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

This study has been completed.
Sponsor:
Information provided by:
Ipsen
ClinicalTrials.gov Identifier:
NCT00246155
First received: October 27, 2005
Last updated: October 10, 2006
Last verified: October 2006
  Purpose

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.


Condition Intervention Phase
Low Back Pain
Drug: Botulinum toxin type A (Dysport)
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Ipsen:

Primary Outcome Measures:
  • 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:
  • 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.

Estimated Enrollment: 35
Study Start Date: January 2005
  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00246155

Locations
Korea, Republic of
Wooridul Spine Hospital
Seoul, Korea, Republic of, 135-100
Sponsors and Collaborators
Ipsen
Investigators
Study Director: Stefan Lempereur, MD Ipsen
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00246155     History of Changes
Other Study ID Numbers: A-38-52120-103
Study First Received: October 27, 2005
Last Updated: October 10, 2006
Health Authority: South Korea: Korea Food and Drug Administration (KFDA)

Keywords provided by Ipsen:
chronic
muscular

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Botulinum Toxins
Botulinum Toxins, Type A
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses
Pharmacologic Actions
Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

ClinicalTrials.gov processed this record on September 18, 2014