Effectiveness of Microcurrent for Treatment of 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 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.
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 Dec 2008
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
December 1, 2008
CompletedFirst Submitted
Initial submission to the registry
January 5, 2009
CompletedFirst Posted
Study publicly available on registry
January 6, 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
1 year
January 5, 2009
June 18, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Tendon pathology as indicated by sonography
baseline, 3 weeks, 6 weeks, 4 months
Patient-Rated Global Change Score
3 weeks, 6 weeks, 4 months
Secondary Outcomes (4)
Pain Free Grip Strength
baseline, 3 weeks, 6 weeks, 4 months
Patient-rated Tennis Elbow Questionnaire
baseline, 3 weeks, 6 weeks, 4 months
Patient-Specific Functional Scale
baseline, 3 weeks, 6 weeks, 4 months
Adverse events
3 weeks, 6 weeks, 4 months
Study Arms (2)
Treatment 1
EXPERIMENTAL50 microamp amplitude
Treatment 2
EXPERIMENTAL500 microamp amplitude
Interventions
monophasic frequency modulated square wave current applied for 99 minutes daily for 21 days
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
- other pathology affecting distal upper limb
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
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
January 5, 2009
First Posted
January 6, 2009
Study Start
December 1, 2008
Primary Completion
December 1, 2009
Study Completion
December 1, 2009
Last Updated
June 22, 2010
Record last verified: 2009-08