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

Mélanie Cogné, Hervé Petit, Alexandre Creuzé, Dominique Liguoro, Mathieu de Seze, Mélanie Cogné, Hervé Petit, Alexandre Creuzé, Dominique Liguoro, Mathieu de Seze

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.

Keywords: Botulinum toxin; Disability; Function; Low-back pain; Quality of life; Work.

Conflict of interest statement

Ethics approval and consent to participate

This trial obtained the approval of a French ethics Committee (2003/02) (Comité Sud-Ouest et Outre-mer III, consent obtained in February 2003) and all participants received an information note and gave their written informed consent.

Consent for publication

Not applicable

Competing interests

The authors declare that they have no competing interests.

Publisher’s Note

Springer Nature remains neutral with regard to jurisdictional claims in published maps and institutional affiliations.

Figures

Fig. 1
Fig. 1
Flow diagram
Fig. 2
Fig. 2
Pain intensity at D0,30, 90 and 120 for patients treated by Botulinum toxin A (BoNT-A) (group A) or by placebo (group B). Pain intensity was measured on a horizontal visual analogue scale 100 mm long, with « no pain » written on one end and « maximum pain » on the other. The question asked was: “How was the intensity of your low-back pain over the last 8 days?”
Fig. 3
Fig. 3
Quebec Back Pain Disability Scale at D0, 30, 90 and 120 for patients treated by Botulinum toxin A (group A) or by placebo (group B)
Fig. 4
Fig. 4
Estimated impact of low-back pain on quality of life at D0, D30, D90 and D120 for patients treated by Botulinum toxin A (group A) or by placebo (group B). It was measured on a horizontal visual analogue scale 100 mm long. The question asked was: "in your opinion, how was your quality of life over the last month?" (0 = no impact to 100 = major deterioration)

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