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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02235818
Other study ID # HSREB103099
Secondary ID
Status Completed
Phase N/A
First received July 4, 2013
Last updated September 8, 2014
Start date January 2013
Est. completion date June 2013

Study information

Verified date September 2014
Source Lawson Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 30
Est. completion date June 2013
Est. primary completion date June 2013
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria:

1. Age (18-70 years)

2. Ability to provide written informed consent to participate

3. Were at least three weeks from onset of symptoms

4. Complaints of discomfort or pain at the lateral elbow region for a minimum of three weeks and tenderness with palpation of the lateral epicondyle

5. 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:

1. History of surgery on affected elbow

2. History of cortisone injections on the affected elbow in the past 4 weeks

3. Any physical or mental limitations that precluded performance of the study testing

4. Allergy to adhesive tapes

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Kinesiotape
Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm
Counterforce elbow brace
Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace

Locations

Country Name City State
Canada The Hand and Upper Limb Centre, St. Joseph's Health Centre London Ontario

Sponsors (1)

Lead Sponsor Collaborator
Lawson Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Other Pain levels 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 No
Primary Pain free grip strength 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 No
Secondary Pressure Pain Threshold 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 No
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