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

June 18, 2010 updated by: University of Hertfordshire

Influence of Microcurrent Parameters on Effectiveness of Treatment of Chronic Tennis Elbow - a Preliminary Trial

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

24

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Hertfordshire
      • Hatfield, Hertfordshire, United Kingdom, AL10 9AB
        • University of Hertfordshire

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: current controlled
a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
Procedure: Microcurrent treatment (controlled current)
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
Experimental: voltage controlled
constant voltage amplitude delivering high frequency AC waveform
Procedure: Micocurrent treatment (controlled voltage)
Microcurrent delivered for 6 hours daily for 3 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Tissue healing as indicated by sonography
Time Frame: baseline, 3 weeks, 6 weeks, 4 months
baseline, 3 weeks, 6 weeks, 4 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: 3 weeks, 6 weeks, 4 months
3 weeks, 6 weeks, 4 months
Patient rating global change
Time Frame: baseline, 3 weeks, 6 weeks, 4 months
baseline, 3 weeks, 6 weeks, 4 months
Pain free grip strength
Time Frame: baseline, 3 weeks, 6 weeks, 4 months
baseline, 3 weeks, 6 weeks, 4 months
Patient rated tennis elbow questionnaire
Time Frame: baseline, 3 weeks, 6 weeks, 4 months
baseline, 3 weeks, 6 weeks, 4 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Hertfordshire

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Actual)

December 1, 2009

Study Completion (Actual)

December 1, 2009

Study Registration Dates

First Submitted

May 20, 2009

First Submitted That Met QC Criteria

May 20, 2009

First Posted (Estimate)

May 21, 2009

Study Record Updates

Last Update Posted (Estimate)

June 22, 2010

Last Update Submitted That Met QC Criteria

June 18, 2010

Last Verified

August 1, 2009

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HEPEC/03/09/74

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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