42
Participants
Start Date
November 30, 2020
Primary Completion Date
September 30, 2027
Study Completion Date
December 31, 2027
Ozone
Ozone Group: Standard treatment + Ozone therapy (O3/O2) by rectal insufflation. O3/O2 concentration progressively increased from 10 to 30 μg/ml; 40 sessions in 16 weeks.
Oxygen
Control Group: Standard treatment + Oxygen (O2) by rectal insufflation. O3/O2 concentration = 0 μg/ml (only O2); 40 sessions in 16 weeks.
RECRUITING
Complejo Hospitalario Materno Insular, Las Palmas de Gran Canaria
RECRUITING
Hospital Universitario de Gran Canaria Dr. Negrín, Las Palmas de Gran Canaria
Servicio Canario de Salud
OTHER
Instituto de Salud Carlos III
OTHER_GOV
Red de Investigación en Servicios de Salud en Enfermedades Crónicas
OTHER
Fundación DISA, Spain
UNKNOWN
Fundación Española del Dolor (FED)
UNKNOWN
Bernardino Clavo, MD, PhD
OTHER