Clinical trial NCT03181802: Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?
Official title: Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Low-back Pain
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2017-06-09
Enrollment: 19
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing Intramuscular injections of botulinum toxin A to a placebo in patients with chronic low-back pain (LBP)
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing BoNT-A Type A injections to a placebo in patients with chronic Low-back Pain (LBP). This superiority trial obtained support from the French Hospital Clinical Research Project (PHRC) and the approval of a French ethics committee (2003/02) ("Comité Sud-Ouest et Outre-Mer III", consent obtained in February 2003).

The number of participants included in the study was chosen to be similar as those included in previous studies, that showed a strong positive effect of BoNT-A injections on LBP. Furthermore, the design of our study (i.e. a crossover) increased the power of the statistical analysis. A scientific committee has been solicited at this step, after including 19 patients, to assess the results.

Eligibility criteria: Inclusion Criteria:

* LBP defined as a pain located between the thoracic lumbar hinge and the gluteal sulcus, where pain had evolved over a period of 6 months despite well conducted medical treatment, self-assessed lumbar pain intensity over 50 millimeters long on a visual analogue scale of 100 millimeters (0=no pain; 100=maximal pain),
* having been on sick leave for 60 or more days in the year preceding the inclusion (in order to include patients with high consequences of chronic low-back pain on their work),
* same long-term chronic pain treatment for at least 6 weeks

Exclusion Criteria:

* age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),
* ongoing pregnancy or breast-feeding,
* a neuromuscular pathology (myasthenia gravis, amyotrophic lateral sclerosis, myopathy, polymyositis), aminoglycoside treatment at the time of inclusion,
* skin infection at injection points,
* diabetes and alcoholism (in order to avoid other etiologies of chronic pain),
* a history of injecting BoNT-A A,
* anticoagulation treatment, sciatica,
* suspected spinal inflammatory disorder (spondylitis, inflammatory rheumatism, tumoral pathology),
* a failed back surgery syndrome (when surgery failed to relieve low-back pain), - incapacity to stand, cardiorespiratory deficiency which does not allow the isokinetic exploration of the spinal muscles,
* cognitive disorders limiting patient participation,
* conflicts of interest owing to existing pain (unconsolidated work accident, ongoing damage compensation).
* Spine infection, tumour or trauma had been specifically excluded by an MRI done by all patients before the inclusion in the present study.
* No patient was allowed to take opiates during the time of the study,
* facet joint injections were also not permitted during the study period.

Primary outcomes:
measure: effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.
timeFrame: Day 30
Secondary outcomes:
measure: Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.
timeFrame: Day 90
measure: Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.
timeFrame: Day 30
measure: Measure the impact of paravertebral injections of 200 IU of BoNT-A in a single administration on lumbar stiffness and on spinal extensor muscle strength in patients with chronic LBP.
timeFrame: Day 120
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Bordeaux University Hospital
Study officials:
affiliation: University Hospital, Bordeaux
name: Matthieu DE SEZE
role: PRINCIPAL_INVESTIGATOR
References:
citation: Foster et al., 2001 and Machado et al., 2016
citation: 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.