Discogenic PainPhase 4NCT01077947
Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
A Phase 4 study testing Functional anesthetic discography and Provocative Discography in people with Discogenic Pain and Low Back Pain, run by Northwestern University.
Trial summary
Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Read more about this study
- Who is it for?
- Ages 21 to 65 years
- Conditions the study is for
- Discogenic Pain, Low Back Pain
- What is being tested?
- Functional anesthetic discography and Provocative Discography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2010to Feb 2014
- Phase
- Phase 4
- 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 21 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 21 to 65 years.
- Symptoms of at least 6 months duration.
- Primarily axial low back pain.
- At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
- Patients with overall pain scores of greater than 6/10 (NRS).
- Recent (within the past 6 months) lumbar spine MRI showing: disc desiccation and loss of disc height of at least one disc level.
Who cannot join
- History of previous spine surgery.
- MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.
- Clinical or radiological evidence of significant:
- Disc herniation
- Spinal Stenosis
- Spinal Deformity
Show all 18Show fewer
- Spondylolisthesis
- Spinal instability or pars-defect
- Facet Syndrome
- Sacroiliac Joint Dysfunction
- Myofascial Pain Syndrome
- Fibromyalgia
- Current issues of:
- Litigation
- Disability
- Drug addiction or substance abuse
- Chronic pain medication abuse
- Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.
About this study
Official title: Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.
- Conditions
- Discogenic Pain, Low Back Pain
- Being tested
- Functional anesthetic discography, Provocative Discography
- Keywords
- low back pain, spinal fusion, Primarily axial low back pain
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional anesthetic discographyProcedure or surgery
Functional anesthetic discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
Provocative DiscographyProcedure or surgery
Provocative Discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition.
| Study group | Role | What they receive |
|---|---|---|
| Functional anesthetic discography | Active comparator | The patients disc levels for surgical treatment will be based exclusively on their Functional anesthetic discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography:
1. Loss of disc signal intensity on T-2 weighted sagittal MR images.
2. Loss of disc height on sagittal MR images.
Patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery by research personnel. Patients will be asked to complete questionnaires before their discography and at every follow-up visit. Receives: Procedure: Functional anesthetic discography |
| Provocative Discography | Active comparator | The patients disc levels for surgical treatment will be based exclusively on their Provocative Discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography:
1. Loss of disc signal intensity on T-2 weighted sagittal MR images.
2. Loss of disc height on sagittal MR images.
The control disc, in the case provocative discography group must appear normal on the MRI - must have preserved disc height and central disc signal intensity on T-2 weighted images. The provocative discography will be performed using the standard IASP criteria. The patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery. Receives: Procedure: Provocative Discography |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity)
Standard Morphine Equivalent intake
Measured: One Year
Secondary outcomes (3)
Physical functioning
Oswestry Disability Index
Measured: One Year
Quality of Life
SF-36 health survey
Measured: One Year
Patient Satisfaction
Patient Global Impression of Change
Measured: One Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Mar 2010 (estimated)
- Study startFeb 2010
- Primary completionFeb 2014 (estimated)
- Study completionFeb 2014 (estimated)
Why it stopped: Internal
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Discogenic PainStudies of the same condition, open and under way.
- More trials run by Northwestern 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Collaborators
- Medtronic Spine LLC
- Investigators
- Khalid Malik, M.D., Principal investigator, Department of Anesthesiology, Northwestern University, Feinberg School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01077947
- Sponsor's protocol ID
- STU00006921
- Status last verified
- Sep 2016
- First submitted
- 26 Feb 2010
- Last updated
- 13 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Value of Functional Anesthetic and Provocative Discography in the Surgical Treatment of Discogenic Pain
- ClinicalTrials.gov ID
- NCT01077947
- Acronym / sponsor ID
- STU00006921
- Conditions
- Discogenic Pain, Low Back Pain
- Keywords
- low back pain, spinal fusion, Primarily axial low back pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Collaborators
- Medtronic Spine LLC
- Study start
- Feb 2010
- Primary completion
- Feb 2014 (estimated)
- Study completion
- Feb 2014 (estimated)
- First posted
- 1 Mar 2010 (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.
Although discography and spinal imaging techniques, either alone or in combination, are commonly used to diagnose discogenic pain, their exact role in predicting surgical results are poorly defined. Our aim in this study is to compare the ability of Functional anesthetic discography (FAD), and Provocative Discography (PD) to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. Patients with discogenic pain have better outcomes if the disc levels for the fusion surgery are identified by using FAD compared to similar disc level identification by PD.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Functional anesthetic discography | Active comparator | Procedure: Functional anesthetic discographyThe patients disc levels for surgical treatment will be based exclusively on their Functional anesthetic discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography: 1. Loss of disc signal intensity on T-2 weighted sagittal MR images. 2. Loss of disc height on sagittal MR images. Patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery by research personnel. Patients will be asked to complete questionnaires before their discography and at every follow-up visit. |
| Provocative Discography | Active comparator | Procedure: Provocative DiscographyThe patients disc levels for surgical treatment will be based exclusively on their Provocative Discography results. The discography will be performed at a maximum of two disc levels. Discs showing the following MRI findings will be considered for discography: 1. Loss of disc signal intensity on T-2 weighted sagittal MR images. 2. Loss of disc height on sagittal MR images. The control disc, in the case provocative discography group must appear normal on the MRI - must have preserved disc height and central disc signal intensity on T-2 weighted images. The provocative discography will be performed using the standard IASP criteria. The patients will be followed-up at 3 weeks, 3 months, 6 months and 1 year after the surgery. |
Who may qualify
- Ages
- 21 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age between 21 to 65 years.
- Symptoms of at least 6 months duration.
- Primarily axial low back pain.
- At least 6 months of conservative treatment, including, physical therapy, injections, chiropractic etc.
- Patients with overall pain scores of greater than 6/10 (NRS).
Key exclusion criteria (18 listed)
- History of previous spine surgery.
- MRI changes at more than two disc levels on the recent (within the past 6 months) lumbar spine MRI.
- Clinical or radiological evidence of significant:
- Current issues of:
- Current diagnosis of and medication use for unstable anxiety, depression, and/or behavioral disorders.
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 |
|---|---|---|
| Functional anesthetic discographyFunctional anesthetic discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. | Procedure or surgery | Functional anesthetic discography |
| Provocative DiscographyProvocative Discography will be performed to diagnose discogenic pain and to correctly identify the disc levels for the surgical treatment. Proper identification for disc levels should improve the overall results of surgery for this condition. | Procedure or surgery | Provocative Discography |
Primary outcome
Pain
Time frame: One Year
Numerical Rating Scale (11-point numerical rating, 0-10, scale of pain intensity) Standard Morphine Equivalent intake
3 secondary outcomes
Physical functioning
Time frame: One Year
Quality of Life
Time frame: One Year
Patient Satisfaction
Time frame: One Year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2016.
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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.
Khalid Malik, M.D. principal investigator
Department of Anesthesiology, Northwestern University, Feinberg School of Medicine
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Functional anesthetic discography and Provocative Discography in people with Discogenic Pain and Low Back Pain, run by Northwestern University.
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 18 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: withdrawn, as of the sponsor's last update on 13 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was withdrawn before enrolling participants, so there are no results.
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 (time frame: One Year). 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 13 Sep 2016.