EpicondylitisPhase 3EPITOXNCT03380559
A Phase III Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
A Phase 3 study testing Injection, botulinum toxin + corticoid in people with Epicondylitis, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Epicondylitis
- What is being tested?
- Injection, botulinum toxin + corticoid
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 19 Apr 2019to 19 Aug 2021
- Phase
- Phase 3
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patient aged between 18 and 60 years;
- Physical disability or not;
- Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;
- Signed consent obtained;
- Covered by health insurance.
Who cannot join
- Central nervous system disorders result in spasticity in epicondylitis limb;
- History of severe psychiatric disorder;
- History of myasthenia gravis;
- Pregnant or breastfeeding woman;
- Unable to understand or respond to questions;
- Contraindication to botulinum toxin or corticoid;
Show all 10Show fewer
- Treatment with botulinum toxin 3 months prior to baseline;
- Anticoagulant theraphy;
- Difficult to follow-up in the study;
- Patient under guardianship, or deprived of liberty by a judicial order.
Trial locations and contacts
1 site in 1 country.
France1 site
Service de Médecine Physique et de Réadaptation, Hôpital Raymond Poincaré
Garches, Hauts-de-Seine, 92380
About this study
Official title: A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.
As secondary objectives, the study aims to
- demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
- evaluate tolerance of treatment by grip strength measurement and adverse event collection.
Read the detailed description
This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.
All patients will be randomized in 3 following parallel treatment groups:
Group A : botulinum toxin + corticoid
Group C : placebo of toxin + corticoid
Group T : botulinum toxin + placebo corticoid
The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.
- Conditions
- Epicondylitis
- Being tested
- Injection, botulinum toxin + corticoid, Injection, placebo of toxin + corticoid, Injection, botulinum toxin + placebo corticoid
- Keywords
- Epicondylitis, Botulinum toxin, Corticoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Injection, botulinum toxin + corticoidDrug
- Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
- Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
Injection, placebo of toxin + corticoidDrug
- Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control
- Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %)
Injection, botulinum toxin + placebo corticoidDrug
- Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control
- Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %)
| Study group | Role | What they receive |
|---|---|---|
| Group A : Association (botulinum toxin + corticoid) | Experimental | Not described Receives: Drug: Injection, botulinum toxin + corticoid |
| Group C : placebo of toxin + corticoid : | Placebo comparator | Not described Receives: Drug: Injection, placebo of toxin + corticoid |
| Group T : botulinum toxin + placebo corticoid | Active comparator | Not described Receives: Drug: Injection, botulinum toxin + placebo corticoid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation of pain intensity between injection of treatment and 6 months after injection
Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS).
Measured: At the moment of injection
Variation of pain intensity between injection of treatment and 6 months after injection
Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS.
Measured: 6 months after injection
Secondary outcomes (9)
Spontaneous pain intensity at rest
Evaluate pain intensity at rest with the VAS.
Measured: Before injection, 3 months after injection and 6 months after injection
Pain intensity of motion of wrist flexion
Evaluate pain intensity of motion of wrist flexion with the VAS.
Measured: Before injection, 3 months after injection and 6 months after injection
Pain intensity at proximal insertion palpation on epicondylitis muscle
Evaluate pain intensity at proximal insertion palpation on epicondylitis muscle. The palpation will be under ultrasound control.
Measured: Before injection, 3 months after injection and 6 months after injection
Number of days of sick leave
Number of days of sick leave will be noted and collected
Measured: 6 months after injection
The percentage of patients returning to professional activity or sportive activity
Measured: 6 months after injection
Measurement of prehensile grasp capabilities by a force
The force will be measured by Jamar Hydraulic hand dynamometer.
Measured: At baseline, 3 months after injection, 6 months after injection
Functional outcome after injection
Outcome will be evaluated by questionnaire Patient Rated Tennis Elbow Evaluation
Measured: At baseline, 3 months after injection, 6 months after injection
Anxiety and depression tests
Hospital Anxiety and Depression scale will be used
Measured: At baseline, 3 months after injection, 6 months after injection
Frequence and gravity of adverse events
Adverse events will be collected and their severity will be reported.
Measured: At baseline, 3 months after injection, 6 months after injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2017
- Study start19 Apr 2019
- Primary completion7 Jul 2021
- Study completion19 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EpicondylitisStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Ratio 1:1:1
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- François Genêt, MD, PhD, Study chair, Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03380559
- Sponsor's protocol ID
- P160926J
- Other IDs
- 2017-001709-33, 2017
- Acronym
- EPITOX
- Status last verified
- Sep 2023
- First submitted
- 11 Dec 2017
- Last updated
- 21 Sep 2023
- 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 21 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III Randomized Double-blind Study to Evaluate Efficacy of Botulinum Toxin for Treating Epicondylitis
- ClinicalTrials.gov ID
- NCT03380559
- Acronym / sponsor ID
- EPITOX / P160926J
- Conditions
- Epicondylitis
- Keywords
- Epicondylitis, Botulinum toxin, Corticoid
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- 19 Apr 2019 (actual)
- Primary completion
- 7 Jul 2021 (actual)
- Study completion
- 19 Aug 2021 (actual)
- First posted
- 21 Dec 2017 (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.
