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

• Status: Terminated
• Trial end date: 2015-09-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yale University
• Collaborator: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA

Criteria

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