Analgesic Effect of an Injection of Botulinum Toxin Type A in the Ganglion Impar in Patients With Chronic Proctalgia (Impartox)

Study Description

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Brief 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)

Condition or disease	Intervention/treatment	Phase
Proctalgia	Drug: Botox	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	18 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (Open Label)
Primary Purpose:	Treatment
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
Study Start Date :	October 2010
Actual Primary Completion Date :	July 2012
Actual Study Completion Date :	July 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Injection of botulinum toxin type A	Drug: Botox; One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia

Outcome Measures

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Primary Outcome Measures :

1. Change from baseline in main score (SP) at 1 month [ Time Frame: one month ]
   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) by calculating the main score (SP).

Secondary Outcome Measures :

1. To assess the adverse events [ Time Frame: 6 month ]
2. To assess the duration of action of the product (main score SP) [ Time Frame: 6 month ]
3. 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 score and Hospital Anxiety and Depression (HAD) score [ Time Frame: 6 month ]
4. To assess the evolution of analgesics consumption [ Time Frame: 6 month ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

France
Nantes University Hospital
Nantes, France, 44093
Centre Catherine de Sienne
Nantes, France, 44200

Sponsors and Collaborators

Nantes University Hospital

Investigators

Principal Investigator:	Jean-Jacques LABAT, Dr	Nantes University Hospital

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Nantes University Hospital
ClinicalTrials.gov Identifier:	NCT01331356 History of Changes
Other Study ID Numbers:	10/4-T
First Posted:	April 8, 2011
Last Update Posted:	October 7, 2013
Last Verified:	October 2013

Keywords provided by Nantes University Hospital:

Chronic proctalgia; Botulinum toxin type A; Ganglion Impar	Perineal pain; Pudendal neuralgia; Refractory chronic proctalgia

Additional relevant MeSH terms:

Ganglion Cysts; Cysts; Neoplasms; Mucinoses; Connective Tissue Diseases; Botulinum Toxins; Botulinum Toxins, Type A; onabotulinumtoxinA; abobotulinumtoxinA; Analgesics	Acetylcholine Release Inhibitors; Membrane Transport Modulators; Molecular Mechanisms of Pharmacological Action; Cholinergic Agents; Neurotransmitter Agents; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Neuromuscular Agents