UMIN-CTR Clinical Trial

Public title

Homeopathy for chronic nonspecific low back pain

Acronym

BIOVERT (Bioactive Vertebra)

Scientific Title

Homeopathy for chronic nonspecific low back pain: randomized, double-blind, crossover, placebo-controlled clinical trial investigating the efficacy of a lumbar vertebra biotherapic (BIOVERT trial)

Scientific Title:Acronym

BIOVERT (Bioactive Vertebra)

Region

South America

Condition

Chronic nonspecific low back pain

Classification by specialty

Medicine in general

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

To assess the efficacy and safety of biotherapic lumbar vertebra LM2 in the short-term management of nonspecific chronic low back pain and to estimate its therapeutic duration.

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Others

Trial characteristics_2

Explanatory

Developmental phase

Phase II

Primary outcomes

Assessment of changes in self-reported pain levels using the Numeric Rating Scale (NRS) score, analysed with a random effects model across both treatment periods.

Key secondary outcomes

Assessment of changes in self-reported disability levels using the Oswestry Disability Index, analysed with a random effects model across both treatment periods. Pain and disability variations, evaluated by the NRS score and Oswestry Disability Index, respectively, after the first and second treatment periods. Adverse events assessed at weeks 2 and 8. Concomitant use of pain medications. Adherence, evaluated by the weight of medication returned/standard weight.

Study type

Interventional

Basic design

Cross-over

Randomization

Randomized

Randomization unit

Individual

Blinding

Double blind -all involved are blinded

Control

Placebo

Stratification

NO

Dynamic allocation

NO

Institution consideration

Blocking

NO

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine

Interventions/Control_1

Homeopathy
Lumbar Vertebra LM2 oral solution: the participant must perform 10 succussions to the vial before each dose and administer 1 drop orally in the morning, afternoon, and evening of the solution derived from a globule of the dynamized biotherapic.
Lumbar Vertebra LM2 cream (30 g of base cream containing 10% of the same solution as above): the participant must apply and gently massage a thin layer of the cream onto the lumbar region before bedtime.
The clinical investigator can make dosage adjustments without unmasking, such as escalating the daily dosage to four times if initial response is not observed.

Interventions/Control_2

Placebo
30% hydroalcoholic solution: the participant must perform 10 succussions to the vial before each dose and administer 1 drop orally in the morning, afternoon, and evening.
Inert cream: the participant must apply and gently massage a thin layer of the cream (same base) onto the lumbar region before bedtime.

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

20

years-old

<=

Age-upper limit

60

years-old

>=

Gender

Male and Female

Key inclusion criteria

Women and men aged 20 to 60 years, clinically diagnosed with chronic non-specific low back pain by the study's physiotherapist, meeting all the following criteria:
Low back pain lasting at least three months and/or pain in at least half of the days in the past six months.
Pain localized between T12 and gluteal folds.
Pain intensity equal to or greater than three on a 10-unit Numeric Rating Scale (NRS); Oswestry Disability Index score higher than 14%.

Key exclusion criteria

Radicular pain or signs of radiculopathy and/or alerting clinical features indicating specific disorders of the lumbar spine, such as trauma, fever, malaise, night sweats, weight loss, history of cancer, HIV, chronic steroid use, injectable drug use, immunosuppression, relentless pain, urinary or fecal incontinence, saddle anesthesia, bilateral neurological symptoms, lower limb weakness; comorbidities that render the participant incapable of complying with study procedures; pregnancy, or puerperium (up to 60 days after delivery).

Target sample size

120

Name of lead principal investigator

1st name	Ubiratan
Middle name	Cardinalli
Last name	Adler

Organization

Universidade Federal de Sao Carlos (Sao Carlos Federal University) - Sao Carlos/SP/Brazil

Division name

Department of Medicine

Zip code

13565905

Address

Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil

TEL

00551633518340

Email

ubiratanadler@ufscar.br

Name of contact person

1st name	Ubiratan
Middle name	Cardinalli
Last name	Adler

Organization

Sao Carlos Federal University

Division name

Department of Medicine

Zip code

13565905

Address

Rodovia Washington Luiz, Km 235, Sao Carlos, SP, Brazil

TEL

00551633518340

Homepage URL

https://www.ufscar.br/a-ufscar

Email

ubiratanadler@ufscar.br

Institute

Center for Biological and Health Sciences/Sao Carlos Federal University

Institute

Department

Personal name

Organization

The researchers will fund the BIOVERT study. The Pharmacy HN-Cristiano of Sao Paulo kindly provided study medications and placebos.

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Brazilian

Co-sponsor

Name of secondary funder(s)

Organization

Universidade Federal de Sao Carlos (UFSCar) Human Research Ethics Committee

Address

Rodovia Washington Luis km 235 Sao Carlos/SP 13.565-905

Tel

00551633519685

Email

cephumanos@ufscar.br

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

08

Month

30

Day

URL releasing protocol

https://pubmed.ncbi.nlm.nih.gov/38508222/

Publication of results

Published

URL related to results and publications

https://pubmed.ncbi.nlm.nih.gov/42134335/

Number of participants that the trial has enrolled

120

Results

Both the biotherapic and placebo interventions produced significant within-group reductions in pain and disability (p = 0.001 and p < 0.001). However, no between-group differences were found for either outcome (pain: p = 0.435; disability: p = 0.840). Pain reduction did not reach the predefined MCID, and mean endpoint scores remained above the inclusion threshold. Adverse events were mild and similar across groups.

Results date posted

2026

Year

05

Month

16

Day

Results Delayed

Results Delay Reason

Date of the first journal publication of results

2025

Year

05

Month

15

Day

Baseline Characteristics

Participants in the study were generally comparable across both intervention sequences. The sample consisted of middle-aged adults with an average age of about 44 years. Women were slightly more represented than men, and most participants were classified as overweight or obese. Educational backgrounds varied, although most had completed secondary education or higher. Income levels were mostly in the lower to middle range (<= 2,250 USD per month). Most participants were employed or self-employed, and many reported spending long periods standing or sitting at work. Physical activity was infrequent, with more than half reporting that they did not exercise regularly. On average, lower back pain had been present for more than 10 years, and most had previously sought treatment, mainly with oral or injectable medications. About half had used medication in the week before enrollment, most commonly NSAIDs, analgesics, and muscle relaxants.

Participant flow

Detailed in Figure 1. https://pubmed.ncbi.nlm.nih.gov/42134335/

Adverse events

Fourteen participants in the biotherapic group and fifteen participants in the placebo group reported at least one adverse event during their respective treatment periods. Table 2 details the specific adverse events reported by these participants during the biotherapic and placebo treatment weeks, with 13 and 12 events in the biotherapic and placebo groups, respectively.

Outcome measures

Primary outcome
The primary outcome was the change in self-reported pain levels, measured using the Numerical Rating Scale (NRS) and analyzed with a random-effects model to account for repeated measures across both treatment periods. A significant reduction in mean NRS scores was observed after both interventions (biotherapic and placebo), with p = 0.001 for within-group comparisons. However, there was no statistically significant difference in pain reduction between the two interventions (p = 0.435). There was also no significant interaction between treatment sequence and outcome, indicating that the order in which participants received the interventions (biotherapic-placebo or placebo-biotherapic) did not influence the results (p = 0.968).

Plan to share IPD

IPD sharing Plan description

Recruitment status

Terminated

Date of protocol fixation

2023

Year

07

Month

30

Day

Date of IRB

2023

Year

07

Month

30

Day

Anticipated trial start date

2023

Year

08

Month

22

Day

Last follow-up date

2024

Year

10

Month

30

Day

Date of closure to data entry

2024

Year

11

Month

01

Day

Date trial data considered complete

Date analysis concluded

Other related information

February 26, 2024: we have included 59/60 participants, and the study protocol has been accepted for publication.
April 05, 2024: study protocol publication: https://pubmed.ncbi.nlm.nih.gov/38508222/
September 03, 2024: The last follow-up date has been anticipated to be September 30th.
February 20, 2025: all participants ended the study. Data analysis in progress.
September 26, 2025: manuscript submitted to publication.
March 10, 2026: manuscript accepted for publication:

Manuscript Number: HOMP-D-25-00157R1.
Title: Homeopathy for Chronic Non-specific Low Back Pain: Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (BIOVERT Trial).

January 08, 2026.

Dear Dr Adler,

Thank you for having submitted your carefully and thoroughly revised manuscript to Homeopathy.

I am pleased to inform you that I am now accepting your paper, "Homeopathy for Chronic Non-specific Low Back Pain: Randomized, Double-Blind, Crossover, Placebo-Controlled Clinical Trial Investigating the Efficacy of the Biotherapic Lumbar Vertebra (BIOVERT Trial)", for publication in the journal.

See below a list of required next steps that you should follow please to enable your accepted paper to move into production and to ultimate publication.

Thank you again for your submission.

With kind regards.

Yours sincerely,

Robert T. Mathie, PhD
Editor, Homeopathy.

Registered date

2023

Year

08

Month

21

Day

Last modified on

2026

Year

05

Month

16

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000059300