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Completed

NCT Number: NCT01331356

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

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)

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Key information

Conditions

Proctalgia Nerve Compression Syndromes Nervous System Diseases Neuralgia Neurologic Manifestations Neuromuscular Diseases Pain Pathological Conditions, Signs and Symptoms Peripheral Nervous System Diseases Pudendal Neuralgia Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Centre Catherine de Sienne, Nantes, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Botox

Drug

One injection of botulinum toxin type A in the ganglion Impar in patients with chronic proctalgia

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nantes University Hospital

Other

Registry information

Official study 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

Acronym: Impartox

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 8, 2011
Registry last updated
Oct 7, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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