chronic idiopathic ano-perineal pain
Conditions
Brief summary
Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS) between inclusion and 1 month after the first injection.
Detailed description
Maintenance of positive response at 3 months, defined as a reduction of at least 3 VAS pain score points (compared with inclusion) 3 months after infiltration., Percentage of patients with a VAS score equal to 0 at 1 month after the first infiltration, Delta of the score on question 9 of the "modified" Concise Pain Questionnaire (CPQ) (French version of the Brief Pain Inventory) concerning the impact of pain, Delta of scores A (anxiety dimension) and D (depression dimension) on the HAD scale, Delta of the score for part A of the French version of the CSI central sensitization score
Interventions
DRUGLIDOCAINE AGUETTANT 10 mg/mL SANS CONSERVATEUR
DRUGSolution injectable
DRUG9 %
DRUGsolution injectable
Sponsors
Groupe Hospitalier Diaconesses Croix Saint Simon
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Comparison between the two treatment arms (lidocaine versus saline) of the rate of patients with a reduction of at least 3 points on a visual analog pain scale (VAS) between inclusion and 1 month after the first injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Maintenance of positive response at 3 months, defined as a reduction of at least 3 VAS pain score points (compared with inclusion) 3 months after infiltration., Percentage of patients with a VAS score equal to 0 at 1 month after the first infiltration, Delta of the score on question 9 of the "modified" Concise Pain Questionnaire (CPQ) (French version of the Brief Pain Inventory) concerning the impact of pain, Delta of scores A (anxiety dimension) and D (depression dimension) on the HAD scale, Delta of the score for part A of the French version of the CSI central sensitization score | — |
Countries
France
Outcome results
None listed