Back to resultsStudy on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
Primary Purpose
Low Back Pain
Status
Completed
Phase
Phase 3
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Botulinum toxin type A
Sponsored by
About this trial
This is an interventional treatment trial for Low Back Pain focused on measuring chronic, muscular
Eligibility Criteria
Inclusion Criteria: Suffering from muscular low back pain (between L-1 and S-1 level). Symptoms of more than six months duration. No benefit from previous treatments. Patient must present with bilaterally more than 2 active trigger points (TrPs) in the region of the low back musculature. CT scan or MRI examination of the lumbar spine was performed within the past year. Absence of significant pathology, such as bone fracture, nerve damage or severe psychiatric condition. Exclusion Criteria: Constant or persistent severe pain due to nerve root compression or fibromyalgia. The patient has received surgery on the spine. Other musculoskeletal disabilities e.g. myasthenia gravis, or disorders of the neuromuscular junction. Any serious pathology, such as cancer, systemic inflammatory disease, vertebral fractures, neurological signs, spinal infection. Epidural injection of local anaesthetics and steroids within 12 weeks proceeding inclusion. Trigger point injection of local anaesthetics and steroid within 8 weeks proceeding inclusion. Pain associated with urinary tract infections, or gynaecological disorders. Bleeding disturbances or currently using coumarin derivatives.
Sites / Locations
- Wooridul Spine Hospital
Outcomes
Primary Outcome Measures
Pain reduction as assessed by the mean Visual Analogue Scale (VAS) during last 2 weeks. Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
Improvement in daily life activities and quality of life using the Oswestry Low Back Pain Questionnaire (OLBPQ), and Short Form-36 (SF-36). Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
Secondary Outcome Measures
Changes of the total isometric lumbar extensor strength and separated angle using lumbar MedX machine.
Association between pain reduction and strength. Measurements will be performed at baseline, and 1, 2, 3 months after injection.
Change of the lumbar extensor muscular size in CT Measurement will be performed at baseline and 3 months after injection.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00246155
Brief Title
Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
Official Title
A Prospective Study to Evaluate the Potential Effects on Function and Size in Back Muscle After Injection of Botulinum Toxin Type A (Dysport®) in the Treatment of Chronic Low Back Pain
Study Type
Interventional
2. Study Status
Record Verification Date
July 2019
Overall Recruitment Status
Completed
Study Start Date
January 2005 (undefined)
Primary Completion Date
July 1, 2005 (Actual)
Study Completion Date
July 1, 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ipsen
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to analyse the changes in back muscle size and strength following use of Dysport®, and to establish whether there is any association between pain reduction and change in strength, in patients suffering from chronic low back pain.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain
Keywords
chronic, muscular
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Biological
Intervention Name(s)
Botulinum toxin type A
Other Intervention Name(s)
AbobotulinumtoxinA (Dysport®)
Primary Outcome Measure Information:
Title
Pain reduction as assessed by the mean Visual Analogue Scale (VAS) during last 2 weeks. Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
Title
Improvement in daily life activities and quality of life using the Oswestry Low Back Pain Questionnaire (OLBPQ), and Short Form-36 (SF-36). Assessments will be made at the initial time before injection and 1, 2, 3 months after injection.
Secondary Outcome Measure Information:
Title
Changes of the total isometric lumbar extensor strength and separated angle using lumbar MedX machine.
Title
Association between pain reduction and strength. Measurements will be performed at baseline, and 1, 2, 3 months after injection.
Title
Change of the lumbar extensor muscular size in CT Measurement will be performed at baseline and 3 months after injection.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Suffering from muscular low back pain (between L-1 and S-1 level).
Symptoms of more than six months duration.
No benefit from previous treatments.
Patient must present with bilaterally more than 2 active trigger points (TrPs) in the region of the low back musculature.
CT scan or MRI examination of the lumbar spine was performed within the past year.
Absence of significant pathology, such as bone fracture, nerve damage or severe psychiatric condition.
Exclusion Criteria:
Constant or persistent severe pain due to nerve root compression or fibromyalgia.
The patient has received surgery on the spine.
Other musculoskeletal disabilities e.g. myasthenia gravis, or disorders of the neuromuscular junction.
Any serious pathology, such as cancer, systemic inflammatory disease, vertebral fractures, neurological signs, spinal infection.
Epidural injection of local anaesthetics and steroids within 12 weeks proceeding inclusion.
Trigger point injection of local anaesthetics and steroid within 8 weeks proceeding inclusion.
Pain associated with urinary tract infections, or gynaecological disorders.
Bleeding disturbances or currently using coumarin derivatives.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ipsen Medical Director
Organizational Affiliation
Ipsen
Official's Role
Study Director
Facility Information:
Facility Name
Wooridul Spine Hospital
City
Seoul
ZIP/Postal Code
135-100
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
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