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Predictive Factors for LBP Interventional Treatment Outcomes

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ClinicalTrials.gov Identifier: NCT02329951
Recruitment Status : Recruiting
First Posted : January 1, 2015
Last Update Posted : July 15, 2020
Sponsor:
Collaborators:
Walter Reed National Military Medical Center
Landstuhl Regional Medical Center
Uniformed Services University of the Health Sciences
Information provided by (Responsible Party):
Johns Hopkins University

Brief 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 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.

Condition or disease Intervention/treatment
Low Back Pain Lumbar Radiculopathy Procedure: Facet intervention Procedure: Sacroiliac joint injection Procedure: Epidural steroid injection

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.

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Study Type : Observational
Estimated Enrollment : 346 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective, Observational Study Evaluating the Ability of Clinical Factors to Predict Interventional Treatment Outcomes for Low Back Pain (LBP)
Study Start Date : December 2014
Estimated Primary Completion Date : March 2021
Estimated Study Completion Date : October 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Back Pain

Group/Cohort Intervention/treatment
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.
Procedure: Epidural steroid injection
Transforaminal or interlaminar injection of steroid epidurally

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.
Procedure: Facet intervention
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
Other Name: Medial branch block and radiofrequency ablation

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.
Procedure: Sacroiliac joint injection
Injection of steroid and local anesthetic into SI joint




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Average back pain score [ Time Frame: 1 month ]
    0-10 numerical rating scale for back pain. Higher scores indicate more pain.

  2. Average leg pain score [ Time Frame: 1 month ]
    0-10 numerical rating scale for leg pain for ESI only. Higher scores indicate more pain.

  3. Worst back pain score [ Time Frame: 3 months ]
    0-10 numerical rating scale for back pain. Higher scores indicate more pain.

  4. Worst leg pain score [ Time Frame: 3 months ]
    0-10 numerical rating scale for leg pain ESI only. Higher scores indicate more pain.

  5. Oswestry disability index score [ Time Frame: 1 month ]
    0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)

  6. Oswestry disability index score [ Time Frame: 3 months ]
    0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)

  7. Satisfaction score [ Time Frame: 1 month ]
    5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)

  8. Satisfaction score [ Time Frame: 3 months ]
    5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)

  9. Medication reduction [ Time Frame: 1 month ]
    Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)

  10. Medication reduction [ Time Frame: 3 months ]
    Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)

  11. Athens Insomnia Scale [ Time Frame: 1 month ]
    0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)

  12. Athens Insomnia Scale [ Time Frame: 3 months ]
    0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)

  13. Quick Inventory of Depressive Symptomatology (QIDS-SR 16) [ Time Frame: 1 month ]
    0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)

  14. Quick Inventory of Depressive Symptomatology (QIDS-SR 16) [ Time Frame: 3 months ]
    0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)

  15. Positive outcome [ Time Frame: 1 month ]
    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.

  16. Positive outcome [ Time Frame: 3 months ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Adult patients with low back or lumbar radicular pain scheduled for an injection
Criteria

Inclusion Criteria:

  1. Age > 18 years;
  2. Pain duration > 6 weeks;
  3. Low back pain presumed to be secondary to herniated disc or spinal stenosis (e.g. radiculopathy), facet joint pain or SI joint pain;
  4. 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;
  5. Patient agrees to have ESI, facet blocks or SI joint injection for diagnostic or therapeutic purposes;
  6. Average pain score >/= 4/10 over the past week

Exclusion Criteria:

  1. Previous ESI, facet blocks or SI joint injection within the past 2 years;
  2. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
  3. Previous surgery for ESI or facet block;
  4. Untreated coagulopathy;
  5. Allergy to contrast dye, bupivacaine or depomethylprednisolone;
  6. Pregnancy;
  7. Cannot read or understand English.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02329951


Contacts
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Contact: Steven P Cohen, MD 410-955-1818 scohen40@jhmi.edu
Contact: Connie Kurihara, RN 301-400-2595 conniekurihara@gmail.com

Locations
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United States, Maryland
Johns Hopkins School of Medicine Recruiting
Baltimore, Maryland, United States, 21205
Contact: Steven P Cohen, MD    410-955-1818    scohen40@jhmi.edu   
Sponsors and Collaborators
Johns Hopkins University
Walter Reed National Military Medical Center
Landstuhl Regional Medical Center
Uniformed Services University of the Health Sciences
Investigators
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Principal Investigator: Steven P Cohen, MD Johns Hopkins University
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT02329951    
Other Study ID Numbers: IRB00050132
First Posted: January 1, 2015    Key Record Dates
Last Update Posted: July 15, 2020
Last Verified: July 2020
Additional relevant MeSH terms:
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Radiculopathy
Back Pain
Low Back Pain
Pain
Neurologic Manifestations
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases