NCT05223946

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
55

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2020

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2020

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 4, 2021

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

August 17, 2021

Completed
6 months until next milestone

First Posted

Study publicly available on registry

February 4, 2022

Completed
Last Updated

February 4, 2022

Status Verified

December 1, 2021

Enrollment Period

8 months

First QC Date

August 17, 2021

Last Update Submit

January 24, 2022

Conditions

Low Back Pain, Recurrent

Keywords

Lower Back Painpassive medical radiometry (MWR)SCENAR

Outcome Measures

Primary Outcomes (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.

    30 days

Study Arms (2)

Passive Microwave Radiometry

ACTIVE COMPARATOR

Diagnostic 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.

Diagnostic Test: Microwave RadiometryCombination Product: Traditional Combination Therapy

SCENAR

EXPERIMENTAL

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

Diagnostic Test: Microwave RadiometryDevice: SCENAR-CHENS-01Combination Product: Traditional Combination Therapy

Interventions

Microwave RadiometryDIAGNOSTIC_TEST

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.

Also known as: MWR
Passive Microwave RadiometrySCENAR
SCENAR-CHENS-01DEVICE

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

SCENAR
Traditional Combination TherapyCOMBINATION_PRODUCT

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

Passive Microwave RadiometrySCENAR

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Educational - clinical - scientific medical center of KSMA

Bishkek, Chui, 720020, Kyrgyzstan

Location

Batyr Osmonov

Bishkek, 720000, Kyrgyzstan

Location

Related Publications (4)

  • 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.

    PMID: 24351518BACKGROUND

  • 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.

    PMID: 26075732BACKGROUND

  • 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.

    PMID: 32004473BACKGROUND

  • 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.

    PMID: 23560172RESULT

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Igor Goryanin, PhD

    MMWR LTD

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 17, 2021

First Posted

February 4, 2022

Study Start

September 1, 2020

Primary Completion

May 1, 2021

Study Completion

August 4, 2021

Last Updated

February 4, 2022

Record last verified: 2021-12

Locations

KY(2)