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 Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
18
One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia
Nantes University Hospital
Nantes, France
Centre Catherine de Sienne
Nantes, France
Change from baseline in main score (SP) at 1 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).
Time frame: one month
To assess the adverse events
Time frame: 6 month
To assess the duration of action of the product (main score SP)
Time frame: 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
Time frame: 6 month
To assess the evolution of analgesics consumption
Time frame: 6 month
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