Clinical trial NCT00246155: 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
Overall status: COMPLETED
Phase: PHASE3
Conditions: Low Back Pain
Keywords: chronic
muscular
Lead sponsor: Ipsen
Sponsor class: INDUSTRY
First posted: 2005-10-30
Enrollment: 35
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: 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.
measure: 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 outcomes:
measure: Changes of the total isometric lumbar extensor strength and separated angle using lumbar MedX machine.
measure: Association between pain reduction and strength. Measurements will be performed at baseline, and 1, 2, 3 months after injection.
measure: Change of the lumbar extensor muscular size in CT Measurement will be performed at baseline and 3 months after injection.
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Wooridul Spine Hospital
Study officials:
affiliation: Ipsen
name: Ipsen Medical Director
role: STUDY_DIRECTOR
References: