NCT03181802

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
19

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Nov 2003

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 18, 2003

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 5, 2005

Completed
3 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 8, 2005

Completed
12.1 years until next milestone

First Submitted

Initial submission to the registry

May 29, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 9, 2017

Completed
Last Updated

June 9, 2017

Status Verified

May 1, 2017

Enrollment Period

1.5 years

First QC Date

May 29, 2017

Last Update Submit

June 8, 2017

Conditions

Chronic Low-back Pain

Outcome Measures

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?"

    Day 30

Secondary Outcomes (3)

  • Evaluate the analgesic effect of paravertebral injections of BoNT-A, 90 days after its administration in chronic LBP sufferers.

    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.

    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.

    Day 120

Study Arms (2)

botulinum toxin A

EXPERIMENTAL
Drug: Botox

Placebo

PLACEBO COMPARATOR
Drug: Placebos

Interventions

BotoxDRUG

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

botulinum toxin A
PlacebosDRUG

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

Placebo

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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),
  • same long-term chronic pain treatment for at least 6 weeks

You may not qualify if:

  • age under 18 or over 55 years (to avoid secondary causes of low back pain, like spinal tumor),
  • ongoing pregnancy or breast-feeding,
  • 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).
  • No patient was allowed to take opiates during the time of the study,
  • facet joint injections were also not permitted during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bordeaux University Hospital

Bordeaux, 33000, France

Location

Related Publications (2)

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

    BACKGROUND

  • 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.

    PMID: 29141611DERIVED

Related Links

MeSH Terms

Interventions

Botulinum Toxins, Type A

Intervention Hierarchy (Ancestors)

Botulinum ToxinsMetalloendopeptidasesEndopeptidasesPeptide HydrolasesHydrolasesEnzymesEnzymes and CoenzymesMetalloproteasesBacterial ProteinsProteinsAmino Acids, Peptides, and ProteinsBacterial ToxinsToxins, BiologicalBiological Factors

Study Officials

  • Matthieu DE SEZE

    University Hospital, Bordeaux

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Model Details: 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)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 29, 2017

First Posted

June 9, 2017

Study Start

November 18, 2003

Primary Completion

May 5, 2005

Study Completion

May 8, 2005

Last Updated

June 9, 2017

Record last verified: 2017-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)