Homeopathy for chronic nonspecific low back pain

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) - BIOVERT (Bioactive Vertebra)

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000051957

Enrollment

120

Registered

2023-08-30

Start date

2023-08-22

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic nonspecific low back pain

Interventions

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 solut

Eligibility

Sex/Gender

All

Inclusion criteria

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%.

Exclusion criteria

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).

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

South America

Contacts

Public ContactUbiratan Adler

Sao Carlos Federal University Department of Medicine

ubiratanadler@ufscar.br00551633518340

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026