Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain

• Status: Completed
• Trial end date: 0000-00-00
• Target enrollment: 35
• Participant gender: Both

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ipsen
• Treatments: abobotulinumtoxinA; Botulinum Toxins; Botulinum Toxins, Type A; incobotulinumtoxinA; onabotulinumtoxinA
• Last Updated: 2006-10-10

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.