Tennis ElbowLENCT02235818
Determining the Immediate Effects of Counterforce Bracing Versus Kinesiotaping in Patients With Tennis Elbow
A study testing Kinesiotape and Counterforce elbow brace in people with Tennis Elbow, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Kinesiotape and Counterforce elbow brace
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2013to Jun 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Canada1 site
The Hand and Upper Limb Centre, St. Joseph's Health Centre
London, Ontario, N6A 4L6
About this study
Official title: 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.
Read the 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.
- Conditions
- Tennis Elbow
- Being tested
- Kinesiotape, Counterforce elbow brace
- Keywords
- tennis elbow, treatment, lateral epicondylitis, immediate effects
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KinesiotapeDevice
Also called elastic tape, elastic therapeutic tape, kinesiotex tape
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 braceDevice
Also called elbow strap, forearm brace, forearm strap
Applied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace
| Study group | Role | What they receive |
|---|---|---|
| Kinesiotape (KT) | Active comparator | 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. Receives: Device: Kinesiotape |
| Counterforce elbow brace | Active comparator | 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. Receives: Device: Counterforce elbow brace |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: initial visit
Secondary outcomes (1)
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.
Measured: initial visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Sep 2014 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joy MacDermid, London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
- Investigators
- Joy C Macdermid, PT, PhD, Principal investigator, Western University, CanadaPritika Gogia, MSc, Principal investigator, Western University, Canada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02235818
- Sponsor's protocol ID
- HSREB103099
- Acronym
- LE
- Status last verified
- Sep 2014
- First submitted
- 4 Jul 2013
- Last updated
- 10 Sep 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immediate Effectiveness of Counterforce Bracing Versus Kinesiotaping During Activity: A Randomized Crossover Trial in Patients With Lateral Epicondylosis
- ClinicalTrials.gov ID
- NCT02235818
- Acronym / sponsor ID
- LE / HSREB103099
- Conditions
- Tennis Elbow
- Keywords
- tennis elbow, treatment, lateral epicondylitis, immediate effects
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph'sUniversity, hospital or other
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 10 Sep 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Kinesiotape (KT) | Active comparator | Device: KinesiotapeKinesiotape 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. |
| Counterforce elbow brace | Active comparator | Device: Counterforce elbow braceThe 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KinesiotapeAlso: elastic tape, elastic therapeutic tape, kinesiotex tapePre-cut kinesiotape for tennis elbow, spidertech.com, applied on wrist extensors starting above elbow and ending at distal one third of forearm | Device | Kinesiotape (KT) |
| Counterforce elbow braceAlso: elbow strap, forearm brace, forearm strapApplied over the wrist extensor muscle mass, had velcro for adjustment, comfortable grip as reported by patient was used to adjust the brace | Device | Counterforce elbow brace |
Primary outcome
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.
1 secondary outcome
Pressure Pain Threshold
Time frame: initial visit
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joy C Macdermid, PT, PhD principal investigator
Western University, Canada
Pritika Gogia, MSc principal investigator
Western University, Canada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Kinesiotape and Counterforce elbow brace in people with Tennis Elbow, run by London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain free grip strength (time frame: initial visit). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2014.