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

Phase 2

Completed

• Conditions: Tennis Elbow
• Interventions: Procedure: Micocurrent treatment (controlled voltage); Procedure: Microcurrent treatment (controlled current)

• Registration Number: NCT00905736
• 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 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-05-20
• Study First Submitted QC: 2009-05-20
• Study First Posted: 2009-05-21
• 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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
voltage controlled	Micocurrent treatment (controlled voltage)	constant voltage amplitude delivering high frequency AC waveform
current controlled	Microcurrent treatment (controlled current)	a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps

Primary Outcome Measures

Name	Time	Method
Tissue healing as indicated by sonography	baseline, 3 weeks, 6 weeks, 4 months

Secondary Outcome Measures

Name	Time	Method
Patient rated tennis elbow questionnaire	baseline, 3 weeks, 6 weeks, 4 months
Pain free grip strength	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

Trial Locations

Locations (1)

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