Status:
COMPLETED
Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
Lead Sponsor:
Ipsen
Conditions:
Low Back Pain
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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 s...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2005
Estimated Enrollment :
35 Patients enrolled
Trial Details
Trial ID
NCT00246155
Start Date
January 1 2005
End Date
July 1 2005
Last Update
July 26 2019
Active Locations (1)
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1
Wooridul Spine Hospital
Seoul, South Korea, 135-100