The study aims to demonstrate that intramuscular injection of botulinum toxin with a paralyzing dose coupled with subcutaneous injection of corticoid has greater efficacy than corticoid injection only or toxin injection only for treating lateral epicondylitis in reducing pain at 6 months.
As secondary objectives, the study aims to
- demonstrate improvement of quality of patient's life and positive effect on their resuming to professional activities or sportive activities.
- evaluate tolerance of treatment by grip strength measurement and adverse event collection.
Detailed description
This is a prospective multicenter phase IIIb randomized double-blind placebo-controlled study, to compare efficacy and tolerance of 3 groups of treatments for epicondylitis.
All patients will be randomized in 3 following parallel treatment groups:
Group A : botulinum toxin + corticoid
Group C : placebo of toxin + corticoid
Group T : botulinum toxin + placebo corticoid
The study will be performed in 4 centers in France, targetting 150 patients. The follow-up of each patient will last 6 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Ratio 1:1:1
| Arm | Type | Receives |
|---|---|---|
| Group A : Association (botulinum toxin + corticoid) | Experimental | Drug: Injection, botulinum toxin + corticoid |
| Group C : placebo of toxin + corticoid : | Placebo comparator | Drug: Injection, placebo of toxin + corticoid |
| Group T : botulinum toxin + placebo corticoid | Active comparator | Drug: Injection, botulinum toxin + placebo corticoid |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patient aged between 18 and 60 years;
- Physical disability or not;
- Unilateral lateral epicondylitis more than 3 months, recurrent or not, no response to at least one standard treatment such as: local injection of corticoid, physiotherapy, rest, NSAIDs per os;
- Signed consent obtained;
- Covered by health insurance.
Key exclusion criteria (10 listed)
- Central nervous system disorders result in spasticity in epicondylitis limb;
- History of severe psychiatric disorder;
- History of myasthenia gravis;
- Pregnant or breastfeeding woman;
- Unable to understand or respond to questions;
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 |
|---|---|---|
| Injection, botulinum toxin + corticoid* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %) | Drug | Group A : Association (botulinum toxin + corticoid) |
| Injection, placebo of toxin + corticoid* Intramuscular injection of placebo botulinum toxin (2 ml) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of corticoid (2 ml of Hydrocortancyl® 2,5 %) | Drug | Group C : placebo of toxin + corticoid : |
| Injection, botulinum toxin + placebo corticoid* Intramuscular injection of botulinum toxin (Xeomin® 50 U) under ultrasound control * Subcutaneous injection (lateral epicondylitis side) of placebo of corticoid (2 ml of physiological saline solution NaCL 0.9 %) | Drug | Group T : botulinum toxin + placebo corticoid |
Primary outcome
Variation of pain intensity between injection of treatment and 6 months after injection
Time frame: At the moment of injection
Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the Visual Analogue Scale (VAS).
Variation of pain intensity between injection of treatment and 6 months after injection
Time frame: 6 months after injection
Evaluate the variation of muscle pain intensity in wrist extensor contractions between the moment of injection and the end of the 6th month with the VAS.
9 secondary outcomes
Spontaneous pain intensity at rest
Time frame: Before injection, 3 months after injection and 6 months after injection
Pain intensity of motion of wrist flexion
Time frame: Before injection, 3 months after injection and 6 months after injection
Pain intensity at proximal insertion palpation on epicondylitis muscle
Time frame: Before injection, 3 months after injection and 6 months after injection
Number of days of sick leave
Time frame: 6 months after injection
The percentage of patients returning to professional activity or sportive activity
Time frame: 6 months after injection
Measurement of prehensile grasp capabilities by a force
Time frame: At baseline, 3 months after injection, 6 months after injection
Functional outcome after injection
Time frame: At baseline, 3 months after injection, 6 months after injection
Anxiety and depression tests
Time frame: At baseline, 3 months after injection, 6 months after injection
Frequence and gravity of adverse events
Time frame: At baseline, 3 months after injection, 6 months after injection
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 21 Sep 2023.
- Individual participant dataSharing planned: No
Related trials for Epicondylitis
Not yet recruitingObservational study
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A Comparison of the Effects of Combining ESWT With Blood Flow Restriction Therapy in Patients Diagnosed With Lateral Epicondylitis
Lateral Epicondylitis
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Effect of Ultrasound-Guided Posterior Cutaneous Nerve of the Forearm Epicondylar Branch Block on Pain and Function in Lateral Epicondylitis (PCNF-BrEpi)
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Comparing Surgical and Nonsurgical Outcomes of Tennis Elbow
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Comparative Effectiveness of Ultrasound-Guided Tenoxicam and Corticosteroid Injections for Lateral Epicondylitis
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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.
François Genêt, MD, PhD study chair
Service de Médecine Physique et de Réadaptation Hôpital Raymond Poincaré
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Injection, botulinum toxin + corticoid in people with Epicondylitis, run by Assistance Publique - Hôpitaux de Paris 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 5 inclusion and 10 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 21 Sep 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 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. 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Variation of pain intensity between injection of treatment and 6 months after injection (time frame: At the moment of injection). 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 21 Sep 2023.