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

Ipsen

Status and phase

Completed

Phase 3

Conditions

Low Back Pain

Treatments

Biological: Botulinum toxin type A

Study type

Interventional

Funder types

Industry

Identifiers

NCT00246155

A-38-52120-103

Details and patient eligibility

About

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.

Enrollment

35 patients

Sex

All

Ages

18 to 60 years old

Volunteers

No Healthy Volunteers

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.