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).

Autor:	Adler UC; Department of Medicine, Federal University of São Carlos, São Carlos, SP, Brazil., Adler MS; Department of Medicine, Federal University of São Carlos, São Carlos, SP, Brazil., Carrer HN; Department of Physiotherapy, Federal University of São Carlos, São Carlos, SP, Brazil., Dias DLC; School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil., Diniz JNM; School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil., Grossi MG; School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil., Sugimoto NAM; School Health Unit, Federal University of São Carlos, São Carlos, SP, Brazil., Martinez EZ; Ribeirão Preto Medical School, University of São Paulo, São Carlos, SP, Brazil.
Jazyk:	angličtina
Zdroj:	Homeopathy : the journal of the Faculty of Homeopathy [Homeopathy] 2024 Nov; Vol. 113 (4), pp. 231-238. Date of Electronic Publication: 2024 Mar 20.
DOI:	10.1055/s-0043-1778062
Abstrakt:	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. Competing Interests: None declared. (Faculty of Homeopathy. This article is published by Thieme.)
Databáze:	MEDLINE
Externí odkaz:	Zobrazit plný text záznamu