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

NCT ID: NCT00905736

Last Updated: 2010-06-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2009-12-31

Brief Summary

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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

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Conditions

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Tennis Elbow

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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current controlled

a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps

Group Type EXPERIMENTAL

Microcurrent treatment (controlled current)

Intervention Type PROCEDURE

primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks

voltage controlled

constant voltage amplitude delivering high frequency AC waveform

Group Type EXPERIMENTAL

Micocurrent treatment (controlled voltage)

Intervention Type PROCEDURE

Microcurrent delivered for 6 hours daily for 3 weeks

Interventions

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Microcurrent treatment (controlled current)

primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks

Intervention Type PROCEDURE

Micocurrent treatment (controlled voltage)

Microcurrent delivered for 6 hours daily for 3 weeks

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Hertfordshire

OTHER

Sponsor Role lead

Responsible Party

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University of Hertfordshire

Locations

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University of Hertfordshire

Hatfield, Hertfordshire, United Kingdom

Site Status

Countries

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United Kingdom

Related Links

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http://www.electrotherapy.org

application of electrotherapy

Other Identifiers

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HEPEC/03/09/74

Identifier Type: -

Identifier Source: org_study_id

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