Tennis ElbowNCT02236689
Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement
A study testing Non operative and Arthroscopic tennis elbow release in people with Tennis Elbow, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Non operative and Arthroscopic tennis elbow release
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 68 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2016to Dec 2025
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Symptoms consistent with lateral epicondylitis persisting for >6 months, and have failed conservative management
- Adult, skeletally mature (>18yrs)
- Provision of informed consent
Who cannot join
- Alternative diagnosis that better explain their symptoms
- Previous elbow trauma or surgery
- Case involving workplace insurance claims (e.g. WSIB)
- Unwilling, or unlikely in the opinion of the investigator to be followed for the duration of the study (e.g., patient refusal, unfixed address, plans to move...etc.)
- Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
- Bilateral lateral epicondylitis
Trial locations and contacts
1 site in 1 country.
J W Pollock, MD contact
Katie McIlquham contact
Canada1 site, 1 recruiting
- Recruiting
The Ottawa Hospital, General Campus
Ottawa, Ontario, K1H 8L6
J Pollock, MD, 613-737-8899 ext. 73031
J W Pollock, MD
About this study
Official title: A Randomized, Double-blind Controlled Trial Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement for the Management of Chronic Lateral Epicondylitis
We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better recommendations for the use of this procedure, in an effort to improve patient care.
Read the detailed description
Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a lifetime, most typically affecting individuals between the ages of 35 and 50.
Tennis elbow is a common occurrence in the general population that causes lateral elbow pain and diminished grip strength, which may be debilitating. Most affected individuals achieve symptom resolution within 6 months to 1 year with measures such as physiotherapy, anti-inflammatories and corticosteroid injections, but a small subset will go on to develop chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis elbow release (ATER), which has gained popularity in recent years as it presents a less invasive option, allows for direct visualization of the elbow joint for other pathology and has a faster return-to-work time compared to other surgical procedures. Despite its promise there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual efficacy of this procedure into question. A randomized controlled trial on arthroscopic tennis elbow release would provide much needed evidence in order to define its role in the management of tennis elbow and to help refine treatment protocols.
- Conditions
- Tennis Elbow
- Being tested
- Non operative, Arthroscopic tennis elbow release
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non operativeProcedure or surgery
no surgical intervention
Arthroscopic tennis elbow releaseProcedure or surgery
Patients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral).
| Study group | Role | What they receive |
|---|---|---|
| Arthroscopic tennis elbow release | Active comparator | This group will have arthroscopic tennis elbow release through a standard, two-portal technique, Receives: Procedure: Arthroscopic tennis elbow release |
| Non Operative | Placebo comparator | control group will not undergo a second portal or muscle release. Receives: Procedure: Non operative |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Mayo Elbow Performance Score
The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.
Measured: From baseline to up until 24-Months Post-Operative
Secondary outcomes (5)
Change in Disabilities of the Arm, Shoulder and Hand (DASH)
The Disabilities of the Arm, Shoulder and Hand (DASH), is a questionnaire that measures physical function and symptoms in those with an upper extremity disorder. The DASH is a 30 item questionnaire, each question is rated using a Likert scale. The question points are combined for a total of 100 points. A higher score indicates a worse outcome.
Measured: From baseline to up until 24-Months Post-Operative
Change in American Shoulder and Elbow Surgeons Elbow (ASES)
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Measured: From baseline to up until 24-Months Post-Operative
Change in Oxford Elbow Score (OES)
The Oxford Elbow Score (OES) is an outcome measure specific to patients who have had elbow surgery. The OES consists of 12 questions, looking into 3 domains: elbow function, pain, and social-psychological, using a Likert scale. Questions are summed, for a total score of 100 points. A higher score indicates a better outcome.
Measured: From time of enrollment up until 2-years post-operative
Change in Grip Strength
Grip strength will be measured using a hand-held dynamometer. Each participant will be asked to squeeze as much as they are comfortably able for approximately 3 seconds. 3 trials will be completed on each hand. Results will be averaged, and recorded in kilograms. Higher strength is a better outcome.
Measured: From time of enrollment up until 2-years post-operative
Adverse Events
Rates of study adverse events or serious adverse events (e.g. number of reoperations) will be monitored and recorded and compared between study groups. A higher rate of adverse events indicates a worse outcome.
Measured: Ongoing from time of enrollment, up until 24-months post-operative
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 startApr 2016
- Primary completionJun 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tennis ElbowStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 68 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- J W Pollock, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02236689
- Sponsor's protocol ID
- 20140553-01H
- Status last verified
- Nov 2023
- First submitted
- 8 Sep 2014
- Last updated
- 13 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Matache BA, Berdusco R, Momoli F, Lapner PL, Pollock JW. A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis. BMC Musculoskelet Disord. 2016 Jun 1;17:239. doi: 10.1186/s12891-016-1093-9.
