Tennis ElbowPhase 3TBANCT00437762
Effectiveness of Botulinum Toxin Injection in the Tennis Elbow Treatment
A Phase 3 study testing Botulinum Toxin A Injection in people with Tennis Elbow, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Tennis Elbow
- What is being tested?
- Botulinum Toxin A Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 61 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2007to Jun 2012
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Tennis elbow during more than 6 months
- Signature of consent
Who cannot join
- Less than 18 years old
- Osteoarthritis elbow
- Referred cervical pain
- Fibromyalgia
- Pregnancy
- Myasthenia
Show all 13Show fewer
- Polymyositis
- SLA
- Anticoagulant treatment
- Aminosides
- Diabetes
- Alcoholism
- Previous botulinum toxin A injections
Trial locations and contacts
1 site in 1 country.
France1 site
Unité de médecine orthopédique- Hôpital Pellegrin RDC aile 2.
Bordeaux, 330076
About this study
Official title: Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo
Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
Read the detailed description
- Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
- Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
- Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
- Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
- Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
- Study plan: randomized parallel groups
- Number of subjects : 60
- Conditions
- Tennis Elbow
- Being tested
- Botulinum Toxin A Injection, Placebo injection
- Keywords
- Lateral epicondylitis, tennis elbow, treatment
- 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 A InjectionDrug
Botulinum Toxin A Injection
Placebo injectionDrug
Placebo Injection
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Botulinum Toxin A Injection Receives: Drug: Botulinum Toxin A Injection |
| 2 | Placebo comparator | Placebo injection Receives: Drug: Placebo injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Principal criteria of assessment is pain intensity three months after injection.
Measured: at 3 month
Secondary outcomes (5)
pain intensity
Measured: to day 30, 90,180, 365
Number of painful days
Measured: to day 30, 90,180, 365
Number of associated treatments.
Measured: to day 30, 90,180, 365
Free pain grip strength
Measured: to day 30, 90,180, 365
Rate of recidivism after initial relief
Measured: to day 30, 90,180, 365
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2007 (estimated)
- Study startApr 2007
- Primary completionJun 2012
- Study completionJun 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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 University Hospital, BordeauxThe 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
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 61 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Mathieu DE SEZE, MD, Principal investigator, University Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00437762
- Sponsor's protocol ID
- CHUBX 2005/08
- Acronym
- TBA
- Status last verified
- Feb 2013
- First submitted
- 19 Feb 2007
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Cogne M, Petit H, Creuze A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6.
PubMed 29141611Creuze A, Petit H, de Seze M. Short-Term Effect of Low-Dose, Electromyography-Guided Botulinum Toxin A Injection in the Treatment of Chronic Lateral Epicondylar Tendinopathy: A Randomized, Double-Blinded Study. J Bone Joint Surg Am. 2018 May 16;100(10):818-826. doi: 10.2106/JBJS.17.00777.
PubMed 29762276
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Botulinum Toxin A Injection for the Treatment of Lateral Epicondylitis Unrelieved by Usual Medical Cares : A Double Blind Randomized Controlled Trial Versus Placebo
- ClinicalTrials.gov ID
- NCT00437762
- Acronym / sponsor ID
- TBA / CHUBX 2005/08
- Conditions
- Tennis Elbow
- Keywords
- Lateral epicondylitis, tennis elbow, treatment
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Apr 2007
- Primary completion
- Jun 2012 (actual)
- Study completion
- Jun 2012 (actual)
- First posted
- 21 Feb 2007 (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.
Some studies valued the effectiveness of botulinum toxin. Results are contradictory and we need more studies. The purpose of the study is to compare the effectiveness of botulinum toxin injection with placebo in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months. Method : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
Detailed description
- Principal Objective : The first aim of the study is to value the effectiveness of botulinum toxin injection in the treatment of tennis elbow unrelieved by usual medical care performed during 6 months..
- Secondary Objective : The second aim of this study is to document the tennis elbow history by a one year following after initial injection
- Study design : It is a double blind randomized controlled trial. Principal criteria of assessment is Pain intensity three months after injection.
- Inclusion criteria : tennis elbow during more than 6 months ; signature of consent
- Exclusion criteria : Non inclusion criteria : less than 18 years old ; osteoarthritis elbow, referred cervical pain, fibromyalgia, pregnancy, myasthenia, polymyositis, SLA, anticoagulant treatment, aminosides ; diabetes, alcoholism
- Study plan: randomized parallel groups
- Number of subjects : 60
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: Botulinum Toxin A InjectionBotulinum Toxin A Injection |
| 2 | Placebo comparator | Drug: Placebo injectionPlacebo injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Tennis elbow during more than 6 months
- Signature of consent
Key exclusion criteria (13 listed)
- Less than 18 years old
- Osteoarthritis elbow
- Referred cervical pain
- Fibromyalgia
- Pregnancy
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 A InjectionBotulinum Toxin A Injection | Drug | 1 |
| Placebo injectionPlacebo Injection | Drug | 2 |
Primary outcome
Principal criteria of assessment is pain intensity three months after injection.
Time frame: at 3 month
5 secondary outcomes
pain intensity
Time frame: to day 30, 90,180, 365
Number of painful days
Time frame: to day 30, 90,180, 365
Number of associated treatments.
Time frame: to day 30, 90,180, 365
Free pain grip strength
Time frame: to day 30, 90,180, 365
Rate of recidivism after initial relief
Time frame: to day 30, 90,180, 365
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 14 May 2026.
- Results publication: PubMed 29141611Cogne M, Petit H, Creuze A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6.
- Results publication: PubMed 29762276Creuze A, Petit H, de Seze M. Short-Term Effect of Low-Dose, Electromyography-Guided Botulinum Toxin A Injection in the Treatment of Chronic Lateral Epicondylar Tendinopathy: A Randomized, Double-Blinded Study. J Bone Joint Surg Am. 2018 May 16;100(10):818-826. doi: 10.2106/JBJS.17.00777.
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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.
Mathieu DE SEZE, MD principal investigator
University Hospital, Bordeaux
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 Botulinum Toxin A Injection in people with Tennis Elbow, run by University Hospital, Bordeaux 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 2 inclusion and 13 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 14 May 2026. 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?
Principal criteria of assessment is pain intensity three months after injection. (time frame: at 3 month). 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 NCT00437762, which also lists 2 linked publications.
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 14 May 2026.