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Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow (LE)

Primary Purpose

Tennis Elbow

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Kinesiotape
Counterforce elbow brace
Sponsored by
Lawson Health Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Tennis Elbow focused on measuring tennis elbow, treatment, lateral epicondylitis, immediate effects

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • The Hand and Upper Limb Centre, St. Joseph's Health Centre

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Kinesiotape (KT)

Counterforce elbow brace

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
July 4, 2013
Last Updated
September 8, 2014
Sponsor
Lawson Health Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT02235818
Brief Title
Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow
Acronym
LE
Official Title
Immediate Effectiveness of Counterforce Bracing Versus Kinesiotaping During Activity: A Randomized Crossover Trial in Patients With Lateral Epicondylosis
Study Type
Interventional

2. Study Status

Record Verification Date
September 2014
Overall Recruitment Status
Completed
Study Start Date
January 2013 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Lawson Health Research Institute

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tennis Elbow
Keywords
tennis elbow, treatment, lateral epicondylitis, immediate effects

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Kinesiotape (KT)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Counterforce elbow brace
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Kinesiotape
Other Intervention Name(s)
elastic tape, elastic therapeutic tape, kinesiotex tape
Intervention Description
Pre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm
Intervention Type
Device
Intervention Name(s)
Counterforce elbow brace
Other Intervention Name(s)
elbow strap, forearm brace, forearm strap
Intervention Description
Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace
Primary Outcome Measure Information:
Title
Pain free grip strength
Description
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.
Time Frame
initial visit
Secondary Outcome Measure Information:
Title
Pressure Pain Threshold
Description
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.
Time Frame
initial visit
Other Pre-specified Outcome Measures:
Title
Pain levels
Description
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.
Time Frame
initial visit

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy C Macdermid, PT, PhD
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Pritika Gogia, MSc
Organizational Affiliation
Western University, Canada
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hand and Upper Limb Centre, St. Joseph's Health Centre
City
London
State/Province
Ontario
ZIP/Postal Code
N6A 4L6
Country
Canada

12. IPD Sharing Statement

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Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow

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