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

NCT00246155 | Completed Phase 3

• 1 other identifier: A-38-52120-103
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Low Back Pain

Keywords

chronic; muscular

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (3)

• 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.

Interventions

Botulinum toxin type A BIOLOGICAL

Also known as: AbobotulinumtoxinA (Dysport®)

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• Pain associated with urinary tract infections, or gynaecological disorders.
• Bleeding disturbances or currently using coumarin derivatives.

Sponsors & Collaborators

• Ipsen: lead

Study Sites (1)

Wooridul Spine Hospital

Seoul, 135-100, South Korea

Location

MeSH Terms

Conditions

Low Back Pain; Bronchiolitis Obliterans Syndrome

Interventions

Botulinum Toxins, Type A; abobotulinumtoxinA

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Botulinum Toxins; Metalloendopeptidases; Endopeptidases; Peptide Hydrolases; Hydrolases; Enzymes; Enzymes and Coenzymes; Metalloproteases; Bacterial Proteins; Proteins; Amino Acids, Peptides, and Proteins; Bacterial Toxins; Toxins, Biological; Biological Factors

Study Officials

• Ipsen Medical Director

  Ipsen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2005
• First Posted: October 31, 2005
• Study Start: January 1, 2005
• Primary Completion: July 1, 2005
• Study Completion: July 1, 2005
• Last Updated: July 26, 2019

Record last verified: 2019-07

Locations

KR (1)