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Homeopathy 2024; 113(04): 231-238
DOI: 10.1055/s-0043-1778062
Original Research Article

Homeopathy for Chronic Non-specific Low Back Pain: Study Protocol for a Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (The BIOVERT Trial)

Ubiratan Cardinalli Adler
1   Department of Medicine, Federal University of São Carlos, São Carlos, SP, Brazil
,
Maristela Schiabel Adler
1   Department of Medicine, Federal University of São Carlos, São Carlos, SP, Brazil
,
Helen Nogueira Carrer
2   Department of Physiotherapy, Federal University of São Carlos, São Carlos, SP, Brazil
,
Deise Lilian Costa Dias
3   School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil
,
José Nelson Martins Diniz
3   School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil
,
Manoela Gomes Grossi
3   School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil
,
Neli Aparecida Martins Sugimoto
3   School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil
,
Edson Zangiacomi Martinez
4   Ribeirão Preto Medical School, University of São Paulo, São Carlos, SP, Brazil
› Author Affiliations Funding The Center for Biological and Health Sciences at São Carlos Federal University grants institutional approval for research activities and does not provide financial support. The principal investigator will personally bear the expenses associated with the study, excluding the cost of the study medication, which HN-Cristiano Pharmacy in São Paulo have generously provided. The medication used in the study is off-patent, and HN-Cristiano Pharmacy is not involved in the formulation of the study's design, its execution, or the dissemination of the research findings.
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Abstract

Background Chronic non-specific low back pain (CNSLBP) lacks identifiable anatomical pathology and effective pharmacological treatment. Alternative approaches in homeopathy, specifically clinical homeopathy, utilize ultra-diluted (potentized) biological products. In Brazil, standardized biotherapics from sheep tissues, particularly fifty-millesimal (LM) potencies of sheep Lumbar Vertebra, have shown promise in alleviating CNSLBP.

Objectives Our objective is to present the study protocol of a clinical trial that will assess the efficacy and safety of the biotherapic Lumbar Vertebra LM2 in the short-term management of CNSLBP and to estimate its therapeutic duration.

Methods A randomized, double-blind, crossover, placebo-controlled clinical trial spanning 8 weeks per participant was designed. Participants will include 120 individuals (aged 20 to 60 years) with clinically diagnosed CNSLBP by the study's physiotherapist. Exclusion criteria are radicular pain, signs of radiculopathy, specific lumbar spine disorders, pregnancy, or puerperium (up to 60 days after delivery). The medical intervention includes participants being randomly assigned to one of two treatment sequences: homeopathy–placebo or placebo–homeopathy. The treatments will consist of Lumbar Vertebra LM2 oral solution, topical cream, and indistinguishable placebos. Each treatment period will span 2 weeks, with a 4-week washout interval between them. Primary outcome is the assessment of changes in self-reported pain levels using the numeric rating scale (NRS) score, analyzed with a random effects model across both treatment periods. Secondary outcomes are assessment of changes in self-reported disability levels using the Oswestry Disability Index (ODI), analyzed with a random effects model across both treatment periods, and pain and disability variations, evaluated by the NRS score and ODI respectively, after the first and second treatment periods. Adverse events will be assessed at weeks 2 and 8. Pain medications will be used concomitantly. Adherence will be evaluated by the weight of medication returned/standard weight.

Discussion The BIOVERT (Bioactive Vertebra) trial protocol is designed to investigate a homeopathic strategy for short-term CNSLBP treatment. Favorable outcomes for homeopathy could prompt subsequent studies evaluating the long-term effectiveness of LM potencies of Lumbar Vertebra for CNSLBP.

Trial Registration UMIN Clinical Trials Registry – ID: UMIN000051957

Keywords

homeopathy - biotherapics - low back pain - clinical study

Supplementary Material



Publication History

Received: 28 August 2023

Accepted: 03 October 2023

Article published online:
20 March 2024

© 2024. Faculty of Homeopathy. This article is published by Thieme.

Georg Thieme Verlag KG
Rüdigerstraße 14, 70469 Stuttgart, Germany

 

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