Lower Back PainPhase 2NCT02221648
Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
A Phase 2 study testing AbobotulinumtoxinA Treatment in people with Lower Back Pain, run by Yale University at 1 site in United States.
Trial summary
The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain. The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Lower Back Pain
- What is being tested?
- AbobotulinumtoxinA Treatment
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 43 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2012to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-80, all ethnic groups, races, both sexes.
- Diagnosis of chronic low back pain (longer than 3 months).
- Pain of moderate to severe intensity (VAS 4 or higher).
- Subjects who are able to read, speak, and understand English.
Who cannot join
- Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
- Hypersensitivity to any botulinum toxin product or is recipient
- Allergy to albumin. Lactose or cow milk protein
- Infection in the proposed injection site.
- Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
- Active breast feeding.
Show all 15Show fewer
- Enrollment in any clinical trial (currently or within the past 3 months) in which treatments are imposed by a protocol.
- Patients taking high doses of aminoglycosides or other drugs affecting the function of neuromuscular junction (anticholinergics , muscle relaxants)
- Subjects who are younger than 18 years of age.
- Neuromuscular-junction disorders and motor neuron disease such as Amyotrophic Lateral Sclerosis.
- Evidence of acute pathology on neuro-imaging.
- Axis I diagnosis determined by a neurologist or psychiatrist.
- Anesthetic medications within two weeks and corticosteroid injections within 4 weeks of enrollment.
- Received botulinum toxin injections in the past 3 months.
- History of low back surgery , evidence of acute disc or severe lumbar stenosis in MRI
Trial locations and contacts
1 site in 1 country.
About this study
The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.
The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.
Read the detailed description
This is an investigator initiated, randomized, double blind, placebo-controlled study. A total of 90 patients will be enrolled in the study. The study will be conducted over 4 months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (>3 months) who meet inclusion and exclusion criteria and wish to participate in the study may be enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0). During the baseline visit, subjects will be given the official approved consent form to read and ask questions. Participants to this study will also receive a copy of the Dysport Risk Evaluation and Mitigation Strategy (REMS) statement. After obtaining informed consent signed by the subject, the subjects will be randomization into the Dysport or placebo group. The randomizing will be performed by a nurse and the information will be kept in a pass-worded computer. Blinding means that neither the participant nor the clinical rater will know which group the participant has been initially been assigned.
Each subject will have a neurological examination and fill a demographic form and complete four rating questionnaires (appendix II-V). These include a visual analogue scale for pain (0 to 10) and three quality of life questionnaires which depict quality of life (the American Chronic Pain Association's Quality of Life Scale), how pain affects ability to manage everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical and emotional health (Short Form-36). Patients will then receive an injection of either abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain location. In the case of unilateral pain, this would amount to 500 units total, and in the case of bilateral pain, to 1000 units total, of Dysport per session.
The primary outcome of the study is number of patients with VAS < 4 ( no or subtle pain) at week 6 after placebo or Dysport injection.
- Conditions
- Lower Back Pain
- Being tested
- Placebo, AbobotulinumtoxinA Treatment
- Keywords
- Back, Pain, Muscle
- Medical subject headings
- Low Back Pain, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlaceboDrug
Subjects will be randomization to receive either the study drug or the placebo group.
AbobotulinumtoxinA TreatmentDrug
Also called Dysport
Subjects receive intervention injections with the study drug arbobotulinumtoxinA.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Subjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive. Receives: Drug: Placebo |
| AbobotulinumtoxinA Treatment | Active comparator | Subjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA. Receives: Drug: AbobotulinumtoxinA Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
Measured: 6 weeks
Secondary outcomes (2)
Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)
The PGIC is a 7 point scale that requires the clinician to assess how much the patient's pain has improved or worsened relative to a baseline state at the beginning of the intervention. and rated as:
No change (or condition has gotten worse) (1) Almost the same, hardly any change at all (2) A little better, but no noticeable change (3) Somewhat better, but the change has not made any real difference (4) Moderately better, and a slight but noticeable change (5) Better and a definite improvement that has made a real and worthwhile difference (6) A great deal better and a considerable improvement that has made all the difference (7)
This outcome is number of patients who chose a 6 or above on the PGIC 6 weeks after treatment
Measured: 6 weeks
Number of Subjects Showing Improvement on Quality of Life Scale for Pain
The Quality of Life Scale: A Measure of Function for People With Pain was developed by the American Chronic Pain Association (ACPA). The patient is asked to rank their quality of life on a scale of zero (non-functioning) to 10 (normal quality of life). Improvement was defined as 2 or more grades of improvement on the scale.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2014 (estimated)
- Study startDec 2012
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: PI retired and moved- funding sponsor contacted and Oked
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Lower Back PainStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 43 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Collaborators
- Ipsen
- Responsible party
- Sponsor
- Investigators
- Bahman Jabbari, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02221648
- Sponsor's protocol ID
- 1210011010
- Status last verified
- Jul 2016
- First submitted
- 1 Apr 2014
- Last updated
- 20 Jul 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation of Efficacy of Botulinum Toxin A (Dysport) in Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02221648
- Acronym / sponsor ID
- 1210011010
- Conditions
- Lower Back Pain
- Keywords
- Back, Pain, Muscle
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: PI retired and moved- funding sponsor contacted and Oked
- Enrolment
- 43 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- Ipsen
- Study start
- Dec 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 20 Aug 2014 (estimated)
- Results
- Posted 8 Mar 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The scientific aim of this study is to investigate the efficacy of abobotulinumtoxinA (Dysport - Ipsen Pharmaceuticals) in chronic low back pain.
