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

NCT05053672 | Completed

• 1 other identifier: 4 11052021
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain

Keywords

low back pain; chronic lumbar back pain

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (7)

• 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

Other Outcomes (2)

• HR recovery after the 6-minute walk test

  Baseline and end of the 2-nd week

• SAD/DAD recovery after the 6-minute walk test

  Baseline and end of the 2-nd week

Study Arms (3)

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).

Device: ReOxy

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).

Device: Sham ReOxy

Interventions

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).

Conventional physiotherapy therapy back pain treatment + ReOxy-therapy

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.

Conventional physiotherapy therapy + Sham ReOxy-therapy

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

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

Study Sites (1)

Moscow Scientific and Practical Center of Medical Rehabilitation, Restorative and Sports Medicine, Dept. No. 9

Moscow, Russia

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nadezhda Lyamina, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Prospective analysis in a 3-arm, randomized single-blind and placebo controlled study

Study Record Dates

• First Submitted: August 26, 2021
• First Posted: September 22, 2021
• Study Start: June 1, 2021
• Primary Completion: April 15, 2022
• Study Completion: April 20, 2022
• Last Updated: July 25, 2022

Record last verified: 2022-03

Locations

RU (1)