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

Sponsor

Nantes University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT01331356

Collaborator

(none)

Enrollment

Locations

Arm

Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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

Study Type:

Interventional

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 :

Oct 1, 2010

Actual Primary Completion Date :

Jul 1, 2012

Actual Study Completion Date :

Jul 1, 2012

Arms and Interventions

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

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

Primary Outcome Measures

Change from baseline in main score (SP) at 1 month [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

To assess the adverse events [6 month]
To assess the duration of action of the product (main score SP) [6 month]
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 [6 month]
To assess the evolution of analgesics consumption [6 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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