injuries Wounds and Injuries |
ClinicalTrials.gov processed this record on May 23, 2013