Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With… (NCT01331356) | Clinical Trial Compass
CompletedPhase 2
Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
France18 participantsStarted 2010-10
Plain-language summary
The main objective is to evaluate the analgesic efficacy of botulinum toxin type A in refractory chronic proctalgia one month after a bilateral injection of 50 units of Botox ® in the ganglion Impar (total dose = 100 units)
Who can participate
Age range18 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age \> 18 years
* Patient with chronic proctalgia according to the criteria of Rome III
* Chronic or recurrent rectal pain
* Pains evolve over periods of at least 20 minutes
* With the exclusion of other causes of rectal pain: ischemic, inflammatory bowel disease, cryptic lesions, intramuscular abscess, anal fissure, hemorrhoids, prostatitis and isolated coccydynia
* Pains evolve in a regular way since more than 3 months and the symptoms started since at least 6 months
* These chronic proctalgia include syndromes of anus elevator and nonspecific functional anorectal pains
* Patient with positive anesthetic block of ganglion Impar (minimum of 30 days before D0 and maximum of 270 days before D0)
* Main score (SP) ≥ 4 before infiltration of botulinum toxin type A
* Signed informed consent
* Subjects affiliated with an appropriate social security system
Exclusion Criteria:
* Pain related malignancy
* Patients with bleeding risk and recent anticoagulant therapy
* Surgery within 3 months
* Pre-existing anal incontinence
* Intolerance of botulinum toxin A, local anesthetics and radio contrast medium
* 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
What they're measuring
1
Change from baseline in main score (SP) at 1 month