Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Stopped early · Phase 2 · Has a placebo group
Conditions studied: Lower Back Pain
In brief
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.
Key facts
- Study ID
- NCT02221648
- Run by
- Yale University
- People needed
- 43
- Starts
- 2012-12-01
- Expected to finish
- 2015-09-01
- Last updated by the study team
- 2016-07-20
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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
Where it is running
- Yale Medical Group — New Haven, Connecticut, United States
Full record on ClinicalTrials.gov
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