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

CompletedPhase 3NCT00246155
View the official record on ClinicalTrials.gov

Recruiting status changes often. Contact the study team listed on ClinicalTrials.gov, and talk to your doctor before joining a study.

This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.

Brief summary (from the registry)

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.

Study details

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
Conditions
Sponsor
Ipsen
Start date
2005-01
Primary completion
2005-07-01
Sex
All
Age range
from 18 Years to 60 Years
Results posted
No results posted in this snapshot
Countries
South Korea
Total sites listed
1

Eligibility criteria

Show eligibility criteria (verbatim from the registry)
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.

Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT00246155