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

NCT05223946 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 55

Last updated 2022-02-04

No results posted yet for this study

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.

Conditions

  • Low Back Pain, Recurrent

Interventions

DIAGNOSTIC_TEST

Microwave Radiometry

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.

DEVICE

SCENAR-CHENS-01

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

COMBINATION_PRODUCT

Traditional Combination Therapy

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

Sponsors & Collaborators

  • Rostov State Medical University

    collaborator UNKNOWN

  • University of Edinburgh

    collaborator OTHER

  • Kyrgyz State Medical Academy

    lead OTHER

Principal Investigators

  • Igor Goryanin, PhD · MMWR LTD

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
SINGLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-09-01
Primary Completion
2021-05-01
Completion
2021-08-04

Countries

  • Kyrgyzstan

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05223946 on ClinicalTrials.gov