Low Back PainPhase 3NCT00246155
Study on the Effects of Botulinum Toxin Type A on Back Muscle in Chronic Low Back Pain
A Phase 3 study testing Botulinum toxin type A in people with Low Back Pain, run by Ipsen at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Botulinum toxin type A
- How many people
- 35 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2005to 1 Jul 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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
- Being tested
- Botulinum toxin type A
- Keywords
- chronic, muscular
- Medical subject headings
- Low Back Pain, Bronchiolitis Obliterans Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Botulinum toxin type ABiological
Also called AbobotulinumtoxinA (Dysport®)
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2005 (estimated)
- Study startJan 2005
- Primary completion1 Jul 2005
- Study completion1 Jul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by IpsenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ipsen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ipsen Medical Director, Study director, Ipsen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00246155
- Sponsor's protocol ID
- A-38-52120-103
- Status last verified
- Jul 2019
- First submitted
- 27 Oct 2005
- Last updated
- 26 Jul 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00246155
- Acronym / sponsor ID
- A-38-52120-103
- Conditions
- Low Back Pain
- Keywords
- chronic, muscular
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- IpsenIndustry (pharma, biotech, devices)
- Study start
- Jan 2005
- Primary completion
- 1 Jul 2005 (actual)
- Study completion
- 1 Jul 2005 (actual)
- First posted
- 31 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Botulinum toxin type AAlso: AbobotulinumtoxinA (Dysport®) | Biological | – |
Primary outcome
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.
3 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ipsen Medical Director study director
Ipsen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Botulinum toxin type A in people with Low Back Pain, run by Ipsen at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jul 2019.