Therapeutic Effects Analysis of Pudendal Nerve Infiltrations After 3 Months, in Patients Suffering of Pudendal Neuralgia
NCT ID: NCT00851513
Last Updated: 2013-09-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
PHASE4
202 participants
INTERVENTIONAL
2008-11-30
2011-02-28
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
* neuropathic pains treatment
* specific kinesitherapy
* Alcock's canal and sacrospinal ligament infiltrations under scan
* with diagnostic block
* local steroids injections
* and surgical decompression of pudendal nerve with transrectal approach.
Only surgery was validated after a randomised protocol studying surgery versus abstention, performed and published by the CHU de Nantes. Many techniques have been proposed for realization of pudendal nerve infiltrations. The results of these infiltrations have never been published, and no randomised study had ever evaluated those results, even at short-run. Very few randomized studies have validated steroids infiltrations techniques in canal syndrome neuropathies.
The primary objective of the investigators phase IV trial is to evaluate the efficacy of three different types of pudendal nerve infiltrations in Alcock's canal and sacrospinal ligament:
* group A: only local anesthetic (control arm)
* group B: local anesthetics associated with local steroids
* group C: local anesthetics associated with local steroids and important volumes of physiological serum
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Group B
local anesthetics (lidocaine) associated with local steroids (depo-medrol)
Lidocaine
local anesthetics
Depmedrol
local steroids
Group C
local anesthetics (lidocaine) associated with local steroids (depomedrol) and important volumes of physiological serum
Lidocaine
local anesthetics
Depmedrol
local steroids
physiological serum
important volumes of physiological serum
Group A
only local anesthetic (lidocaine)
Lidocaine
local anesthetics
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Lidocaine
local anesthetics
Depmedrol
local steroids
physiological serum
important volumes of physiological serum
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Man or woman aged more than 18 years old
* Suffering from pudendal neuralgia since more than six months
* Without previous infiltration identical to the one proposed by the protocol
* Without previous surgery of pudendal nerve
* Without any hemorrhagic risk factor
* No contra-indication to Lidocaïne, Depo-medrol or contrast-product injections
* Pain intensity with an average \> or = 40/100 (measured by scales during the fifteen days before infiltration)
Exclusion Criteria
* Patient who has filled his "pain note book" during less than 5 days over the 15 days before the infiltration
* Pregnancy
* Depression (Beck scale \> 16/39)
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Nantes University Hospital
OTHER
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jean-Jacques LABAT
Role: PRINCIPAL_INVESTIGATOR
Nantes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CH de la Côte Basque
Bayonne, , France
Centre MARIENIA
Cambo-les-Bains, , France
CHU Clermont-Ferrand
Clermont-Ferrand, , France
Hospices Civils de Lyon
Lyon, , France
CHU de Nantes
Nantes, , France
Catherine de Sienne
Nantes, , France
Hôpital Rothschild
Paris, , France
Scanner Saint Hilaire
Rouen, , France
Hôpital Charles Nicolle
Rouen, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BRD08/6-B
Identifier Type: -
Identifier Source: org_study_id