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

University Hospital of Bordeaux

Status and phase

Completed

Phase 3

Conditions

Chronic Low-back Pain

Treatments

Drug: Placebos

Drug: Botox

Study type

Interventional

Funder types

Other

Identifiers

NCT03181802

CHUBX2003

Details and patient eligibility

About

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.

Full 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.

Enrollment

19 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.