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

PHASE3CompletedINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

September 30, 2013

Primary Completion Date

August 31, 2016

Study Completion Date

August 31, 2016

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)."

Trial Locations (6)

13097

Clinique Axium, Aix-en-Provence

25030

Besançon University Hospital, Besançon

35033

Rennes University Hospital, Rennes

44093

Nantes University Hospital, Nantes

63003

Clermont-Ferrand University Hospital, Clermont-Ferrand

97405

La Réunion University Hospital, Saint Denis de La Réunion

All Listed Sponsors
lead

Nantes University Hospital

OTHER

NCT01967524 - 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 | Biotech Hunter | Biotech Hunter