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Low Back Pain, RecurrentSCENAR/MWRNCT05223946

Treatment and Companion Diagnostics of Lower Back Pain Using SCENAR and Passive Medical Radiometry (MWR)

A study testing Microwave Radiometry, SCENAR-CHENS-01 and Traditional Combination Therapy in people with Low Back Pain, Recurrent, run by Kyrgyz State Medical Academy at 2 sites in Kyrgyzstan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Evaluation of the effectiveness of treatment of nonspecific pain in the lower back (LBP) is currently largely based on the patient's subjective feelings. The purpose of this study was to use passive medical radiometry (MWR) as a tool for assessing the effectiveness of various treatment methods in patients with acute… Read more about this study

Who is it for?
Any age
Conditions the study is for
Low Back Pain, Recurrent
What is being tested?
Microwave Radiometry, SCENAR-CHENS-01 and Traditional Combination Therapy
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
55 participants
Where
2 sitesKyrgyzstan
Study dates
1 Sep 2020to 4 Aug 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • acute and subacute LBP of the musculoskeletal,
  • nociceptive (with the duration of the current exacerbation up to 3 months inclusive),
  • nonspecific character, caused by various degenerative-dystrophic lesions of the spine or paravertebral tissues (without specifying the source of pain) who were in outpatient or inpatient departments

Who cannot join

  • presence of radiculopathy and myelopathy,
  • known congenital anomalies of the spine,
  • ankylosing spondylitis,
  • reactive arthritis,
  • rheumatoid arthritis,
  • suspicion of a secondary nature of pain,
  • gross cardiac arrhythmias, and probable neuropathic pain

Trial locations and contacts

2 sites in 1 country.

Kyrgyzstan2 sites
  • Educational - clinical - scientific medical center of KSMA

    Bishkek, Chui, 720020

  • Batyr Osmonov

    Bishkek, 720000

Other trials in Kyrgyzstan

About this study

Evaluation of the effectiveness of treatment of nonspecific pain in the lower back (LBP) is currently largely based on the patient's subjective feelings. The purpose of this study was to use passive medical radiometry (MWR) as a tool for assessing the effectiveness of various treatment methods in patients with acute and subacute nonspecific LBP. Patients with pain assessment on a visual analogue scale (VAS) from 6 to 10 points were divided into 2 groups: Group I included patients with pharmacological, syndrome-oriented treatment (n = 30, age 54.9 ± 2.3 years); Group II is a combination pharmacotherapy with self-controlled energy-neuro-adaptive regulation (SCENAR) (n = 25, age 52.8 ± 2.5 years). The investigators will compare that the addition of SCENAR therapy (Group II) will be able to potentiate the analgesic effect of the treatment using VAS. the investigators will confirm that the thermal asymmetry visualization allows to identify the area of pathological muscle spasm and/or inflammation in the projection of the vertebral-motor segment.

Read the detailed description

According to the Global Burden of Disease Study (2015), low back pain (LBP) has been one of the five leading causes of disability over the past 30 years. Indirect costs of unfulfilled work and social benefits are several times higher than the costs of actual treatment. In the "internal" structure of the LBP, nonspecific or musculoskeletal pain accounts for up to 80-90% of cases. LBP is characterized by a significant prevalence, high material costs for rehabilitation, and a large polymorphism of clinical manifestations. The number of treatment and diagnostic methods with a well-founded evidence base was very small. The main assessment of the effectiveness of therapy in most cases is based on the patient's subjective feelings and data from various questionnaires and scales. Subjunctivization of therapy evaluation leads to the underestimation of many treatment methods, which are questioned from the standpoint of evidence-based medicine. With this type of back pain, during clinical examination, radiography and MRI are inappropriate because of the lack of correlation between the severity of degenerative changes in the spine and the clinical picture.

It is the presence of pain that causes people to suffer, reduces the quality of life, and therefore non-steroidal analgesic drugs remain the drugs of the "first level". However, participants simultaneously have, especially with uncontrolled use, side effects on the gastrointestinal tract, cardiovascular, genitourinary systems, and other organs and systems.

