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

Abstract

BackgroundTreatment 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.MethodsPatients 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.ResultsNineteen 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).ConclusionsInjections 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 registrationsIdentifiers: NCT03181802. Unique Protocol ID: CHUBX2003.

Efficacy, acceptability, and safety of muscle relaxants for adults with non-specific low back pain: systematic review and meta-analysis

“…Overall, 3362 records were identified, 215 duplicates removed, and 3147 records screened during title and abstract screening. Forty nine trials were included in the review: 35 were peer reviewed journal articles,46474849505152535455565758596061626364656667686970717273747576777879808182 two were conference abstracts,5774 and 12 were trial registry records838485868788899091929394 (fig 1 and supplementary file 8). Thirty one trials (two trial registry records and one conference abstract), including a total of 6505 participants, contributed data to the meta-analyses.…”

“…A total of 25 included trials were unsuitable for meta-analysis of the primary outcome pain intensity. Eight trial registry records8384858687919293 provided no data and 17 peer reviewed journal articles4849505660616365667071737479808182 did not provide data for relevant treatment effects. Supplementary file 10 provides full details of these trials.…”

“…Four trials50616581 concluded that miscellaneous muscle relaxants (ie, botulinum toxin) were superior to control for chronic low back pain, and one trial71 concluded that benzodiazepines were superior to control for pain intensity in the supine position but not while sitting.…”

Сучасні Аспекти Диференціальної Діагностики Й Лікування Хронічного Болю В Нижній Частині Спини

“…Зокрема, відповідно до даних окремих авторів, застосування абоботулотоксину А в лікуванні хронічного БНЧС сприяло вірогідному зменшенню болю й покращанню якості життя в пацієнтів порівняно з плацебо [68]. В іншому дослідженні ін'єкції ботулотоксину типу А в паравертебральні м'язи не виявилися ефективними для полегшення хронічного БНЧС, хоча негативний результат пов'язують з обмеженою кількістю включених пацієнтів і низькими дозами ботулотоксину [69]. Більш високі дози (> 200 одиниць на сеанс із 40-50 одиницями на одне місце введення) можуть зменшити інтенсивність БНЧС і покращити якість життя пацієнтів.…”

Botulinum toxin for chronic pain: What's on the horizon?

“…34 However, in randomized controlled double-blind studies comparing BoNT to placebo, local anesthetics, and steroids, there were no significant differences in pain scores. 35,36 The majority of studies have been landmark based or used the site of maximal tenderness as guidance for injections, but there is some evidence that targeted injections focusing on specific muscle groups may improve benefit. 5 This usually requires the use of imaging for guidance.…”