Lateral EpicondylitisEPITOXNCT06765694
Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study (EPITOX)
An observational study of Lateral Epicondylitis, run by University Hospital, Brest at 1 site in France.
Trial summary
Despite being a self-limiting injury, lateral epicondylitis (LE) can be difficult to manage. In cases of refractory LE, conservative treatment fails and symptoms persist over 6 months. Previous studies have investigated the role of botulinum Toxin Type A (BoNT-A) injections in LE with controversial results. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Lateral Epicondylitis
- What is being tested?
- Botulinum toxin injection
- Type of treatment
- Injection or infusion
- How many people
- 80 participants
- Where
- 1 siteFrance
- Study dates
- 1 Nov 2024to 31 Oct 2025
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: subjects with chronic lateral epicondylitis already treated by physiotherapy, shock wave therapy, steroid injections without relief of pain
Who may be able to join
- lateral epicondylitis at least one botulinum injection
Who cannot join
- none
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study
Despite being a self-limiting injury, lateral epicondylitis (LE) can be difficult to manage. In cases of refractory LE, conservative treatment fails and symptoms persist over 6 months. Previous studies have investigated the role of botulinum Toxin Type A (BoNT-A) injections in LE with controversial results. There is some evidence that repeating the BoNT-A injection could be beneficial for refractory cases.
The objective is to assess the success rate of one or two BoNT-A injections for refractory LE.
- Conditions
- Lateral Epicondylitis
- Being tested
- Botulinum toxin injection
- Medical subject headings
- Tennis Elbow
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin injectionDrug
first injection was done under ultrasound control in the extensor carpi radialis brevis (ECRB). The second one if necessary was subordinated to clinical examination and focused in one or more of the following: ECRB, extensor digitorum communis, supinator.
| Study group | Role | What they receive |
|---|---|---|
| epicondylitis with BTX injection | Subjects included were addressed to a unique physician who performed all the treatment procedure with a diagnostic of lateral epicondylitis to receive a BTX injection. Receives: Drug: Botulinum toxin injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain improvement
A qualitative scale was used to define the result of the treatment procedure based on pain improvement.
Poor : no improvement Temporary : significant but temporary pain reduction Partial : permanent but partial pain reduction Good : patient no longer requesting any treatment for LE due to pain relief
Measured: from enrollment to 6 months
Secondary outcomes (1)
adverse events
Any adverse event was notified
Measured: from enrollment to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2025
- Study start1 Nov 2024
- Primary completion31 Oct 2025 (estimated)
- Study completion31 Oct 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lateral EpicondylitisStudies of the same condition, open and under way.
- More trials run by University Hospital, BrestThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Brest
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06765694
- Sponsor's protocol ID
- 29BRC24.0278 - EPITOX
- Acronym
- EPITOX
- Status last verified
- Sep 2024
- First submitted
- 27 Dec 2024
- Last updated
- 9 Jan 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of One or Two Botulinum Toxin Injections in the Treatment of Chronic Lateral Epicondylalgia: a Retrospective Study
- ClinicalTrials.gov ID
- NCT06765694
- Acronym / sponsor ID
- EPITOX / 29BRC24.0278 - EPITOX
- Conditions
- Lateral Epicondylitis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, BrestUniversity, hospital or other
- Study start
- 1 Nov 2024 (actual)
- Primary completion
- 31 Oct 2025 (estimated)
- Study completion
- 31 Oct 2025 (estimated)
- First posted
- 9 Jan 2025 (actual)
- 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.
Despite being a self-limiting injury, lateral epicondylitis (LE) can be difficult to manage. In cases of refractory LE, conservative treatment fails and symptoms persist over 6 months. Previous studies have investigated the role of botulinum Toxin Type A (BoNT-A) injections in LE with controversial results. There is some evidence that repeating the BoNT-A injection could be beneficial for refractory cases.
The objective is to assess the success rate of one or two BoNT-A injections for refractory LE.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| epicondylitis with BTX injection | – | Drug: Botulinum toxin injectionSubjects included were addressed to a unique physician who performed all the treatment procedure with a diagnostic of lateral epicondylitis to receive a BTX injection. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- subjects with chronic lateral epicondylitis already treated by physiotherapy, shock wave therapy, steroid injections without relief of pain
Key inclusion criteria (1 listed)
- lateral epicondylitis at least one botulinum injection
Key exclusion criteria (1 listed)
- none
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 |
|---|---|---|
| Botulinum toxin injectionfirst injection was done under ultrasound control in the extensor carpi radialis brevis (ECRB). The second one if necessary was subordinated to clinical examination and focused in one or more of the following: ECRB, extensor digitorum communis, supinator. | Drug | epicondylitis with BTX injection |
Primary outcome
pain improvement
Time frame: from enrollment to 6 months
A qualitative scale was used to define the result of the treatment procedure based on pain improvement. Poor : no improvement Temporary : significant but temporary pain reduction Partial : permanent but partial pain reduction Good : patient no longer requesting any treatment for LE due to pain relief
1 secondary outcome
adverse events
Time frame: from enrollment to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lateral Epicondylitis, run by University Hospital, Brest 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 1 inclusion and 1 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 9 Jan 2025. 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?
Results are not available in the source record.
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 improvement (time frame: from enrollment to 6 months). 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 9 Jan 2025.