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

• Status: Completed
• Trial end date: 2005-05-08
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University Hospital, Bordeaux
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

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.