Tennis ElbowEPICORENCT01390454
Relationships Between Ultrasound Data and the Impact of Lateral Epicondylar Pain
A study testing Ultrasound of the elbow 1, days 7 to 15, Ultrasound of the elbow 2, days 7 to 15 and Ultrasound of the elbow 3, days 45 to 90 in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Tennis Elbow, Epicondylitis, Lateral Humeral
- What is being tested?
- Ultrasound of the elbow 1, days 7 to 15, Ultrasound of the elbow 2, days 7 to 15 and Ultrasound of the elbow 3, days 45 to 90
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 5 Mar 2012to 18 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 90 days of follow up
- Pain when pressure applied to the epicondyl
- Pain upon forced movement of both epicondylien muscles
- Absence of pain upon forced movement of an epitrochlear muscle
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- Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow
- at least one consult for pain treatment associated with tennis elbow (on the same elbow)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- No pain when pressure applied to the epicondyl
- No pain upon forced movement of both epicondylien muscles
- No neck pain
- No skeletal-muscle problems in the arms during the 3 months preceding the study
Who cannot join
- The patient is included in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
- The patient is pregnant
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- The patient is breastfeeding
- Absence of one or more skeletal-muscle problem on the homolateral arm felt by the patient to be just as problematic as his/her tennis elbow
- The subject is included in another study
- The subject is in an exclusion period determined by a previous study
- The subject is under judicial protection, under tutorship or curatorship
- The subject refuses to sign the consent
- It is impossible to correctly inform the subject
- Presence of one or more skeletal-muscle problems in the arms within the 3 months preceding the study
- Pain when pressure applied to the epicondyl
- Pain upon forced movement of both epicondylien muscles
- Consultation for any kind of treatment for elbow pain
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain
Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Being tested
- Ultrasound of the elbow 1, days 7 to 15, Ultrasound of the elbow 2, days 7 to 15, Ultrasound of the elbow 3, days 45 to 90
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound of the elbow 1, days 7 to 15Procedure or surgery
The primary endpoint is evaluated a first time via an ultrasound exam.
Ultrasound of the elbow 2, days 7 to 15Procedure or surgery
The primary endpoint is evaluated a second time by a second practitioner.
Ultrasound of the elbow 3, days 45 to 90Procedure or surgery
A third ultrasound is performed only on tennis elbow patients between days 45 and 90.
| Study group | Role | What they receive |
|---|---|---|
| Tennis elbow patients | Experimental | These patients have tennis elbow, according to stated inclusion criteria. Receives: Procedure: Ultrasound of the elbow 1, days 7 to 15; Procedure: Ultrasound of the elbow 2, days 7 to 15; Procedure: Ultrasound of the elbow 3, days 45 to 90 |
| Healthy volunteers | Active comparator | Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness. Receives: Procedure: Ultrasound of the elbow 1, days 7 to 15; Procedure: Ultrasound of the elbow 2, days 7 to 15 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)
The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.
Measured: Days 7 to 15
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)
The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.
Measured: Days 7 to 15
Secondary outcomes (7)
Visual Analog Scale for pain
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Measured: Baseline
Visual Analog Scale for pain
A visual analog scale ranging from 0 to 100 is used to evaluate pain.
Measured: Between days 45 and 90
Q-Dash Questionnaire
The Quick DASH questionnaire is used to evaluate functional changes.
Measured: Baseline
Q-Dash Questionnaire
The Quick DASH questionnaire is used to evaluate functional changes.
