Completed

NCT Number: 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

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.

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Key information

Conditions

Myofascial Pelviperineal Pain

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Clinique Axium, Aix-en-Provence, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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

Primary outcomes

Evolution of the PGI-I (Patient Global Impression of Improvement)

Time frame: 2 month

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 outcomes

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
To assess the evolution of analgesics consumption (score MQS)

Time frame: 6 month

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Acronym: MYOTOX

Important dates

Study start: 2013
Primary completion: 2016
Study completion: 2016
First posted: Oct 23, 2013
Registry last updated: Dec 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.