Predictive Factors for LBP Interventional Treatment Outcomes

NCT ID: NCT02329951

Last Updated: 2021-12-09

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 346 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-12-31
• Study Completion Date: 2021-12-31

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.

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

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Epidural steroid injection

Intervention Type: PROCEDURE

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.

Facet intervention

Intervention Type: PROCEDURE

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 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.

Sacroiliac joint injection

Intervention Type: PROCEDURE

Injection of steroid and local anesthetic into SI joint

Interventions

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

Intervention Type: PROCEDURE

Sacroiliac joint injection

Injection of steroid and local anesthetic into SI joint

Intervention Type: PROCEDURE

Epidural steroid injection

Transforaminal or interlaminar injection of steroid epidurally

Intervention Type: PROCEDURE

Other Intervention Names

Medial branch block and radiofrequency ablation

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Walter Reed National Military Medical Center

FED

Sponsor Role: collaborator

Landstuhl Regional Medical Center

FED

Sponsor Role: collaborator

Uniformed Services University of the Health Sciences

FED

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven P Cohen, MD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Locations

Johns Hopkins School of Medicine

Baltimore, Maryland, United States

Countries

United States

References

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.

Reference Type: DERIVED

PMID: 34880117 (View on PubMed)

Cohen 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.

Reference Type: DERIVED

PMID: 32701541 (View on PubMed)

Other Identifiers

IRB00050132

Identifier Type: -

Identifier Source: org_study_id