Effectiveness of Microcurrent for Treatment of Tennis Elbow

NCT ID: NCT00817232

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

2008-12-31

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 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

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Conditions

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Tennis Elbow

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment 1

50 microamp amplitude

Group Type EXPERIMENTAL

Microcurrent (Elexoma Medic)

Intervention Type DEVICE

monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days

Treatment 2

500 microamp amplitude

Group Type EXPERIMENTAL

Microcurrent (Elexoma Medic)

Intervention Type DEVICE

monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days

Interventions

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Microcurrent (Elexoma Medic)

monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days

Intervention Type DEVICE

Other Intervention Names

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Elexoma Medic

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
* other pathology affecting distal upper limb
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/10/08/05

Identifier Type: -

Identifier Source: org_study_id

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