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

Phase 3

Completed

• Conditions: Chronic Low-back Pain
• Interventions: Drug: Placebos; Drug: Botox

• Registration Number: NCT03181802
• Lead Sponsor: University Hospital, Bordeaux

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.

Study Timeline

• Study Start: 2003-11-18
• Primary Completion: 2005-05-05
• Study Completion: 2005-05-08
• Status Verified: 2017-05
• Study First Submitted: 2017-05-29
• Study First Submitted QC: 2017-06-08
• Last Update Submitted: 2017-06-08
• Study First Posted: 2017-06-09
• Last Update Posted: 2017-06-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 19

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Placebo	Placebos	-
botulinum toxin A	Botox	-

Primary Outcome Measures

Name	Time	Method
effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.	Day 30	Pain intensity was measured on a horizontal visual analogue scale (VAS) 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 LBP over the last 8 days?"

Secondary Outcome Measures

Name	Time	Method
Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.	Day 90	Initial pain was detailed as follows: Immediate average LBP was recorded on VAS at the first injection
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.	Day 120	Lumbar 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 LBP over the last 8 days?" The question asked was: "How was the intensity of your LBP over the last 8 days?"

Trial Locations

Locations (1)

Bordeaux University Hospital; 🇫🇷 Bordeaux, France