Skip to content

Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain

TerminatedPhase 2NCT02221648
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain. The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.

Study details

Official title
Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Conditions
Interventions
Sponsor
Yale University
Collaborators
Ipsen
Start date
2012-12
Primary completion
2015-09
Sex
All
Age range
from 18 Years to 80 Years
Results posted
Yes, on ClinicalTrials.gov
Countries
United States
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Age 18-80, all ethnic groups, races, both sexes. * Diagnosis of chronic low back pain (longer than 3 months). * Pain of moderate to severe intensity (VAS 4 or higher). * Subjects who are able to read, speak, and understand English. Exclusion Criteria: Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders). * Hypersensitivity to any botulinum toxin product or is recipient * Allergy to albumin. Lactose or cow milk protein * Infection in the proposed injection site. * Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc). * Active breast feeding. * Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol. * Patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction (anticholinergics , muscle relaxants) * Subjects who are younger than 18 years of age. * Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral Sclerosis. * Evidence of acute pathology on neuro-imaging. * Axis I diagnosis determined by a neurologist or psychiatrist. * Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment. * Received botulinum toxin injections in the past 3 months. * History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02221648