Non-drug therapy is an important curative factor. One of the positively proven additional methods of treatment for various pain syndromes is percutaneous (transcutaneous) electro neurostimulation (TENS). The Cochrane Review showed the efficacy of TENS for acute pain of various origins. A comparative analysis with placebo was given with recommendations to consider TENS as a method of treatment, prescribed alone or in combination with other therapies. The method was also effective in treating neck pain in patients with whiplash injury after car accidents.

In addition to the subjective methods of assessing various methods and diagnostics of LBP treatment, passive medical radiometry (MWR) was chosen. The method is based on measuring the intensity of its own electromagnetic radiation of the internal tissues of the body in the ultrahigh-frequency range. MWR is widely used worldwide for various pathological conditions. It is known that processes occurring in the tissues of the body, especially those associated with pain, are often accompanied by a universal pathophysiological reaction. One of the signs of inflammation is an increase in temperature, which is associated with metabolic, vascular, and/or regulatory processes. Stable temperature changes precede or accompany clinical and morphological manifestations of the pathological process. Therefore, with a high probability, MWR can be used for early diagnosis and objective monitoring of treatment effectiveness.

Goal To evaluate the effectiveness of SCENAR treatment and MWR of various therapeutic regimens in patients with acute and subacute nonspecific LBP.

Materials and methods

The study is being carried out at the "Problematic Scientific Laboratory of Physical Methods of Diagnosis and Treatment" of Rostov State Medical University. A clinical randomized, parallel, divided into two groups (group selection method, even or odd), controlled, prospective study of patients with LBP is carried out. The local independent ethical committee of Rostov State Medical University approved the study (protocol No. 10/19 of 05/30/2019), and informed consent was obtained from all patients.

The total duration of the disease in patients ranged from 2 to 20 years, and the current exacerbation ranged from 1 d to 3 months. Clinical and neurological examination of patients with LBP is performed according to a specially developed protocol. The protocol included personal data, anamnestic data (including the duration of the current exacerbation), concomitant diseases, objective data, neurological status (including possible symptoms of radiculopathy and myelopathy), and a questionnaire for diagnosing neuropathic pain (Douleur Neuropathique en 4 questions - DN4). The inclusion criteria included patients with acute and subacute LBP of the musculoskeletal, nociceptive (with the duration of the current exacerbation up to 3 months inclusive), nonspecific character, caused by various degenerative-dystrophic lesions of the spine or paravertebral tissues (without specifying the source of pain) who were in outpatient or inpatient departments. The exclusion criteria included the presence of radiculopathy and myelopathy, known congenital anomalies of the spine, ankylosing spondylitis, reactive arthritis, rheumatoid arthritis, suspicion of a secondary nature of pain, gross cardiac arrhythmias, and probable neuropathic pain. Before treatment, some patients undergo MRI of the spine without axial load to exclude other diseases of the lumbar spine.

Being tested
Microwave Radiometry, SCENAR-CHENS-01, Traditional Combination Therapy
Keywords
Lower Back Pain, passive medical radiometry (MWR), SCENAR
Medical subject headings
Low Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Microwave RadiometryDiagnostic test

    Also called MWR

    The MWR 2020 (former RTM-01-RES) device is a unique commercially available CE marked device. The device is already registered in Russia and Kyrgyzstan for diagnostics of different diseases. There were several works on identification of excess of microwave emission due to inflammatory, process, cancer and other disorders.

