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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 90
- Locations
- 1
- Primary Endpoint
- Back pain intensity will be measured by the Visual Analog Scale
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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;
Outcomes
Primary Outcomes
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
- Bergen Insomnia Scale (BIS)(Baseline and 1-month post randomization)
- Back pain intensity(Baseline and 1-month post randomization)
- Roland Disability Questionnaire (RDQ)(Baseline and 1-month post randomization)
- Lumbar Range of Motion(Baseline, end of the 2-nd week)
- Change of lower back flexibility(Baseline, end of the 2-nd week)
- 6 min-walking test distance(Baseline, end of the 2-nd week)
- Hospital Anxiety and Depression Scale, HADS(Baseline and 1-month post randomization)