Myofascial Pelviperineal PainPhase 3MYOTOXNCT01967524
Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain
A Phase 3 study testing botulinum toxin A + ropivacaïne and Ropivacaïne in people with Myofascial Pelviperineal Pain, run by Nantes University Hospital at 6 sites in France.
Trial summary
Myofascial pains are frequently found during the clinical examination of the patients presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology of this component of the pain characterized by triggerpoints found in the clinical examination, remains uncertain; its coverage contributes… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Myofascial Pelviperineal Pain
- What is being tested?
- botulinum toxin A + ropivacaïne and Ropivacaïne
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 6 sitesFrance
- Study dates
- Sep 2013to Aug 2016
- 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
- Age > 18 years
- Patient presenting a "dysfunctional" pain of the pelvis or the perineum (without lesional pathology justifying a specific treatment) by an endopelvic touch
- Pain evolving since at least 6 months and persisting in spite of the analgesic treatments and the physiotherapy
- Patient presenting to the clinical examination one or several active triggerpoints found on the internal obturating muscles and/or elevators of the anus, with a maximum of 10 triggerpoints on the whole body.
- Patient presenting an average of the maximal pains of the week before the inclusion superior or equal to 4 and inferior or equal to 9/10 (evaluation of the daily maximal pain on a digital scale from 0 to 10)
- Signed informed consent
- Subjects affiliated with an appropriate social security system
Who cannot join
- Patients with bleeding risk and anticoagulant therapy
- Intolerance of botulinum toxin A, ropivacaïne and nitrous oxide
- Injection of botulinum toxin in any place whatsoever in the previous 3 months
- Pregnancy and breast feeding
- Antibiotic treatment by aminoglycosides
- Recent anti-inflammatory treatment
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- Severe myasthenia
- Lambert-Eaton syndrome
- Patients with neurological disorders, dysphagia, food choking or inhalation pneumonia
- Beck score > 16
- Patients having an average of the maximal pains of the previous week lower than 4
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
France6 sites
Clinique Axium
Aix-en-Provence, 13097
Besançon University Hospital
Besançon, 25030
Clermont-Ferrand University Hospital
Clermont-Ferrand, 63003
Nantes University Hospital
Nantes, 44093
Rennes University Hospital
Rennes, 35033
La Réunion University Hospital
Saint Denis de La Réunion, 97405
About this study
Myofascial pains are frequently found during the clinical examination of the patients presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology of this component of the pain characterized by triggerpoints found in the clinical examination, remains uncertain; its coverage contributes to the improvement of the global pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent fibers) but are they superior to the injections of local anesthetics of triggerpoints? The literature remains poor on the subject, justifying this randomized double-blind protocol comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as long as the patient remains improved and maximum in 6 months.
- Conditions
- Myofascial Pelviperineal Pain
- Being tested
- botulinum toxin A + ropivacaïne, Ropivacaïne
- Keywords
- Myofascial pain, Perineal pain, Chronic pelvic pain, Botulinum toxin type A, Ropivacaïne
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
botulinum toxin A + ropivacaïneDrug
D0 :
- Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1)
- QDSA (Saint-Antoine pain questionnaire)
- QCD (Pain questionnaire)
- MPI (Multidimensional Pain Inventory)
- Beck scale
- HAD (Hospital Anxiety and Depression scale)
- SF36 (Short Form 36)
- injection of botulinum toxin A associated with ropivacaïne
D30, D90, D120 and D150 (phone call): Calcul of the average of EN
D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36).
RopivacaïneDrug
D0 :
- Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1)
- QDSA (Saint-Antoine pain questionnaire)
- QCD (Pain Questionnaire)
- MPI (Multidimensional Pain Inventory)
- Beck scale
- HAD (Hospital Anxiety and Depression scale)
- SF36 (Short Form 36)
- injection of ropivacaïne alone
D30, D90, D120 and D150 (phone call): Calcul of the average of EN
D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36).
| Study group | Role | What they receive |
|---|---|---|
| botulinum toxin A + ropivacaïne | Experimental | Not described Receives: Drug: botulinum toxin A + ropivacaïne |
| Ropivacaïne | Active comparator | Not described Receives: Drug: Ropivacaïne |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the PGI-I (Patient Global Impression of Improvement)
The main objective is to evaluate the efficacy of injection of botulinum toxin A associated with ropivacaïne versus ropivacaïne alone on the global suffering of chronic myofascial pelviperineal syndromes two month after the injection.
The success will be defined as an improvement of the PGI-I corresponding to the first 2 levels.
Measured: 2 month
Secondary outcomes (3)
Evaluation of pain on digital scale (EN)
Evaluation of pain on digital scale (EN), each month after the injection
Measured: 6 month
To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck and HAD score
Measured: 6 month
To assess the evolution of analgesics consumption (score MQS)
Measured: 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2013 (estimated)
- Study startSep 2013
- Primary completionAug 2016
- Study completionAug 2016
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 Myofascial Pelviperineal PainStudies of the same condition, open and under way.
- 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
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jean-Jacques LABAT, Dr, Principal investigator, Nantes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01967524
- Sponsor's protocol ID
- RC13_0061
- Acronym
- MYOTOX
- Status last verified
- Dec 2016
- First submitted
- 18 Oct 2013
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.
