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

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

Status: Completed

Conditions: Low Back Pain

Treatments: Device: ReOxy; Device: Sham ReOxy

Study type: Interventional

Funder types: Other

Identifiers

NCT05053672

4 11052021

Details and patient eligibility

About

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.

Full 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.

Enrollment: 90 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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90 participants in 3 patient groups, including a placebo group

Conventional therapy back pain treatment

No Intervention group

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.

Conventional physiotherapy therapy back pain treatment + ReOxy-therapy

Active Comparator group

Description:

Participants randomized to Active Comparator group will receive complex rehabilitation program and 10 ReOxy-therapy sessions within 2 weeks (5 sessions per week).

Treatment:

Device: ReOxy

Conventional physiotherapy therapy + Sham ReOxy-therapy

Placebo Comparator group

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).

Treatment:

Device: Sham ReOxy