Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
Primary Purpose
Tennis Elbow
Status
Completed
Phase
Phase 2
Locations
United Kingdom
Study Type
Interventional
Intervention
Microcurrent treatment (controlled current)
Micocurrent treatment (controlled voltage)
Sponsored by
About this trial
This is an interventional treatment trial for Tennis Elbow focused on measuring tendon, healing, microcurrent, chronic tennis elbow
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
Sites / Locations
- University of Hertfordshire
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
current controlled
voltage controlled
Arm Description
a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
constant voltage amplitude delivering high frequency AC waveform
Outcomes
Primary Outcome Measures
Tissue healing as indicated by sonography
Secondary Outcome Measures
Patient rating global change
Pain free grip strength
Patient rated tennis elbow questionnaire
Adverse events
Full Information
NCT ID
NCT00905736
First Posted
May 20, 2009
Last Updated
June 18, 2010
Sponsor
University of Hertfordshire
1. Study Identification
Unique Protocol Identification Number
NCT00905736
Brief Title
Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
Official Title
Influence of Microcurrent Parameters on Effectiveness of 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
April 2009 (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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
tendon, healing, microcurrent, chronic tennis elbow
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
24 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
current controlled
Arm Type
Experimental
Arm Description
a current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
Arm Title
voltage controlled
Arm Type
Experimental
Arm Description
constant voltage amplitude delivering high frequency AC waveform
Intervention Type
Procedure
Intervention Name(s)
Microcurrent treatment (controlled current)
Intervention Description
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
Intervention Type
Procedure
Intervention Name(s)
Micocurrent treatment (controlled voltage)
Intervention Description
Microcurrent delivered for 6 hours daily for 3 weeks
Primary Outcome Measure Information:
Title
Tissue healing as indicated by sonography
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
Secondary Outcome Measure Information:
Title
Patient rating global change
Time Frame
baseline, 3 weeks, 6 weeks, 4 months
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
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
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
Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
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