ReOxy Therapy in the Rehabilitation of Chronic Low Back Pain Patients With Comorbidity

NACompletedINTERVENTIONAL
Enrollment

90

Participants

Timeline

Start Date

June 1, 2021

Primary Completion Date

April 15, 2022

Study Completion Date

April 20, 2022

Conditions
Low Back Pain
Interventions
DEVICE

ReOxy

"ReOxy therapy is a protocol which employs passive (the patient is at rest), short (up to 10 min) mild normobaric hypoxic exposures alternated with similar duration intervals of breathing hyperoxia (up to 5 min). The gas mixtures are supplied to a patient via facial mask on continued measuring of oxygenation status of the patients, lasting about 45 min in total per treatment session.~The hypoxic load will be individually adjusted, based on the results of a preliminary hypoxic test. The patient inhales air with low oxygen content (10-14%) at atmospheric pressure in a continuous mode through a mask withing 10-min.~During the ReOxy - treatment session, the software automatically adjusts the gas mixture switching, based on changes in physiological parameters (blood oxygen saturation and heart rate) in response to hypoxic and hyperoxic impact (biofeedback control)."

DEVICE

Sham ReOxy

Placebo treatment with 'sham' ambient air breathing to simulate ReOxy-therapy sessions. Placebo-mode breathing set visually similar to standard breathing set but have a mask with open intake valve. The masks are chosen in a way to provide maximum degree of similarity to reduce the risk of unblinding on the patient-side.

Trial Locations (1)

Unknown

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, Dept. No. 9, Moscow

All Listed Sponsors
lead

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

OTHER