  • SCENAR-CHENS-01Device

    Percutaneous electroneurostimulation (TENS) using the Self Controlled Energy Neuro Adaptive Regulator SCENAR-CHENS-01 device (ZAO OKB RITM, Taganrog, Russia)

  • Traditional Combination TherapyCombination product

    ketoprofen, tolperisone, symptomatic slow-acting drugs in osteoarthritis - SYSADOA - (glucosamine + chondroitin sulfate )

Study groups in NCT05223946
Study groupRoleWhat they receive
Passive Microwave RadiometryActive comparatorDiagnostic Test: Passive Microwave Radiometry The MWR2020 (former RTM-01-RES) device is a unique commercially available CE marked device. The device is already registered in Russia and Kyrgyzstan for diagnostics of different diseases.
Receives: Diagnostic Test: Microwave Radiometry; Combination Product: Traditional Combination Therapy
SCENARExperimentalPercutaneous electroneurostimulation (TENS) using the Self Controlled Energy Neuro Adaptive Regulator SCENAR-CHENS-01 device (ZAO OKB RITM, Taganrog, Russia)
Receives: Diagnostic Test: Microwave Radiometry; Device: SCENAR-CHENS-01; Combination Product: Traditional Combination Therapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Visual Analog Score (VAS) for pain for participants with traditional pharmacotherapy with the Self Controlled Energy Neuro Adaptive Regulator SCENAR-CHENS-01 device and traditional pharmacotherapy only.

    Visual Analog Score for pain for Participants with TRADITIONAL treatment only (ketoprofen, tolperisone, symptomatic slow-acting drugs in osteoarthritis - SYSADOA - (glucosamine + chondroitin sulfate ) and COMBINED treatment (TRADITIONAL + SCENAR-CHENS-01) assessed using Visual Analog Score for pain.

    The Visual Analog Scale (VAS) is most commonly a straight 100-mm line, without demarcation, that has the words "no pain" at the left-most end and "worst pain imaginable" (or something similar) at the right-most end. The pain VAS is a unidimensional measure of pain intensity, which has been widely used in diverse adult populations.

    Measured: 30 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Feb 2022
  2. Study start1 Sep 2020
  3. Primary completion1 May 2021
  4. Study completion4 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Diagnosis
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
55 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05223946
Sponsor's protocol ID
1/13 24.01.2013
Acronym
SCENAR/MWR
Status last verified
Dec 2021
First submitted
17 Aug 2021
Last updated
4 Feb 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Lanas A, Boers M, Nuevo J. Gastrointestinal events in at-risk patients starting non-steroidal anti-inflammatory drugs (NSAIDs) for rheumatic diseases: the EVIDENCE study of European routine practice. Ann Rheum Dis. 2015 Apr;74(4):675-81. doi: 10.1136/annrheumdis-2013-204155. Epub 2013 Dec 18.

    PubMed 24351518
  • Johnson MI, Paley CA, Howe TE, Sluka KA. Transcutaneous electrical nerve stimulation for acute pain. Cochrane Database Syst Rev. 2015 Jun 15;2015(6):CD006142. doi: 10.1002/14651858.CD006142.pub3.

    PubMed 26075732
  • Goryanin I, Karbainov S, Shevelev O, Tarakanov A, Redpath K, Vesnin S, Ivanov Y. Passive microwave radiometry in biomedical studies. Drug Discov Today. 2020 Apr;25(4):757-763. doi: 10.1016/j.drudis.2020.01.016. Epub 2020 Jan 28.

    PubMed 32004473
  • Lee TH, Kim SJ, Lim SM. Prevalence of disc degeneration in asymptomatic korean subjects. Part 2 : cervical spine. J Korean Neurosurg Soc. 2013 Feb;53(2):89-95. doi: 10.3340/jkns.2013.53.2.89. Epub 2013 Feb 28.

    PubMed 23560172

Questions about this trial

What is this clinical trial studying?

A study testing Microwave Radiometry, SCENAR-CHENS-01 and Traditional Combination Therapy in people with Low Back Pain, Recurrent, run by Kyrgyz State Medical Academy at 2 sites in Kyrgyzstan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Kyrgyzstan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Visual Analog Score (VAS) for pain for participants with traditional pharmacotherapy with the Self Controlled Energy Neuro Adaptive Regulator SCENAR-CHENS-01 device and traditional pharmacotherapy only. (time frame: 30 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05223946, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.

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