PubMed 27245219
Study at a glance
From the registry record, last updated by the sponsor on 13 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind Controlled Trial Comparing Arthroscopic Tennis Elbow Release With Arthroscopic Debridement for the Management of Chronic Lateral Epicondylitis
- ClinicalTrials.gov ID
- NCT02236689
- Acronym / sponsor ID
- 20140553-01H
- Conditions
- Tennis Elbow
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 68 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Apr 2016 (actual)
- Primary completion
- Jun 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- 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.
We propose a randomized, double-blind controlled trial comparing arthroscopic release with arthroscopic debridement for the management of chronic tennis elbow in an effort to definitively determine whether arthroscopic tennis elbow release is an effective treatment of tennis elbow, and to further provide better recommendations for the use of this procedure, in an effort to improve patient care.
Detailed description
Lateral epicondylitis (tennis elbow) is a common occurrence in the general population with an incidence of 4-7/1000/year. More recent literature describes a 1-3% rate over the course of a lifetime, most typically affecting individuals between the ages of 35 and 50.
Tennis elbow is a common occurrence in the general population that causes lateral elbow pain and diminished grip strength, which may be debilitating. Most affected individuals achieve symptom resolution within 6 months to 1 year with measures such as physiotherapy, anti-inflammatories and corticosteroid injections, but a small subset will go on to develop chronic symptoms. Chronic tennis elbow can be treated surgically, by arthroscopic tennis elbow release (ATER), which has gained popularity in recent years as it presents a less invasive option, allows for direct visualization of the elbow joint for other pathology and has a faster return-to-work time compared to other surgical procedures. Despite its promise there have been no high quality studies evaluating the efficacy of arthroscopic tennis elbow release, bringing the actual efficacy of this procedure into question. A randomized controlled trial on arthroscopic tennis elbow release would provide much needed evidence in order to define its role in the management of tennis elbow and to help refine treatment protocols.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arthroscopic tennis elbow release | Active comparator | Procedure: Arthroscopic tennis elbow releaseThis group will have arthroscopic tennis elbow release through a standard, two-portal technique, |
| Non Operative | Placebo comparator | Procedure: Non operativecontrol group will not undergo a second portal or muscle release. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Symptoms consistent with lateral epicondylitis persisting for >6 months, and have failed conservative management
- Adult, skeletally mature (>18yrs)
- Provision of informed consent
Key exclusion criteria (6 listed)
- Alternative diagnosis that better explain their symptoms
- Previous elbow trauma or surgery
- Case involving workplace insurance claims (e.g. WSIB)
- Unwilling, or unlikely in the opinion of the investigator to be followed for the duration of the study (e.g., patient refusal, unfixed address, plans to move...etc.)
- Cognitive difficulties that prevent ability to provide informed consent and reliable completion of questionnaires
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 |
|---|---|---|
| Non operativeno surgical intervention | Procedure or surgery | Non Operative |
| Arthroscopic tennis elbow releasePatients randomized to Arthroscopic tennis elbow release (ATER) will receive arthroscopic release of the origin of the extensor carpi radialis brevis tendon through a standard, two-portal arthroscopic technique (medial and lateral). | Procedure or surgery | Arthroscopic tennis elbow release |
Primary outcome
Change in Mayo Elbow Performance Score
Time frame: From baseline to up until 24-Months Post-Operative
The Mayo Elbow Performance score is an outcome measure specific to the elbow to assess activities of daily living (ADLs). This outcome measure consists of 4 subscales: pain, range of motion, stability and daily function. Each section is combined for a total score out of 100 points. A higher score, indicates a better outcome.
5 secondary outcomes
Change in Disabilities of the Arm, Shoulder and Hand (DASH)
Time frame: From baseline to up until 24-Months Post-Operative
Change in American Shoulder and Elbow Surgeons Elbow (ASES)
Time frame: From baseline to up until 24-Months Post-Operative
Change in Oxford Elbow Score (OES)
Time frame: From time of enrollment up until 2-years post-operative
Change in Grip Strength
Time frame: From time of enrollment up until 2-years post-operative
Adverse Events
Time frame: Ongoing from time of enrollment, up until 24-months post-operative
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Nov 2023.
- Derived from this study: PubMed 27245219Matache BA, Berdusco R, Momoli F, Lapner PL, Pollock JW. A randomized, double-blind sham-controlled trial on the efficacy of arthroscopic tennis elbow release for the management of chronic lateral epicondylitis. BMC Musculoskelet Disord. 2016 Jun 1;17:239. doi: 10.1186/s12891-016-1093-9.
- Individual participant dataSharing planned: No
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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.
J W Pollock, MD contact
Katie McIlquham contact
J W Pollock, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non operative and Arthroscopic tennis elbow release in people with Tennis Elbow, run by Ottawa Hospital Research Institute 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 13 Nov 2023. 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact J W Pollock, MD (613-737-8899 ext. 73031), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Mayo Elbow Performance Score (time frame: From baseline to up until 24-Months Post-Operative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02236689, which also lists 1 linked publication.
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 13 Nov 2023.