PubMed 31981833
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter Randomized Double-blind Study Evaluating the Effects of Botulinum Toxin A Associated With ropivacaïne Versus ropivacaïne Alone in the Treatment of the Myofascial Pelviperineal Pain
- ClinicalTrials.gov ID
- NCT01967524
- Acronym / sponsor ID
- MYOTOX / RC13_0061
- Conditions
- Myofascial Pelviperineal Pain
- Keywords
- Myofascial pain, Perineal pain, Chronic pelvic pain, Botulinum toxin type A, Ropivacaïne
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Aug 2016 (actual)
- Study completion
- Aug 2016 (actual)
- First posted
- 23 Oct 2013 (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.
Myofascial pains are frequently found during the clinical examination of the patients presenting a painful chronic syndrome of the pelvis or the perineum. If the physiopathology of this component of the pain characterized by triggerpoints found in the clinical examination, remains uncertain; its coverage contributes to the improvement of the global pain of the patient. The physiotherapy can be useful but when it is not useful, we proposed injections of triggerpoints by local anesthetics. The injections of botulinum toxin on these triggerpoints have a legitimacy (action on the muscular cramp and action on the afferent fibers) but are they superior to the injections of local anesthetics of triggerpoints? The literature remains poor on the subject, justifying this randomized double-blind protocol comparing the efficacy of the botulinum toxin associated with a local anesthetic versus local anesthetic alone with a main criterion of evaluation in 2 months and a monthly follow-up as long as the patient remains improved and maximum in 6 months.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| botulinum toxin A + ropivacaïne | Experimental | Drug: botulinum toxin A + ropivacaïne |
| Ropivacaïne | Active comparator | Drug: Ropivacaïne |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age > 18 years
- Patient presenting a "dysfunctional" pain of the pelvis or the perineum (without lesional pathology justifying a specific treatment) by an endopelvic touch
- Pain evolving since at least 6 months and persisting in spite of the analgesic treatments and the physiotherapy
- Patient presenting to the clinical examination one or several active triggerpoints found on the internal obturating muscles and/or elevators of the anus, with a maximum of 10 triggerpoints on the whole body.
- Patient presenting an average of the maximal pains of the week before the inclusion superior or equal to 4 and inferior or equal to 9/10 (evaluation of the daily maximal pain on a digital scale from 0 to 10)
Key exclusion criteria (11 listed)
- Patients with bleeding risk and anticoagulant therapy
- Intolerance of botulinum toxin A, ropivacaïne and nitrous oxide
- Injection of botulinum toxin in any place whatsoever in the previous 3 months
- Pregnancy and breast feeding
- Antibiotic treatment by aminoglycosides
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 + ropivacaïneD0 : * Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1) * QDSA (Saint-Antoine pain questionnaire) * QCD (Pain questionnaire) * MPI (Multidimensional Pain Inventory) * Beck scale * HAD (Hospital Anxiety and Depression scale) * SF36 (Short Form 36) * injection of botulinum toxin A associated with ropivacaïne D30, D90, D120 and D150 (phone call): Calcul of the average of EN D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36). | Drug | botulinum toxin A + ropivacaïne |
| RopivacaïneD0 : * Calcul of the average of EN (digital scale) (EN completed from D-8 to D-1) * QDSA (Saint-Antoine pain questionnaire) * QCD (Pain Questionnaire) * MPI (Multidimensional Pain Inventory) * Beck scale * HAD (Hospital Anxiety and Depression scale) * SF36 (Short Form 36) * injection of ropivacaïne alone D30, D90, D120 and D150 (phone call): Calcul of the average of EN D60 and D180 (on site visits): adverse events reporting, calcul of the average of EN, PGI-I (Patient Global Impression of Improvement), questionnaires (QDSA, QCD, MPI, treatment satisfaction, Beck scale, HAD and SF36). | Drug | Ropivacaïne |
Primary outcome
Evolution of the PGI-I (Patient Global Impression of Improvement)
Time frame: 2 month
The main objective is to evaluate the efficacy of injection of botulinum toxin A associated with ropivacaïne versus ropivacaïne alone on the global suffering of chronic myofascial pelviperineal syndromes two month after the injection. The success will be defined as an improvement of the PGI-I corresponding to the first 2 levels.
3 secondary outcomes
Evaluation of pain on digital scale (EN)
Time frame: 6 month
To assess the changing parameters of quality of life: global improvement score / treatment satisfaction assessed by digital scale, international pain scales (MPI, QDSA, QCD) / Beck and HAD score
Time frame: 6 month
To assess the evolution of analgesics consumption (score MQS)
Time frame: 6 month
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 Sep 2026.
- Results publication: PubMed 31981833Levesque A, Ploteau S, Michel F, Siproudhis L, Bautrant E, Eggermont J, Rabischong B, Volteau C, Perrouin-Verbe MA, Labat JJ. Botulinum toxin infiltrations versus local anaesthetic infiltrations in pelvic floor myofascial pain: Multicentre, randomized, double-blind study. Ann Phys Rehabil Med. 2021 Jan;64(1):101354. doi: 10.1016/j.rehab.2019.12.009. Epub 2020 Jan 22.
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.
Jean-Jacques LABAT, Dr principal investigator
Nantes University Hospital
6 sites 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 + ropivacaïne and Ropivacaïne in people with Myofascial Pelviperineal Pain, run by Nantes University Hospital at 6 sites 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 7 inclusion and 11 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 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
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?
Evolution of the PGI-I (Patient Global Impression of Improvement) (time frame: 2 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 NCT01967524, 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 14 Sep 2026.