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CompletedNCT03181802BoNT-AUpdated Jun 9, 2017

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

A Phase 3 interventional study of Botox and Placebos in Chronic Low-back Pain, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-06-09.

Sponsored by University Hospital, Bordeaux · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Registered 13 years 6 months after the study started (first participant enrolled Nov 2003, registered May 2017).
Phase
Phase 3
Study type
Interventional
Enrollment
19
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Chronic Low-back Pain
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In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 19 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 783 studies on the registry; 188 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
19 participants (actual)

Study arms

  • Experimental
    botulinum toxin A

    Drug: Botox

  • Placebo comparator
    Placebo

    Drug: Placebos

Interventions

  • DrugBotox

    single injection of 200 International Unit of BoNT-A in 10 bilateral paravertebral intramuscular points for treating chronic LBP

  • DrugPlacebos

    4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.

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What researchers measure

Primary outcomes

  1. 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?"

    Time frame: Day 30

Secondary outcomes

  1. 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

    Time frame: Day 90

  2. 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?"

    Time frame: Day 30

  3. 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?"

    Time frame: Day 120

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Study locations

1 site
  • Bordeaux University Hospital
    Bordeaux, 33000, France
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References and documents

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. PubMed 29141611 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 9, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03181802
Lead sponsor
University Hospital, Bordeaux
Responsible party
Sponsor
First posted
Jun 9, 2017
Start date
Nov 18, 2003
Primary completion
May 5, 2005
Completion
May 8, 2005
Last update
Jun 9, 2017

Study contacts

Matthieu DE SEZE
principal investigator · University Hospital, Bordeaux

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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