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

Condition(s) targeted: Low Back Pain

Intervention: Botulinum toxin type A (Dysport) (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Ipsen

Official(s) and/or principal investigator(s):
Stefan Lempereur, MD, Study Director, Affiliation: Ipsen

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.

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 design: Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study

Primary outcome:

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:

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.

Minimum age: 18 Years. Maximum age: 60 Years. Gender(s): Both.

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.

Wooridul Spine Hospital, Seoul 135-100, Korea, Republic of

Starting date: January 2005
Last updated: October 10, 2006