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

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ClinicalTrials.gov Identifier: NCT03181802
Recruitment Status : Completed
First Posted : June 9, 2017
Last Update Posted : June 9, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Chronic Low-back Pain Drug: Botox Drug: Placebos Phase 3

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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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 19 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: This study was a randomized, double-blinded, placebo-controlled phase 3 trial comparing Intramuscular injections of botulinum toxin A to a placebo in patients with chronic low-back pain (LBP)
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?
Actual Study Start Date : November 18, 2003
Actual Primary Completion Date : May 5, 2005
Actual Study Completion Date : May 8, 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain Botox

Arm Intervention/treatment
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

Placebo Comparator: Placebo Drug: Placebos
4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.




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

  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. [ Time Frame: Day 30 ]
    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?"

  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. [ Time Frame: 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?"



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03181802


Locations
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France
Bordeaux University Hospital
Bordeaux, France, 33000
Sponsors and Collaborators
University Hospital, Bordeaux
Investigators
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Principal Investigator: Matthieu DE SEZE University Hospital, Bordeaux
Additional Information:
Publications:
Foster et al., 2001 and Machado et al., 2016

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University Hospital, Bordeaux
ClinicalTrials.gov Identifier: NCT03181802    
Other Study ID Numbers: CHUBX2003
First Posted: June 9, 2017    Key Record Dates
Last Update Posted: June 9, 2017
Last Verified: May 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Signs and Symptoms