Low Back PainNCT02329951
Predictive Factors for LBP Interventional Treatment Outcomes
An observational study of Low Back Pain and Lumbar Radiculopathy, run by Johns Hopkins University at 1 site in United States.
Trial summary
In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical exam, which… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Low Back Pain, Lumbar Radiculopathy
- What is being tested?
- Facet intervention, Sacroiliac joint injection and Epidural steroid injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- How many people
- 346 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to Dec 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with low back or lumbar radicular pain scheduled for an injection
Who may be able to join
- Age > 18 years;
- Pain duration > 6 weeks;
- Low back pain presumed to be secondary to herniated disc or spinal stenosis (e.g. radiculopathy), facet joint pain or SI joint pain;
- For ESI, patients must have leg pain >/= 4/10 or comparable or greater than back pain, along with concordant MRI findings; for SI joint injections, patients must have tenderness overlying the SI joint; for facet joint pain, they must have paraspinal tenderness;
- Patient agrees to have ESI, facet blocks or SI joint injection for diagnostic or therapeutic purposes;
- Average pain score >/= 4/10 over the past week
Who cannot join
- Previous ESI, facet blocks or SI joint injection within the past 2 years;
- Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
- Previous surgery for ESI or facet block;
- Untreated coagulopathy;
- Allergy to contrast dye, bupivacaine or depomethylprednisolone;
- Pregnancy;
- Cannot read or understand English.
Trial locations and contacts
1 site in 1 country.
United States1 site
Johns Hopkins School of Medicine
Baltimore, Maryland, 21205
About this study
Official title: Prospective, Observational Study Evaluating the Ability of Clinical Factors to Predict Interventional Treatment Outcomes for Low Back Pain (LBP)
In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical exam, which includes the assessment of Waddell signs, and querying them regarding factors shown in non-interventional studies or retrospective studies evaluating interventional treatments to be associated with negative treatment outcomes. These factors include the presence of Waddell and other physical exam signs, opioid use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation), procedure-related pain including from a 1 ml standardized injection, obesity, and smoking history. They will then proceed to undergo their scheduled intervention, which will be limited to epidural steroid injections (ESI), facet blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A positive outcome will be defined as 2-point or greater decrease in average pain score at 1-month and a score of > 3 on a 1-5 Likert satisfaction scale. Those with a positive outcome at 1-month will remain in the study and be followed again at 3-months.
Read the detailed description
This will be an observational study with a 3-month follow-up. The course of clinical treatment will be decided by a physician independent of the research. Besides filling out questionnaires and standardized follow-up visits, all subjects will receive the same care they would if they did not participate in the study. The study will be discussed with the subjects and they will be enrolled in the study after it is determined that they meet selection criteria and are scheduled for one of the above injections. They will then fill out 3 questionnaires (Oswestery disability index, Athens insomnia scale, QIDS SR-16. All procedures will be performed with fluoroscopy. Following each procedure, the procedure-related pain will be reported on a 0-10 scale (all patients will receive as much 1% lidocaine local anesthetic as is necessary), including the reported pain to the standardized skin wheal at the start of the procedure.
Patients will then receive standardized epidural steroid injections (transforaminal or interlaminar), sacroiliac joint injections, or facet blocks and radiofrequency denervation if they experience a positive block. Details about these procedures are available upon request.
No patients will be permitted additional interventions between the time of their procedure and follow-up visits. Rescue medications will be in the form of either tramadol, NSAIDs or if the patient is on opioids, a < 20% increase in dose. The first follow-up visit will be scheduled 1 month from the start of treatment for ESI and SI joint patients, and 1 month after RF denervation in positive diagnostic facet block responders. In those facet block patients who obtain prolonged relief from the "diagnostic" medial branch block, follow-up will be 1 month after the block (these patients may proceed to have denervation if their pain recurs after 1 month but before their final 3-month follow-up, and their 3-month follow-up will be 3 months after their medial branch block). A positive outcome will be defined as a greater or equal to 2-point decrease in average LBP (or leg pain for those who underwent an ESI) coupled with a positive satisfaction rating (> 3 on a 5-point scale). Subjects who obtain a positive outcome at their initial 1-month follow-up visit will remain in the study and return for the final 3-month follow-up visit. Those with a negative outcome will exit the study "per protocol" to receive standard care, which may consist of other injections or non-rescue medications such as antidepressants and anticonvulsants. Subjects who obtain a positive outcome at 1-month but experience a recurrence before their 3-month follow-up visit will also exit the study per protocol, with their final outcome measures recorded before they receive standard care.
