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

Phase 3

Completed

• Conditions: Low Back Pain

• Registration Number: NCT00246155
• Lead Sponsor: Ipsen

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2005-01
• Primary Completion: 2005-07-01
• Study Completion: 2005-07-01
• Study First Submitted: 2005-10-27
• Study First Submitted QC: 2005-10-27
• Study First Posted: 2005-10-30
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-25
• Last Update Posted: 2019-07-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 35

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
Changes of the total isometric lumbar extensor strength and separated angle using lumbar MedX machine.
Change of the lumbar extensor muscular size in CT Measurement will be performed at baseline and 3 months after injection.
Association between pain reduction and strength. Measurements will be performed at baseline, and 1, 2, 3 months after injection.

Trial Locations

Locations (1)

Wooridul Spine Hospital; 🇰🇷 Seoul, Korea, Republic of