drugset / Trial / NCT03181802

Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?

NCT03181802 ↗

Phase 3 Completed 19 enrolled University Hospital, Bordeaux
RandomizedCrossoverDouble-blindTreatment

Summary

Studying the therapeutic effect of paravertebral injections of BoNT-A (botulinum toxin A) requires further studies to confirm the reported short-term therapeutic effect and to determine potential predictive factors of efficacy.

Timeline

Start
2003-11-18
Primary completion
2005-05-05
Completion
2005-05-08

Outcome

Missed primary endpoint

paper There was no significant difference between the groups' average LBP during the last 8 days at Day30 (p = 0.97). PMID 29141611 ↗

paper Injections of BoNT-A in the paravertebral muscles were not found to be effective to relieve chronic LBP. PMID 29141611 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Botulinum toxin type A Protein / enzyme biologic 200 iu Intramuscular

Indications