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
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring tennis elbow, microcurrent, tissue healing
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
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
NCT ID
NCT00817232
First Posted
January 5, 2009
Last Updated
June 18, 2010
Sponsor
University of Hertfordshire
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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