Low Back Pain
Conditions
Keywords
chronic, muscular
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.
Interventions
BIOLOGICALBotulinum toxin type A
Sponsors
Ipsen
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
South Korea
Outcome results
None listed