Clinical trial NCT02221648: Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Official title: Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Lower Back Pain
Keywords: Back
Pain
Muscle
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: Ipsen
First posted: 2014-08-20
Enrollment: 43
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed description: This is an investigator initiated, randomized, double blind, placebo-controlled study. A total of 90 patients will be enrolled in the study. The study will be conducted over 4 months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (\>3 months) who meet inclusion and exclusion criteria and wish to participate in the study may be enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0). During the baseline visit, subjects will be given the official approved consent form to read and ask questions. Participants to this study will also receive a copy of the Dysport Risk Evaluation and Mitigation Strategy (REMS) statement. After obtaining informed consent signed by the subject, the subjects will be randomization into the Dysport or placebo group. The randomizing will be performed by a nurse and the information will be kept in a pass-worded computer. Blinding means that neither the participant nor the clinical rater will know which group the participant has been initially been assigned.

Each subject will have a neurological examination and fill a demographic form and complete four rating questionnaires (appendix II-V). These include a visual analogue scale for pain (0 to 10) and three quality of life questionnaires which depict quality of life (the American Chronic Pain Association's Quality of Life Scale), how pain affects ability to manage everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical and emotional health (Short Form-36). Patients will then receive an injection of either abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain location. In the case of unilateral pain, this would amount to 500 units total, and in the case of bilateral pain, to 1000 units total, of Dysport per session.

The primary outcome of the study is number of patients with VAS \< 4 ( no or subtle pain) at week 6 after placebo or Dysport injection.

Eligibility 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

Primary outcomes:
measure: Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
timeFrame: 6 weeks
Secondary outcomes:
measure: Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)
timeFrame: 6 weeks
measure: Number of Subjects Showing Improvement on Quality of Life Scale for Pain
timeFrame: 6 weeks
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Medical Group
state: Connecticut
Study officials:
affiliation: Yale University
name: Bahman Jabbari, MD
role: PRINCIPAL_INVESTIGATOR
References: