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

NCT ID: NCT00246155

Last Updated: 2019-07-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 35 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-01-31
• Study Completion Date: 2005-07-01

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

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Botulinum toxin type A

Intervention Type: BIOLOGICAL

Other Intervention Names

AbobotulinumtoxinA (Dysport®)

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ipsen

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ipsen Medical Director

Role: STUDY_DIRECTOR

Ipsen

Locations

Wooridul Spine Hospital

Seoul, , South Korea

Countries

South Korea

Other Identifiers

A-38-52120-103

Identifier Type: -

Identifier Source: org_study_id