In those who receive ESI, a smaller parallel study will be done evaluating the association between allergies and outcome. Allergies will be categorized as immunologically based or not.
- Conditions
- Low Back Pain, Lumbar Radiculopathy
- Being tested
- Facet intervention, Sacroiliac joint injection, Epidural steroid injection
- Medical subject headings
- Low Back Pain, Radiculopathy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facet interventionProcedure or surgery
Also called Medial branch block and radiofrequency ablation
Diagnostic block of the nerves innervation the lumbar facet joint. If this block is positive (greater or equal to 50% relief), the participant will proceed to radiofrequency nerve ablation when the pain returns
Sacroiliac joint injectionProcedure or surgery
Injection of steroid and local anesthetic into SI joint
Epidural steroid injectionProcedure or surgery
Transforaminal or interlaminar injection of steroid epidurally
| Study group | Role | What they receive |
|---|---|---|
| Epidural steroid injections | Patients will receive a single interlaminar epidural steroid injection with 60 mg depomethylprednisolone, 1.5 ml of 0.25% bupivacaine and 1.5 ml of saline or a transforaminal epidural steroid injection with 60 mg depomethylprednisolone, 1.5 ml of 0.25% bupivacaine and 0.5 ml of saline. Receives: Procedure: Epidural steroid injection | |
| Facet interventions | Patients will receive diagnostic medial branch (facet joint nerve) blocks with 0.5 ml of 0.5% bupivacaine. If they experience a positive block (> 50% pain relief lasting more than 3 hours), they will then receive radiofrequency denervation. Receives: Procedure: Facet intervention | |
| Sacroiliac joint injections | Patients will receive a single SI joint injection on the affected side(s) with 40 mg depomethylprednisolone and 2 ml of 0.5% bupivacaine. Receives: Procedure: Sacroiliac joint injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean reduction in average pain score
0-10 numerical rating scale for leg pain (ESI) or low back pain (facet procedure or sacroiliac joint injection). Higher scores indicate more pain.
Measured: 1 month
Secondary outcomes (16)
Average back pain score
0-10 numerical rating scale for back pain. Higher scores indicate more pain.
Measured: 1 month
Average leg pain score
0-10 numerical rating scale for leg pain for ESI only. Higher scores indicate more pain.
Measured: 1 month
Worst back pain score
0-10 numerical rating scale for back pain. Higher scores indicate more pain.
Measured: 3 months
Worst leg pain score
0-10 numerical rating scale for leg pain ESI only. Higher scores indicate more pain.
Measured: 3 months
Oswestry disability index score
0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Measured: 1 month
Oswestry disability index score
0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)
Measured: 3 months
Satisfaction score
5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)
Measured: 1 month
Satisfaction score
5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)
Measured: 3 months
Medication reduction
Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)
Measured: 1 month
Medication reduction
Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)
Measured: 3 months
Athens Insomnia Scale
0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)
Measured: 1 month
Athens Insomnia Scale
0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)
Measured: 3 months
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)
Measured: 1 month
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)
Measured: 3 months
Positive outcome
Greater or equal to 2-point change in back pain (facet procedure or sacroiliac joint injection) or leg pain (ESI) plus > 3 score on the 1-5 satisfaction scale. This is either yes or no.
Measured: 1 month
Positive outcome
Greater or equal to 2-point change in back pain (facet procedure or sacroiliac joint injection) or leg pain (ESI) plus > 3 score on the 1-5 satisfaction scale. This is either yes or no.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2015 (estimated)
- Study startDec 2014
- Primary completionMay 2021
- Study completionDec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- More trials run by Johns Hopkins 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 346 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Landstuhl Regional Medical Center, Uniformed Services University of the Health Sciences
- Responsible party
- Sponsor
- Investigators
- Steven P Cohen, MD, Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02329951
- Sponsor's protocol ID
- IRB00050132
- Status last verified
- May 2021
- First submitted
- 30 Dec 2014
- Last updated
- 9 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Cohen SP, Doshi TL, Kurihara C, Reece D, Dolomisiewicz E, Phillips CR, Dawson T, Jamison D, Young R, Pasquina PF. Multicenter study evaluating factors associated with treatment outcome for low back pain injections. Reg Anesth Pain Med. 2022 Feb;47(2):89-99. doi: 10.1136/rapm-2021-103247. Epub 2021 Dec 8.
PubMed 34880117Cohen SP, Doshi TL, Kurihara C, Dolomisiewicz E, Liu RC, Dawson TC, Hager N, Durbhakula S, Verdun AV, Hodgson JA, Pasquina PF. Waddell (Nonorganic) Signs and Their Association With Interventional Treatment Outcomes for Low Back Pain. Anesth Analg. 2021 Mar 1;132(3):639-651. doi: 10.1213/ANE.0000000000005054.
PubMed 32701541
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Observational Study Evaluating the Ability of Clinical Factors to Predict Interventional Treatment Outcomes for Low Back Pain (LBP)
- ClinicalTrials.gov ID
- NCT02329951
- Acronym / sponsor ID
- IRB00050132
- Conditions
- Low Back Pain, Lumbar Radiculopathy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 346 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- Walter Reed National Military Medical Center, Landstuhl Regional Medical Center, Uniformed Services University of the Health Sciences
- Study start
- Dec 2014 (actual)
- Primary completion
- May 2021 (actual)
- Study completion
- Dec 2021 (actual)
- First posted
- 1 Jan 2015 (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.
In this study, we are attempting to determine which factors are associated with interventional treatment outcome for LBP (and to what extent). Up to 346 patients with LBP who are considered to be good candidates for therapeutic interventional procedures will be given a complete history and physical exam, which includes the assessment of Waddell signs, and querying them regarding factors shown in non-interventional studies or retrospective studies evaluating interventional treatments to be associated with negative treatment outcomes. These factors include the presence of Waddell and other physical exam signs, opioid use, allergies, psychopathology, concomitant pain conditions, a 6-point Likert scale on expectations, sleep abnormalities, secondary gain (e.g. medical board or litigation), procedure-related pain including from a 1 ml standardized injection, obesity, and smoking history. They will then proceed to undergo their scheduled intervention, which will be limited to epidural steroid injections (ESI), facet blocks and if positive, radiofrequency denervation, and sacroiliac (SI) joint injections. A positive outcome will be defined as 2-point or greater decrease in average pain score at 1-month and a score of > 3 on a 1-5 Likert satisfaction scale. Those with a positive outcome at 1-month will remain in the study and be followed again at 3-months.
Detailed description
This will be an observational study with a 3-month follow-up. The course of clinical treatment will be decided by a physician independent of the research. Besides filling out questionnaires and standardized follow-up visits, all subjects will receive the same care they would if they did not participate in the study. The study will be discussed with the subjects and they will be enrolled in the study after it is determined that they meet selection criteria and are scheduled for one of the above injections. They will then fill out 3 questionnaires (Oswestery disability index, Athens insomnia scale, QIDS SR-16. All procedures will be performed with fluoroscopy. Following each procedure, the procedure-related pain will be reported on a 0-10 scale (all patients will receive as much 1% lidocaine local anesthetic as is necessary), including the reported pain to the standardized skin wheal at the start of the procedure.
Patients will then receive standardized epidural steroid injections (transforaminal or interlaminar), sacroiliac joint injections, or facet blocks and radiofrequency denervation if they experience a positive block. Details about these procedures are available upon request.
No patients will be permitted additional interventions between the time of their procedure and follow-up visits. Rescue medications will be in the form of either tramadol, NSAIDs or if the patient is on opioids, a < 20% increase in dose. The first follow-up visit will be scheduled 1 month from the start of treatment for ESI and SI joint patients, and 1 month after RF denervation in positive diagnostic facet block responders. In those facet block patients who obtain prolonged relief from the "diagnostic" medial branch block, follow-up will be 1 month after the block (these patients may proceed to have denervation if their pain recurs after 1 month but before their final 3-month follow-up, and their 3-month follow-up will be 3 months after their medial branch block). A positive outcome will be defined as a greater or equal to 2-point decrease in average LBP (or leg pain for those who underwent an ESI) coupled with a positive satisfaction rating (> 3 on a 5-point scale). Subjects who obtain a positive outcome at their initial 1-month follow-up visit will remain in the study and return for the final 3-month follow-up visit. Those with a negative outcome will exit the study "per protocol" to receive standard care, which may consist of other injections or non-rescue medications such as antidepressants and anticonvulsants. Subjects who obtain a positive outcome at 1-month but experience a recurrence before their 3-month follow-up visit will also exit the study per protocol, with their final outcome measures recorded before they receive standard care.
In those who receive ESI, a smaller parallel study will be done evaluating the association between allergies and outcome. Allergies will be categorized as immunologically based or not.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Epidural steroid injections | – | Procedure: Epidural steroid injectionPatients will receive a single interlaminar epidural steroid injection with 60 mg depomethylprednisolone, 1.5 ml of 0.25% bupivacaine and 1.5 ml of saline or a transforaminal epidural steroid injection with 60 mg depomethylprednisolone, 1.5 ml of 0.25% bupivacaine and 0.5 ml of saline. |
| Facet interventions | – | Procedure: Facet interventionPatients will receive diagnostic medial branch (facet joint nerve) blocks with 0.5 ml of 0.5% bupivacaine. If they experience a positive block (> 50% pain relief lasting more than 3 hours), they will then receive radiofrequency denervation. |
| Sacroiliac joint injections | – | Procedure: Sacroiliac joint injectionPatients will receive a single SI joint injection on the affected side(s) with 40 mg depomethylprednisolone and 2 ml of 0.5% bupivacaine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with low back or lumbar radicular pain scheduled for an injection
Key inclusion criteria (6 listed)
- Age > 18 years;
- Pain duration > 6 weeks;
- Low back pain presumed to be secondary to herniated disc or spinal stenosis (e.g. radiculopathy), facet joint pain or SI joint pain;
- For ESI, patients must have leg pain >/= 4/10 or comparable or greater than back pain, along with concordant MRI findings; for SI joint injections, patients must have tenderness overlying the SI joint; for facet joint pain, they must have paraspinal tenderness;
- Patient agrees to have ESI, facet blocks or SI joint injection for diagnostic or therapeutic purposes;
Key exclusion criteria (7 listed)
- Previous ESI, facet blocks or SI joint injection within the past 2 years;
- Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
- Previous surgery for ESI or facet block;
- Untreated coagulopathy;
- Allergy to contrast dye, bupivacaine or depomethylprednisolone;
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 |
|---|---|---|
| Facet interventionAlso: Medial branch block and radiofrequency ablationDiagnostic block of the nerves innervation the lumbar facet joint. If this block is positive (greater or equal to 50% relief), the participant will proceed to radiofrequency nerve ablation when the pain returns | Procedure or surgery | Facet interventions |
| Sacroiliac joint injectionInjection of steroid and local anesthetic into SI joint | Procedure or surgery | Sacroiliac joint injections |
| Epidural steroid injectionTransforaminal or interlaminar injection of steroid epidurally | Procedure or surgery | Epidural steroid injections |
Primary outcome
Mean reduction in average pain score
Time frame: 1 month
0-10 numerical rating scale for leg pain (ESI) or low back pain (facet procedure or sacroiliac joint injection). Higher scores indicate more pain.
16 secondary outcomes
Average back pain score
Time frame: 1 month
Average leg pain score
Time frame: 1 month
Worst back pain score
Time frame: 3 months
Worst leg pain score
Time frame: 3 months
Oswestry disability index score
Time frame: 1 month
Oswestry disability index score
Time frame: 3 months
Satisfaction score
Time frame: 1 month
Satisfaction score
Time frame: 3 months
Medication reduction
Time frame: 1 month
Medication reduction
Time frame: 3 months
Athens Insomnia Scale
Time frame: 1 month
Athens Insomnia Scale
Time frame: 3 months
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
Time frame: 1 month
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)
Time frame: 3 months
Positive outcome
Time frame: 1 month
Positive outcome
Time frame: 3 months
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 9 Dec 2021.
- Derived from this study: PubMed 34880117Cohen SP, Doshi TL, Kurihara C, Reece D, Dolomisiewicz E, Phillips CR, Dawson T, Jamison D, Young R, Pasquina PF. Multicenter study evaluating factors associated with treatment outcome for low back pain injections. Reg Anesth Pain Med. 2022 Feb;47(2):89-99. doi: 10.1136/rapm-2021-103247. Epub 2021 Dec 8.
- Derived from this study: PubMed 32701541Cohen SP, Doshi TL, Kurihara C, Dolomisiewicz E, Liu RC, Dawson TC, Hager N, Durbhakula S, Verdun AV, Hodgson JA, Pasquina PF. Waddell (Nonorganic) Signs and Their Association With Interventional Treatment Outcomes for Low Back Pain. Anesth Analg. 2021 Mar 1;132(3):639-651. doi: 10.1213/ANE.0000000000005054.
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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.
Steven P Cohen, MD principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain and Lumbar Radiculopathy, run by Johns Hopkins 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 6 inclusion and 7 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 9 Dec 2021. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Mean reduction in average pain score (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02329951, which also lists 2 linked publications.
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 9 Dec 2021.