- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02235818
Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow (LE)
September 8, 2014 updated by: Joy MacDermid, Lawson Health Research Institute
Immediate Effectiveness of Counterforce Bracing Versus Kinesiotaping During Activity: A Randomized Crossover Trial in Patients With Lateral Epicondylosis
The purpose of this study was to compare the immediate efficacy of Counterforce brace versus kinesiotaping on patients with lateral epicondylosis/tennis elbow with respect to a repetitive physical task.
The investigators hypothesized that there would be difference in the outcomes with respect to interventions and activity.
Patient came for one hour long Single occasion testing session and were not followed up after the testing was complete.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
This was a cross over randomized control trial.
Thirty patients with clinical diagnosis of lateral epicondylosis/tennis elbow were recruited from a local community and were tested on single occasion (one time testing session) before and after a five minute upper extremity repetitive task first with control and then brace and kinesiotape assigned in cross-over design.
The testing session was one hour long and there was no follow up of patients following the testing.
The patients were recruited between Jan-June 2013.
Study Type
Interventional
Enrollment (Actual)
30
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Ontario
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London, Ontario, Canada, N6A 4L6
- The Hand and Upper Limb Centre, St. Joseph's Health Centre
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age (18-70 years)
- Ability to provide written informed consent to participate
- Were at least three weeks from onset of symptoms
- Complaints of discomfort or pain at the lateral elbow region for a minimum of three weeks and tenderness with palpation of the lateral epicondyle
- Provocation of lateral elbow pain with one of the following test - resisted middle finger extension, resisted wrist extension or passive stretch of wrist extensors
Exclusion Criteria:
- History of surgery on affected elbow
- History of cortisone injections on the affected elbow in the past 4 weeks
- Any physical or mental limitations that precluded performance of the study testing
- Allergy to adhesive tapes
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Kinesiotape (KT)
Kinesiotape was used only on the affected side as per the manufacturer instructions.
With the elbow extended, wrist fully flexed and fingers pointed down 24, KT was applied with slight stretch (10-15%) and paper off tension to the lateral arm beginning just above the bony portion of lateral epicondyle.
Once the top strand was anchored, KT was applied along the side of elbow such that hole in the tape was over lateral epicondyle of the elbow.
Two strands of tape followed the lateral forearm and ended at around beginning of the distal one third of forearm.
Once the support was applied, KT was gently rubbed to activate the glue.
|
Pre-cut kinesiotape for tennis elbow, spidertech.com,
applied on wrist extensors starting above elbow and ending at distal one third of forearm
Other Names:
|
|
Active Comparator: Counterforce elbow brace
The counterforce brace was approximately 5cm wide with velcro attachment for adjustable girth.
It had gel pack for extra support on extensor muscle mass.
With the elbow extended, brace was applied 2.5cms below the lateral epicondyle.
A feeling of comfortable compression, as reported by the patients was used to adjust the brace.
|
Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain free grip strength
Time Frame: initial visit
|
Pain free grip strength was recorded with J-tech medical dynamometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.
|
initial visit
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pressure Pain Threshold
Time Frame: initial visit
|
Pressure Pain Threshold was recorded with J-tech medical Algometer before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.
|
initial visit
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Pain levels
Time Frame: initial visit
|
Pain levels were recorded with Numeric Pain Rating scale before and after five minutes of repetitive physical exposure with first control (no intervention) and then brace and kinesiotape assigned randomly in cross-over fashion.
|
initial visit
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Joy C Macdermid, PT, PhD, Western University, Canada
- Principal Investigator: Pritika Gogia, MSc, Western University, Canada
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2013
Primary Completion (Actual)
June 1, 2013
Study Completion (Actual)
June 1, 2013
Study Registration Dates
First Submitted
July 4, 2013
First Submitted That Met QC Criteria
September 8, 2014
First Posted (Estimate)
September 10, 2014
Study Record Updates
Last Update Posted (Estimate)
September 10, 2014
Last Update Submitted That Met QC Criteria
September 8, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- HSREB103099
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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