drugset / Trial / NCT03181802
Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?
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 ↗
Publications
- Background Foster et al., 2001 and Machado et al., 2016
- Cogne M, Petit H, Creuze A, Liguoro D, de Seze M. Are paraspinous intramuscular injections of botulinum toxin a (BoNT-A) efficient in the treatment of chronic low-back pain? A randomised, double-blinded crossover trial. BMC Musculoskelet Disord. 2017 Nov 15;18(1):454. doi: 10.1186/s12891-017-1816-6.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Botulinum toxin type A | Protein / enzyme biologic | 200 iu | Intramuscular |