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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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 Rom

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)

Detailed Summary:
Sponsor: Nantes University Hospital

Current Primary Outcome: 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).


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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 ]


Original Secondary Outcome:

  • 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 and HAD score [ Time Frame: 6 month ]
  • To assess the evolution of analgesics consumption [ Time Frame: 6 month ]


Information By: Nantes University Hospital

Dates:
Date Received: March 31, 2011
Date Started: October 2010
Date Completion:
Last Updated: October 4, 2013
Last Verified: October 2013