Clinical trial NCT05053672: 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
Overall status: COMPLETED
Phase: NA
Conditions: Low Back Pain
Keywords: low back pain
chronic lumbar back pain
Lead sponsor: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
Sponsor class: OTHER
First posted: 2021-09-22
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Prospective analysis in a 3-arm, randomized single-blind and placebo controlled study
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: Back pain intensity will be measured by the Visual Analog Scale
timeFrame: Baseline, end of the 2-nd week
Secondary outcomes:
measure: Back pain intensity
timeFrame: Baseline and 1-month post randomization
measure: Roland Disability Questionnaire (RDQ)
timeFrame: Baseline and 1-month post randomization
measure: Lumbar Range of Motion
timeFrame: Baseline, end of the 2-nd week
measure: Change of lower back flexibility
timeFrame: Baseline, end of the 2-nd week
measure: 6 min-walking test distance
timeFrame: Baseline, end of the 2-nd week
measure: Hospital Anxiety and Depression Scale, HADS
timeFrame: Baseline and 1-month post randomization
measure: Bergen Insomnia Scale (BIS)
timeFrame: Baseline and 1-month post randomization
Other outcomes:
measure: HR recovery after the 6-minute walk test
timeFrame: Baseline and end of the 2-nd week
measure: SAD/DAD recovery after the 6-minute walk test
timeFrame: Baseline and end of the 2-nd week
Locations:
city: Moscow
country: Russian Federation
facility: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, Dept. No. 9
Study officials:
affiliation: Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine
name: Nadezhda Lyamina, M.D.
role: PRINCIPAL_INVESTIGATOR
References: