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Completed

NCT Number: NCT05053672

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

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

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

Moscow, Russia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Patient with non-specific chronic low back pain for at least 3 months;
  • A pain intensity of at least 5 points measured by 0 -10 points pain rating scale;
  • Co-morbidity - IHD and/or CHF and/or COPD and/or chronic bronchitis)
  • Willing and able to consent, complete all assessment and study procedures;

Exclusion criteria

  • Specific types of back pain (metastatic cancer or bone cancer or secondary cancers, vertebral fractures, spinal infection, active inflammatory disease);
  • Low back surgery within past 3 months;
  • Serious cardiovascular, cerebrovascular, neuromuscular and other systemic diseases or other diseases affecting physical activity;
  • Any significant systemic illness or medical condition that could affect safety or compliance with study;
  • Major active or chronic unstable psychiatric illness (e.g. depression, bipolar disorder, obsessive compulsive disorder, schizophrenia) within the previous year;
  • Tumour disease except being successfully treated and off treatment with >2 years. Tumour disease except being successfully treated and off treatment with >2 years.
  • Use of other investigational agents or interventions one month prior to entry and for the duration of the trial;

Treatment and study plan

ReOxy

Device

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).

Sham ReOxy

Device

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.

Primary outcomes

  1. Back pain intensity will be measured by the Visual Analog Scale

    Time frame: Baseline, end of the 2-nd week

    Visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. The VAS consists of a 10cm horizontal line with the words "no pain" and "worst pain" at the line's end. VAS is a reliable and valid tool to reliable and valid tool to measure pain intensity measure pain intensity.

Secondary outcomes

  1. Back pain intensity

    Time frame: Baseline and 1-month post randomization

    Back pain intensity will be measured by the Visual Analog Scale Visual analogue scale (VAS) is a simple and frequently used method for the assessment of variations in intensity of pain. The VAS consists of a 10cm horizontal line with the words "no pain" and "worst pain" at the line's end. VAS is a reliable and valid tool to reliable and valid tool to measure pain intensity measure pain intensity.

  2. Roland Disability Questionnaire (RDQ)

    Time frame: Baseline and 1-month post randomization

    The Roland-Morris Questionnaire is a self-administered disability measure in which greater levels of disability are reflected by higher numbers on a 24-point scale

  3. Lumbar Range of Motion

    Time frame: Baseline, end of the 2-nd week

    Will be evaluated through the finger-to-floor test. Participant try to reach the floor with his fingertip by bending forward in the same time knees are kept extended. The distance between fingertips and floor are measured in centimetres by examiner.

  4. Change of lower back flexibility

    Time frame: Baseline, end of the 2-nd week

    Will be evaluated through Schober test (positive/negative). The examiner places one finger 5cm below the mark pproximately at the level of L5 and another finger at about 10cm above this mark. The patient is then instructed to touch his toes. If the increase in distance between the two fingers on the patients spine is less than 5cm then this is indicative of a limitation of lumbar flexion.

  5. 6 min-walking test distance

    Time frame: Baseline, end of the 2-nd week

    Change in walking distance in meters during a 6-min period over a corridor of 30m length

  6. Hospital Anxiety and Depression Scale, HADS

    Time frame: Baseline and 1-month post randomization

    The Hospital Anxiety and Depression Scale (HADS) is a questionnaire, comprising fourteen questions. Each item on the questionnaire is scored from 0-3. The scale is devided into 2 parts: (1) anxiety (minimum score 0, maximum sore 21) and (2) depression (minimum score 0, maximum sore 21).

    Scoring : 0-7- normal, 8-10-borderling abnormal, 11-21-abnormal

  7. Bergen Insomnia Scale (BIS)

    Time frame: Baseline and 1-month post randomization

    The BIS comprises six items that assesses symptoms of insomnia based on the insomnia criteria found in the Diagnostic and Statistical Manual of Mental Disorders-IV-TR (American Psychiatric Association). Higher values indicate higher levels of insomnia severity.

Other outcomes

  1. HR recovery after the 6-minute walk test

    Time frame: Baseline and end of the 2-nd week

    HR recovery measured by sphygmomanometer after the 6-minute walk test

  2. SAD/DAD recovery after the 6-minute walk test

    Time frame: Baseline and end of the 2-nd week

    SAD/DAD recovery measured by sphygmomanometer after the 6-minute walk test

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study 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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Sep 22, 2021
Registry last updated
Jul 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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