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 (MYOTOX)

This study is currently recruiting participants. (see Contacts and Locations)
Verified October 2013 by Nantes University Hospital
Sponsor:
Information provided by (Responsible Party):
Nantes University Hospital
ClinicalTrials.gov Identifier:
NCT01967524
First received: October 18, 2013
Last updated: NA
Last verified: October 2013
History: No changes posted
  Purpose

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.


Condition Intervention Phase
Myofascial Pelviperineal Pain
Drug: botulinum toxin A + ropivacaïne
Drug: Ropivacaïne
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Nantes University Hospital:

Primary Outcome Measures:
  • Evolution of the PGI-I (Patient Global Impression of Improvement) [ Time Frame: 2 month ] [ Designated as safety issue: No ]

    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.



Secondary Outcome Measures:
  • Evaluation of pain on digital scale (EN) [ Time Frame: 6 month ]
    Evaluation of pain on digital scale (EN), each month after the injection

  • 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 ] [ Designated as safety issue: No ]
  • To assess the evolution of analgesics consumption (score MQS) [ Time Frame: 6 month ]

Estimated Enrollment: 80
Study Start Date: September 2013
Estimated Study Completion Date: April 2016
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: botulinum toxin A + ropivacaïne Drug: botulinum toxin A + ropivacaïne

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).

Active Comparator: Ropivacaïne Drug: Ropivacaïne

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).


  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01967524

Contacts
Contact: Jean-Jacques LABAT, Dr 02 40 08 39 12

Locations
France
Clinique Axium Not yet recruiting
Aix-en-Provence, France, 13097
Contact: Eric BAUTRANT, Dr         
Principal Investigator: Eric BAUTRANT, Dr         
Besançon University Hospital Not yet recruiting
Besançon, France, 25030
Contact: Fabrice MICHEL, Dr         
Principal Investigator: Fabrice MICHEL, Dr         
Clermont-Ferrand University Hospital Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Benoit RABISCHONG, Dr         
Principal Investigator: Benoit RABISCHONG, Dr         
Nantes University Hospital Recruiting
Nantes, France, 44093
Contact: Jean-Jacques , LABAT    02 40 08 39 12      
Principal Investigator: Jean-Jacques LABAT, Dr         
Centre Catherine de Sienne Not yet recruiting
Nantes, France, 44200
Contact: Thibault RIANT, Dr    02 28 27 23 15      
Principal Investigator: Thibault RIANT, Dr         
Nimes University Hospital Not yet recruiting
Nimes, France, 30029
Contact: Brigitte FATTON, Dr         
Principal Investigator: Brigitte FATTON, Dr         
Hôpital Rothschild Not yet recruiting
Paris, France, 75571
Contact: Anne LASSAUX, Dr         
Principal Investigator: Anne LASSAUX, Dr         
Rennes University Hospital Not yet recruiting
Rennes, France, 35033
Contact: Laurent SIPROUDHIS, Pr         
Principal Investigator: Laurent SIPROUDHIS, Pr         
La Réunion University Hospital Not yet recruiting
Saint Denis de la Réunion, France, 97405
Contact: Julie EGGERMONT, Dr         
Principal Investigator: Julie EGGERMONT, Dr         
Sponsors and Collaborators
Nantes University Hospital
Investigators
Principal Investigator: Jean-Jacques LABAT, Dr Nantes University Hospital
  More Information

No publications provided

Responsible Party: Nantes University Hospital
ClinicalTrials.gov Identifier: NCT01967524     History of Changes
Other Study ID Numbers: RC13_0061
Study First Received: October 18, 2013
Last Updated: October 18, 2013
Health Authority: France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by Nantes University Hospital:
Myofascial pain
Perineal pain
Chronic pelvic pain
Botulinum toxin type A
Ropivacaïne

Additional relevant MeSH terms:
Botulinum Toxins
Botulinum Toxins, Type A
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses
Anti-Dyskinesia Agents
Neuromuscular Agents

ClinicalTrials.gov processed this record on September 18, 2014