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

NCT01967524 | Completed Phase 3 DMC

• 1 other identifier: RC13_0061
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 6

Brief 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 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

Keywords

Myofascial pain; Perineal pain; Chronic pelvic pain; Botulinum toxin type A; Ropivacaïne

Outcome Measures

Primary Outcomes (1)

• 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.

  2 month

Secondary Outcomes (3)

• Evaluation of pain on digital scale (EN)

  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

  6 month

• To assess the evolution of analgesics consumption (score MQS)

  6 month

Study Arms (2)

botulinum toxin A + ropivacaïne

EXPERIMENTAL

Drug: botulinum toxin A + ropivacaïne

Ropivacaïne

ACTIVE COMPARATOR

Drug: Ropivacaïne

Interventions

botulinum toxin A + ropivacaïne DRUG

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).

botulinum toxin A + ropivacaïne

Ropivacaïne DRUG

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).

Ropivacaïne

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• Signed informed consent
• Subjects affiliated with an appropriate social security system

You may not qualify if:

• 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

Sponsors & Collaborators

• Nantes University Hospital: lead

Study Sites (6)

Clinique Axium

Aix-en-Provence, 13097, France

Location

Besançon University Hospital

Besançon, 25030, France

Location

Clermont-Ferrand University Hospital

Clermont-Ferrand, 63003, France

Location

Nantes University Hospital

Nantes, 44093, France

Location

Rennes University Hospital

Rennes, 35033, France

Location

La Réunion University Hospital

Saint Denis de La Réunion, 97405, France

Location

Related Publications (1)

• 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.

  PMID: 31981833 DERIVED

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Jean-Jacques LABAT, Dr

  Nantes University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 18, 2013
• First Posted: October 23, 2013
• Study Start: September 1, 2013
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: December 15, 2016

Record last verified: 2016-12

Locations

FR (6)