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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)

Primary Purpose

Chronic Low-back Pain

Status
Completed
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
Botox
Placebos
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low-back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Bordeaux University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

botulinum toxin A

Placebo

Arm Description

Outcomes

Primary Outcome Measures

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?"

Secondary Outcome Measures

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
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?"
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?"

Full Information

First Posted
May 29, 2017
Last Updated
June 8, 2017
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT03181802
Brief Title
Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain (LBP)?
Acronym
BoNT-A
Official Title
Are Paraspinous Intramuscular Injections of Botulinum Toxin A (BoNT-A) Efficient in the Treatment of Chronic Low-back Pain?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2017
Overall Recruitment Status
Completed
Study Start Date
November 18, 2003 (Actual)
Primary Completion Date
May 5, 2005 (Actual)
Study Completion Date
May 8, 2005 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low-back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
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
ParticipantInvestigator
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
botulinum toxin A
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Botox
Intervention Description
single injection of 200 International Unit of BoNT-A in 10 bilateral paravertebral intramuscular points for treating chronic LBP
Intervention Type
Drug
Intervention Name(s)
Placebos
Intervention Description
4 ml of physiological serum injected intramuscularly into the lumbar paravertebral muscles.
Primary Outcome Measure Information:
Title
effect of paravertebral injections of BoNT-A, 30 days after its administration in chronic LBP sufferers.
Description
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 Outcome Measure Information:
Title
Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.
Description
Initial pain was detailed as follows: Immediate average LBP was recorded on VAS at the first injection
Time Frame
Day 90
Title
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.
Description
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
Title
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.
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Matthieu DE SEZE
Organizational Affiliation
University Hospital, Bordeaux
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bordeaux University Hospital
City
Bordeaux
ZIP/Postal Code
33000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Foster et al., 2001 and Machado et al., 2016
Results Reference
background
PubMed Identifier
29141611
Citation
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.
Results Reference
derived
Links:
URL
http://www.cebm.net/wp-content/uploads/2014/06/CEBM-Levels-of-Evidence-2.1.pdf
Description
Oxford Centre for Evidence-Based Medicine 2011 Levels of Evidence

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

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