Effectiveness of Microcurrent for Treatment of Tennis Elbow

Phase 2

Completed

• Conditions: Tennis Elbow
• Interventions: Device: Microcurrent (Elexoma Medic)

• Registration Number: NCT00817232
• Lead Sponsor: 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-12
• Study First Submitted: 2009-01-05
• Study First Submitted QC: 2009-01-05
• Study First Posted: 2009-01-06
• Status Verified: 2009-08
• Primary Completion: 2009-12
• Study Completion: 2009-12
• Last Update Submitted: 2010-06-18
• Last Update Posted: 2010-06-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 24

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Treatment 2	Microcurrent (Elexoma Medic)	500 microamp amplitude
Treatment 1	Microcurrent (Elexoma Medic)	50 microamp amplitude

Primary Outcome Measures

Name	Time	Method
Patient-Rated Global Change Score	3 weeks, 6 weeks, 4 months
Tendon pathology as indicated by sonography	baseline, 3 weeks, 6 weeks, 4 months

Secondary Outcome Measures

Name	Time	Method
Pain Free Grip Strength	baseline, 3 weeks, 6 weeks, 4 months
Adverse events	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

Trial Locations

Locations (1)

University of Hertfordshire; 🇬🇧 Hatfield, Hertfordshire, United Kingdom