ReOxy Therapy in the Rehabilitation of Chronic Low Back Pain Patients With Comorbidity
Condition: Low Back Pain
MeSH terms: Back Pain; Low Back Pain
Study type: Interventional

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.
    

Detailed 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.
    

Intervention name(s): ReOxy; Sham ReOxy
Intervention type(s): Device; Device
Intervention description(s): 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).; 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Prospective analysis in a 3-arm, randomized single-blind and placebo controlled study
Masking: Single (Participant)
Primary purpose: Treatment
Keywords: low back pain; chronic lumbar back pain