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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 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2016-12-15

No results posted yet for this study

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

Interventions

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).

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).

Sponsors & Collaborators

  • Nantes University Hospital

    lead OTHER

Principal Investigators

  • Jean-Jacques LABAT, Dr · Nantes University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-09-30
Primary Completion
2016-08-31
Completion
2016-08-31

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01967524 on ClinicalTrials.gov