Back to resultsReOxy Therapy in the Rehabilitation of Chronic Low Back Pain Patients With Comorbidity
Primary Purpose
Low Back Pain
Status
Completed
Phase
Not Applicable
Locations
Russian Federation
Study Type
Interventional
Intervention
ReOxy
Sham ReOxy
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring low back pain, chronic lumbar back pain
Eligibility Criteria
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;
Sites / Locations
- Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, Dept. No. 9
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
No Intervention
Active Comparator
Placebo Comparator
Arm Label
Conventional therapy back pain treatment
Conventional physiotherapy therapy back pain treatment + ReOxy-therapy
Conventional physiotherapy therapy + Sham ReOxy-therapy
Arm Description
Participants randomized to сonventional therapy group will receive complex rehabilitation program including physical exercise, phonophoresis with hydrocortisone, lumbar region massage, acupuncture within 2 weeks.
Participants randomized to Active Comparator group will receive complex rehabilitation program and 10 ReOxy-therapy sessions within 2 weeks (5 sessions per week).
Participants randomized to Placebo Comparator group will receive complex rehabilitation program and 10 sham ReOxy-therapy sessions within 2 weeks (5 sessions per week).
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
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
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.
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.
6 min-walking test distance
Change in walking distance in meters during a 6-min period over a corridor of 30m length
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
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.
Full Information
NCT ID
NCT05053672
First Posted
August 26, 2021
Last Updated
July 22, 2022
Sponsor
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
1. Study Identification
Unique Protocol Identification Number
NCT05053672
Brief Title
ReOxy Therapy in the Rehabilitation of Chronic Low Back Pain Patients With Comorbidity
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
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2021 (Actual)
Primary Completion Date
April 15, 2022 (Actual)
Study Completion Date
April 20, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
low back pain, chronic lumbar back pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective analysis in a 3-arm, randomized single-blind and placebo controlled study
Masking
Participant
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Conventional therapy back pain treatment
Arm Type
No Intervention
Arm Description
Participants randomized to сonventional therapy group will receive complex rehabilitation program including physical exercise, phonophoresis with hydrocortisone, lumbar region massage, acupuncture within 2 weeks.
Arm Title
Conventional physiotherapy therapy back pain treatment + ReOxy-therapy
Arm Type
Active Comparator
Arm Description
Participants randomized to Active Comparator group will receive complex rehabilitation program and 10 ReOxy-therapy sessions within 2 weeks (5 sessions per week).
Arm Title
Conventional physiotherapy therapy + Sham ReOxy-therapy
Arm Type
Placebo Comparator
Arm Description
Participants randomized to Placebo Comparator group will receive complex rehabilitation program and 10 sham ReOxy-therapy sessions within 2 weeks (5 sessions per week).
Intervention Type
Device
Intervention Name(s)
ReOxy
Intervention Description
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).
Intervention Type
Device
Intervention Name(s)
Sham ReOxy
Intervention Description
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 Outcome Measure Information:
Title
Back pain intensity will be measured by the Visual Analog Scale
Description
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.
Time Frame
Baseline, end of the 2-nd week
Secondary Outcome Measure Information:
Title
Back pain intensity
Description
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.
Time Frame
Baseline and 1-month post randomization
Title
Roland Disability Questionnaire (RDQ)
Description
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
Time Frame
Baseline and 1-month post randomization
Title
Lumbar Range of Motion
Description
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.
Time Frame
Baseline, end of the 2-nd week
Title
Change of lower back flexibility
Description
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.
Time Frame
Baseline, end of the 2-nd week
Title
6 min-walking test distance
Description
Change in walking distance in meters during a 6-min period over a corridor of 30m length
Time Frame
Baseline, end of the 2-nd week
Title
Hospital Anxiety and Depression Scale, HADS
Description
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
Time Frame
Baseline and 1-month post randomization
Title
Bergen Insomnia Scale (BIS)
Description
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.
Time Frame
Baseline and 1-month post randomization
Other Pre-specified Outcome Measures:
Title
HR recovery after the 6-minute walk test
Description
HR recovery measured by sphygmomanometer after the 6-minute walk test
Time Frame
Baseline and end of the 2-nd week
Title
SAD/DAD recovery after the 6-minute walk test
Description
SAD/DAD recovery measured by sphygmomanometer after the 6-minute walk test
Time Frame
Baseline and end of the 2-nd week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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;
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadezhda Lyamina, M.D.
Organizational Affiliation
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, Dept. No. 9
City
Moscow
Country
Russian Federation
12. IPD Sharing Statement
Learn more about this trial
ReOxy Therapy in the Rehabilitation of Chronic Low Back Pain Patients With Comorbidity
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