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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Low-back Pain
• Intervention / Treatment: Drug: Botox; Drug: Placebos

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 Type: Interventional
• Enrollment (Actual): 19
• Phase: Phase 3

Contacts and Locations

Study Locations

• France
  • Bordeaux, France, 33000
    • Bordeaux University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Placebo	Drug: Placebos; 4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.
Experimental: botulinum toxin A	Drug: Botox; single injection of 200 International Unit of BoNT-A in 10 bilateral paravertebral intramuscular points for treating chronic LBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.	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?"	Day 30

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.	Initial pain was detailed as follows: Immediate average LBP was recorded on VAS at the first injection	Day 90
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.	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?"	Day 30
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.	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?"	Day 120

Collaborators and Investigators

• Sponsor: University Hospital, Bordeaux
• Investigators: Principal Investigator: Matthieu DE SEZE, University Hospital, Bordeaux

Publications and helpful links

General Publications

• Foster et al., 2001 and Machado et al., 2016
• 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.

Helpful Links

• Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2003
• Primary Completion (Actual): May 5, 2005
• Study Completion (Actual): May 8, 2005

Study Registration Dates

• First Submitted: May 29, 2017
• First Submitted That Met QC Criteria: June 8, 2017
• First Posted (Actual): June 9, 2017

Study Record Updates

• Last Update Posted (Actual): June 9, 2017
• Last Update Submitted That Met QC Criteria: June 8, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: CHUBX2003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No