Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|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|
- 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.
- 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.
|Study Start Date:||January 2005|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00246155
|Korea, Republic of|
|Wooridul Spine Hospital|
|Seoul, Korea, Republic of, 135-100|
|Study Director:||Stefan Lempereur, MD||Ipsen|