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

Low Back Pain Clinical Trial

Official title:
The Respiratory Therapy Method Based on Short-term Intermittent Exposures Hypoxia and Hyperoxia (ReOxy Therapy) in the Rehabilitation of Chronic Low Back Pain Patients With Cardiac or Pulmonary Comorbidities: a Randomized Controlled Trial

Clinical Trial 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.

Clinical Trial Description

This is a randomized, single-blinded, placebo-controlled trial, with chronic non-specific low back pain with multiple chronic conditions. Comorbidity constitutes a serious challenge for rehabilitative medicine - significantly reduces the patients' quality of life and restoration of the working capacity. The objective of the present study will be to evaluate the effectiveness of the combined non-medicinal rehabilitation programe which include a course of ReOxy- therapy and conventional therapy back pain treatment. 90 patients will be randomly allocated to three treatment groups: experimental ("hypoxic group" - ReOxy therapy + conventional therapy back pain treatment), placebo ("sham hypoxic group"- sham- ReOxy therapy + conventional therapy back pain treatment) and control (only conventional therapy back pain treatment). The clinical outcomes will be obtained at the completion of treatment (2 weeks) and at 1 month after randomization. The statistical analysis will follow the intention-to-treat principles and the between-group differences will be calculated by using mixed linear models. The outcomes of interest are pain intensity, lumbar range of motion function, general physical and mental status. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05053672
Study type Interventional
Source Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Contact
Status Completed
Phase N/A
Start date June 1, 2021
Completion date April 20, 2022
View Details
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