Measured: Between 45 and 90 days
Thickness of the ECR longus and ECR brevis interface
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Measured: Between days 7 and 15
Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only
The thickness of the interface between the extensor carpi radialis (ECR) longus and the extensor carpi radialis brevis is measured during the ultrasound (mm)
Measured: Between days 45 and 90
Thickness of the ECR -supinator interface
The thickness of the intersection (at the base) between the Extensor Carpi Radialis (ECR) muscles and the supinator is measured during ultrasound (mm)
Measured: Between 7 and 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2011 (estimated)
- Study start5 Mar 2012
- Primary completion18 Jun 2013
- Study completion18 Jun 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 Centre Hospitalier Universitaire de NīmesThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Dupeyron, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01390454
- Sponsor's protocol ID
- LOCAL/2010/AD-03b
- Other IDs
- 2011-A00769-32
- Acronym
- EPICORE
- Status last verified
- Mar 2018
- First submitted
- 7 Jul 2011
- Last updated
- 30 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Relationship Between Functional Ultrasound Data and the Impact of Lateral Epicondylar Pain
- ClinicalTrials.gov ID
- NCT01390454
- Acronym / sponsor ID
- EPICORE / LOCAL/2010/AD-03b
- Conditions
- Tennis Elbow, Epicondylitis, Lateral Humeral
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 5 Mar 2012 (actual)
- Primary completion
- 18 Jun 2013 (actual)
- Study completion
- 18 Jun 2013 (actual)
- First posted
- 11 Jul 2011 (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.
Our primary objective is to study the relationship between ultra sound data and the pain associated with tennis elbow.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tennis elbow patients | Experimental | Procedure: Ultrasound of the elbow 1, days 7 to 15, Procedure: Ultrasound of the elbow 2, days 7 to 15, Procedure: Ultrasound of the elbow 3, days 45 to 90These patients have tennis elbow, according to stated inclusion criteria. |
| Healthy volunteers | Active comparator | Procedure: Ultrasound of the elbow 1, days 7 to 15, Procedure: Ultrasound of the elbow 2, days 7 to 15Healthy volunteers are selected and paired according to age, sex, socio-professional category and left- or right-handedness. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- The patient must have given his/her informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- The patient is available for 90 days of follow up
- Pain when pressure applied to the epicondyl
- Pain upon forced movement of both epicondylien muscles
Key exclusion criteria (17 listed)
- The patient is included in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection, under tutorship or curatorship
- The patient refuses to sign the consent
- It is impossible to correctly inform the patient
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 |
|---|---|---|
| Ultrasound of the elbow 1, days 7 to 15The primary endpoint is evaluated a first time via an ultrasound exam. | Procedure or surgery | Healthy volunteers, Tennis elbow patients |
| Ultrasound of the elbow 2, days 7 to 15The primary endpoint is evaluated a second time by a second practitioner. | Procedure or surgery | Healthy volunteers, Tennis elbow patients |
| Ultrasound of the elbow 3, days 45 to 90A third ultrasound is performed only on tennis elbow patients between days 45 and 90. | Procedure or surgery | Tennis elbow patients |
Primary outcome
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow)
Time frame: Days 7 to 15
The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (good elbow)
Time frame: Days 7 to 15
The movement of the superficial epicondyliens relative to the supinator is studied via ultrasound and classified as follows: A) good interface movement in both directions; B) good movement in only 1 direction; C) bad movement over less than half of the interface; D) bad movement over a majority of the interface; E) no movement along the interface.
7 secondary outcomes
Visual Analog Scale for pain
Time frame: Baseline
Visual Analog Scale for pain
Time frame: Between days 45 and 90
Q-Dash Questionnaire
Time frame: Baseline
Q-Dash Questionnaire
Time frame: Between 45 and 90 days
Thickness of the ECR longus and ECR brevis interface
Time frame: Between days 7 and 15
Thickness of the ECR longus and ECR brevis interface, tennis elbow patients only
Time frame: Between days 45 and 90
Thickness of the ECR -supinator interface
Time frame: Between 7 and 15 days
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 30 Mar 2018.
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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.
Arnaud Dupeyron, MD PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound of the elbow 1, days 7 to 15, Ultrasound of the elbow 2, days 7 to 15 and Ultrasound of the elbow 3, days 45 to 90 in people with Tennis Elbow and Epicondylitis, Lateral Humeral, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
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 14 inclusion and 17 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 30 Mar 2018. 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 France. 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?
Epicondylar surface movement relative to the supinators - extensor carpi radialis brevis and longus (affected elbow) (time frame: Days 7 to 15). The study lists 2 primary outcomes in all. 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 30 Mar 2018.