Influence of Microcurrent Parameters on Effectiveness in Treatment of Chronic Tennis Elbow
1 other identifier
interventional
24
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started Apr 2009
Shorter than P25 for phase_2
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 20, 2009
CompletedFirst Posted
Study publicly available on registry
May 21, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2009
CompletedJune 22, 2010
August 1, 2009
8 months
May 20, 2009
June 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Tissue healing as indicated by sonography
baseline, 3 weeks, 6 weeks, 4 months
Secondary Outcomes (4)
Patient rating global change
baseline, 3 weeks, 6 weeks, 4 months
Pain free grip strength
baseline, 3 weeks, 6 weeks, 4 months
Patient rated tennis elbow questionnaire
baseline, 3 weeks, 6 weeks, 4 months
Adverse events
3 weeks, 6 weeks, 4 months
Study Arms (2)
current controlled
EXPERIMENTALa current controlled microcurent device providing a primarily monophasic waveform of typical amplitude 40 microamps
voltage controlled
EXPERIMENTALconstant voltage amplitude delivering high frequency AC waveform
Interventions
primarily monophasic waveform of average amplitude 40 microamps, 1 hr daily for 3 weeks
Microcurrent delivered for 6 hours daily for 3 weeks
Eligibility Criteria
You may qualify if:
- symptoms of tennis elbow for at least 3 months
- clinical diagnosis of tennis elbow
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Hertfordshire
Hatfield, Hertfordshire, AL10 9AB, United Kingdom
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
May 20, 2009
First Posted
May 21, 2009
Study Start
April 1, 2009
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 22, 2010
Record last verified: 2009-08