Skip to main content
OpenTrials
Completed

NCT Number: NCT00246155

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Low Back Pain Back Pain Bronchial Diseases Bronchiolitis Bronchiolitis Obliterans Bronchiolitis Obliterans Syndrome Bronchitis Graft vs Host Disease Immune System Diseases Lung Diseases Lung Diseases, Obstructive Neurologic Manifestations Organizing Pneumonia Pain Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases Signs and Symptoms

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Wooridul Spine Hospital

Seoul, 135-100, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Botulinum toxin type A

Biological

Other names: AbobotulinumtoxinA (Dysport®)

Primary outcomes

  1. 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.

  2. 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 outcomes

  1. Changes of the total isometric lumbar extensor strength and separated angle using lumbar MedX machine.

  2. Association between pain reduction and strength. Measurements will be performed at baseline, and 1, 2, 3 months after injection.

  3. Change of the lumbar extensor muscular size in CT Measurement will be performed at baseline and 3 months after injection.

Sponsors and collaborators

Lead sponsor

Ipsen

Industry

Registry information

Official study 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

Important dates

Study start
2005
Primary completion
2005
Study completion
2005
First posted
Oct 31, 2005
Registry last updated
Jul 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.