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

NCT ID: NCT01967524

Last Updated: 2016-12-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2016-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

botulinum toxin A + ropivacaïne

Group Type: EXPERIMENTAL

botulinum toxin A + ropivacaïne

Intervention Type: 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).

Ropivacaïne

Group Type: ACTIVE_COMPARATOR

Ropivacaïne

Intervention Type: 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).

Interventions

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).

Intervention Type: 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).

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Nantes University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Jean-Jacques LABAT, Dr

Role: PRINCIPAL_INVESTIGATOR

Nantes University Hospital

Locations

Clinique Axium

Aix-en-Provence, , France

Besançon University Hospital

Besançon, , France

Clermont-Ferrand University Hospital

Clermont-Ferrand, , France

Nantes University Hospital

Nantes, , France

Rennes University Hospital

Rennes, , France

La Réunion University Hospital

Saint Denis de La Réunion, , France

Countries

France

References

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.

Reference Type: DERIVED

PMID: 31981833 (View on PubMed)

Other Identifiers

RC13_0061

Identifier Type: -

Identifier Source: org_study_id