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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
History of Changes
  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:

MedlinePlus related topics: Back Pain Botox
U.S. FDA Resources

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
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, Type A
Botulinum Toxins
 Neuromuscular Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Dyskinesia Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 22, 2013