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

NCT05053672 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2022-07-25

No results posted yet for this study

Summary

The aim of this study is to assess the effect of the respiratory therapy method based on short-term intermittent exposures to hypoxia and hyperoxia (ReOxy therapy) on the pain intensity, restoration of the lumbar range of motion, physical capacity, disability, mental and vegetative status in Chronic Low Back Pain patients with Multiple Chronic Conditions.

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.

Sponsors & Collaborators

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

    lead OTHER

Principal Investigators

  • Nadezhda Lyamina, M.D. · Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-01
Primary Completion
2022-04-15
Completion
2022-04-20

Countries

  • Russia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05053672 on ClinicalTrials.gov