Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia
CompletedPhase 2NCT01331356
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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)
Study details
- Official title
- Prospective Multicenter Pilot Study Evaluating the Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia According to the Criteria of Rome III
- Conditions
- Proctalgia
- Interventions
- Sponsor
- Nantes University Hospital
- Start date
- 2010-10
- Primary completion
- 2012-07
- Sex
- All
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- France
- Total sites listed
- 2
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01331356