The investigators hypothesis is that injection of Dysport brand of botulinum toxin type A into erector spinae muscles (extensors of the spine) can relieve low back pain through anti-spasm and analgesic effect of botulinum toxin.
Detailed description
This is an investigator initiated, randomized, double blind, placebo-controlled study. A total of 90 patients will be enrolled in the study. The study will be conducted over 4 months. It includes 4 visits and 4 telephone calls. Patients with chronic low back pain (>3 months) who meet inclusion and exclusion criteria and wish to participate in the study may be enrolled. Those who become enrolled will be scheduled for a baseline visit (Week 0). During the baseline visit, subjects will be given the official approved consent form to read and ask questions. Participants to this study will also receive a copy of the Dysport Risk Evaluation and Mitigation Strategy (REMS) statement. After obtaining informed consent signed by the subject, the subjects will be randomization into the Dysport or placebo group. The randomizing will be performed by a nurse and the information will be kept in a pass-worded computer. Blinding means that neither the participant nor the clinical rater will know which group the participant has been initially been assigned.
Each subject will have a neurological examination and fill a demographic form and complete four rating questionnaires (appendix II-V). These include a visual analogue scale for pain (0 to 10) and three quality of life questionnaires which depict quality of life (the American Chronic Pain Association's Quality of Life Scale), how pain affects ability to manage everyday life (Oswestry Low Back Pain Disability Questionnaire), and overall physical and emotional health (Short Form-36). Patients will then receive an injection of either abobotulinumA (Dysport) or normal saline. Dysport or saline will be administered into the paraspinal muscles (extensors or erector spinae) at five levels (L1-L5), regardless of pain location. In the case of unilateral pain, this would amount to 500 units total, and in the case of bilateral pain, to 1000 units total, of Dysport per session.
The primary outcome of the study is number of patients with VAS < 4 ( no or subtle pain) at week 6 after placebo or Dysport injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboSubjects will be randomization to receive injections with either the study drug (abobotulinumtoxinA) or the placebo group. The subjects will be blinded to which intervention they will receive. |
| AbobotulinumtoxinA Treatment | Active comparator | Drug: AbobotulinumtoxinA TreatmentSubjects will be randomized to receive intervention injections with the study drug arbobotulinumtoxinA. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-80, all ethnic groups, races, both sexes.
- Diagnosis of chronic low back pain (longer than 3 months).
- Pain of moderate to severe intensity (VAS 4 or higher).
- Subjects who are able to read, speak, and understand English.
Key exclusion criteria (15 listed)
- Existing significant acute medical condition (i.e. cardiovascular, endocrine, hematologic, neoplastic, infectious, or autoimmune disorders).
- Hypersensitivity to any botulinum toxin product or is recipient
- Allergy to albumin. Lactose or cow milk protein
- Infection in the proposed injection site.
- Pregnancy or planned pregnancy (determined by urine pregnancy test). The women of childbearing age should use a reliable mode of contraception during the study period (abstinence, etc).
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 |
|---|---|---|
| PlaceboSubjects will be randomization to receive either the study drug or the placebo group. | Drug | Placebo |
| AbobotulinumtoxinA TreatmentAlso: DysportSubjects receive intervention injections with the study drug arbobotulinumtoxinA. | Drug | AbobotulinumtoxinA Treatment |
Primary outcome
Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS)
Time frame: 6 weeks
The primary outcome measure in this protocol is the proportion of subjects that have VAS <4 (patients with no or mild pain) at week 6. The pain VAS is a continuous scale comprised of a line 10 centimeters in length, anchored by 2 verbal descriptors, one for each symptom extreme. For pain intensity, the scale is anchored by "no pain" (score of 0) and "worst imaginable pain" (score of 10).
2 secondary outcomes
Number of Patients With Improved Pain Using the Patient Global Impression of Change (PGIC)
Time frame: 6 weeks
Number of Subjects Showing Improvement on Quality of Life Scale for Pain
Time frame: 6 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jul 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Bahman Jabbari, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing AbobotulinumtoxinA Treatment in people with Lower Back Pain, run by Yale University at 1 site in United States.
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 4 inclusion and 15 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: stopped early, as of the sponsor's last update on 20 Jul 2016. 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 United States. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Mar 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Proportion of Participants With Mild or no Pain on Visual Analog Scale (VAS) (time frame: 6 weeks). 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 20 Jul 2016.