Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
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|ClinicalTrials.gov Identifier: NCT00246155|
Recruitment Status : Completed
First Posted : October 31, 2005
Last Update Posted : October 11, 2006
|Condition or disease||Intervention/treatment||Phase|
|Low Back Pain||Drug: Botulinum toxin type A (Dysport)||Phase 3|
|Study Type :||Interventional (Clinical Trial)|
|Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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 Start Date :||January 2005|
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00246155
|Korea, Republic of|
|Wooridul Spine Hospital|
|Seoul, Korea, Republic of, 135-100|
|Study Director:||Stefan Lempereur, MD||Ipsen|