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Effectiveness of Microcurrent for Treatment of Tennis Elbow

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Microcurrent (Elexoma Medic)
Sponsored by
University of Hertfordshire
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring tennis elbow, microcurrent, tissue healing

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Hertfordshire

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Treatment 1

Treatment 2

Arm Description

50 microamp amplitude

500 microamp amplitude

Outcomes

Primary Outcome Measures

Tendon pathology as indicated by sonography
Patient-Rated Global Change Score

Secondary Outcome Measures

Pain Free Grip Strength
Patient-rated Tennis Elbow Questionnaire
Patient-Specific Functional Scale
Adverse events

Full Information

First Posted
January 5, 2009
Last Updated
June 18, 2010
Sponsor
University of Hertfordshire
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1. Study Identification

Unique Protocol Identification Number
NCT00817232
Brief Title
Effectiveness of Microcurrent for Treatment of Tennis Elbow
Official Title
Effectiveness of Microcurrent in the Treatment of Chronic Tennis Elbow - a Preliminary Trial
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Completed
Study Start Date
December 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University of Hertfordshire

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
tennis elbow, microcurrent, tissue healing

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
24 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment 1
Arm Type
Experimental
Arm Description
50 microamp amplitude
Arm Title
Treatment 2
Arm Type
Experimental
Arm Description
500 microamp amplitude
Intervention Type
Device
Intervention Name(s)
Microcurrent (Elexoma Medic)
Other Intervention Name(s)
Elexoma Medic
Intervention Description
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
Primary Outcome Measure Information:
Title
Tendon pathology as indicated by sonography
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Patient-Rated Global Change Score
Time Frame
3 weeks, 6 weeks, 4 months
Secondary Outcome Measure Information:
Title
Pain Free Grip Strength
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Patient-rated Tennis Elbow Questionnaire
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Patient-Specific Functional Scale
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Title
Adverse events
Time Frame
3 weeks, 6 weeks, 4 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
University of Hertfordshire
City
Hatfield
State/Province
Hertfordshire
ZIP/Postal Code
AL10 9AB
Country
United Kingdom

12. IPD Sharing Statement

Links:
URL
http://www.electrotherapy.org
Description
application of electrotherapy

Learn more about this trial

Effectiveness of Microcurrent for Treatment of Tennis Elbow

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