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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional therapy back pain treatment | No Intervention | Participants randomized to сonventional therapy group will receive complex rehabilitation program including physical exercise, phonophoresis with hydrocortisone, lumbar region massage, acupuncture within 2 weeks. | |
| Conventional physiotherapy therapy back pain treatment + ReOxy-therapy | Active Comparator | Participants randomized to Active Comparator group will receive complex rehabilitation program and 10 ReOxy-therapy sessions within 2 weeks (5 sessions per week). |
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| Conventional physiotherapy therapy + Sham ReOxy-therapy | Placebo Comparator | Participants randomized to Placebo Comparator group will receive complex rehabilitation program and 10 sham ReOxy-therapy sessions within 2 weeks (5 sessions per week). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, end of the 2-nd week |
| Measure | Description | Time Frame |
|---|---|---|
| Back pain intensity | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HR recovery after the 6-minute walk test | HR recovery measured by sphygmomanometer after the 6-minute walk test | Baseline and end of the 2-nd week |
| SAD/DAD recovery after the 6-minute walk test | SAD/DAD recovery measured by sphygmomanometer after the 6-minute walk test |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nadezhda Lyamina, M.D. | Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, Dept. No. 9 | Moscow | Russia |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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Prospective analysis in a 3-arm, randomized single-blind and placebo controlled study
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| 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. |
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| Baseline and 1-month post randomization |
| Roland Disability Questionnaire (RDQ) | 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 | Baseline and 1-month post randomization |
| Lumbar Range of Motion | 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. | Baseline, end of the 2-nd week |
| Change of lower back flexibility | 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. | Baseline, end of the 2-nd week |
| 6 min-walking test distance | Change in walking distance in meters during a 6-min period over a corridor of 30m length | Baseline, end of the 2-nd week |
| Hospital Anxiety and Depression Scale, HADS | 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 | Baseline and 1-month post randomization |
| Bergen Insomnia Scale (BIS) | 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. | Baseline and 1-month post randomization |
| Baseline and end of the 2-nd week |
| D013568 |
| Pathological Conditions, Signs and Symptoms |