Advertisement

 

 

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.

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.
Author Information (click to view)

Cogné M, Petit H, Creuzé A, Liguoro D, de Seze M,


Cogné M, Petit H, Creuzé A, Liguoro D, de Seze M, (click to view)

Cogné M, Petit H, Creuzé A, Liguoro D, de Seze M,

Advertisement

BMC musculoskeletal disorders 2017 11 1518(1) 454 doi 10.1186/s12891-017-1816-6
Abstract
BACKGROUND
Treatment for patients with chronic low-back pain (LBP) is a public health issue. Intramuscular injections of botulinum toxin A (BoNT-A) have shown an analgesic effect on LBP in two previous randomized controlled studies. The objective of the study was to verify the efficacy of paravertebral injections of BoNT-A in patients with LBP.

METHODS
Patients were included in this phase 3 randomized double-blinded trial comparing the efficacy of BoNT-A versus placebo in a crossover study on LBP. Both groups received 200 units of BoNT-A in paravertebral muscles or a placebo, and vice versa at Day 120. The main judgment criterion was LBP intensity 1 month after the injections, evaluated by using a visual pain scale (VAS). Secondary assessment criteria included: LBP intensity 90 and 120 days after injection day; number of days when an allowed antalgic oral treatment was needed in between each evaluation; functional disability measured by the Quebec Back Pain Disability Scale; quality of life; inability to work; patient satisfaction in relation to the treatment’s effect; spinal mobility; and strength of spinal muscles, measured by isokinetic technique.

RESULTS
Nineteen patients completed the study. There was no significant difference between the groups’ average LBP during the last 8 days at Day30 (p = 0.97). There was no significant difference between the two groups regarding the secondary assessment criteria (p > 0.05).

CONCLUSIONS
Injections of BoNT-A in the paravertebral muscles were not found to be effective to relieve chronic LBP. The limits of the study are that the dose of BoNT-A used was lower than in other studies, and that the limited number of patients included may explain the negative results.

TRIAL REGISTRATIONS
Identifiers: NCT03181802 . Unique Protocol ID: CHUBX2003.

Submit a Comment

Your email address will not be published. Required fields are marked *

seventeen + 2 =

[ HIDE/SHOW ]