NCT03181802: BoNT-A

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

Completed Phase 3 Last updated 9 June 2017

What this trial tests

Phase 3 trial testing Botox in Chronic Low-back Pain in 19 participants. Completed in 8 May 2005.

Timeline

18 November 2003

Primary endpoint
5 May 2005

8 May 2005

Quick facts

Lead sponsor	University Hospital, Bordeaux
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	double
Primary purpose	treatment
Enrollment	19
Start date	18 November 2003
Primary completion	5 May 2005
Estimated completion	8 May 2005
Sites	1 location across France

Drugs / interventions tested

• Botox (ONABOTULINUMTOXINA) — full drug profile →
• Placebos — full drug profile →

Conditions studied

• Chronic Low-back Pain — all drugs for Chronic Low-back Pain →

Sponsor

University Hospital, Bordeaux

Who can join

18 and older, any sex, with Chronic Low-back Pain. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. 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.
   Cogné M, Petit H, Creuzé A, Liguoro D, et al · · 2017 · cited 6× · PMID 29141611 · DOI 10.1186/s12891-017-1816-6