Predictive Factors for LBP Interventional Treatment Outcomes

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain; Lumbar Radiculopathy
• Intervention / Treatment: Procedure: Epidural steroid injection; Procedure: Facet intervention; Procedure: Sacroiliac joint 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.

• Study Type: Observational
• Enrollment (Actual): 346

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Baltimore, Maryland, United States, 21205
      • Johns Hopkins School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adult patients with low back or lumbar radicular pain scheduled for an injection

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

3

Cohorts and Interventions

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 Names: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 month

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	3 months
Average back pain score	0-10 numerical rating scale for back pain. Higher scores indicate more pain.	1 month
Average leg pain score	0-10 numerical rating scale for leg pain for ESI only. Higher scores indicate more pain.	1 month
Worst back pain score	0-10 numerical rating scale for back pain. Higher scores indicate more pain.	3 months
Worst leg pain score	0-10 numerical rating scale for leg pain ESI only. Higher scores indicate more pain.	3 months
Oswestry disability index score	0-100% score measuring function for back and/ leg pain (higher scores indicate worse function)	1 month
Satisfaction score	5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)	1 month
Satisfaction score	5-point Likert scale measuring satisfaction (higher scores indicate greater satisfaction)	3 months
Medication reduction	Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)	1 month
Medication reduction	Cessation of non-opioid analgesic or > 20% change in opioids (yes or no)	3 months
Athens Insomnia Scale	0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)	1 month
Athens Insomnia Scale	0-24 point scale measuring sleep quality (higher scores indicate greater sleep dysfunction)	3 months
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)	0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)	1 month
Quick Inventory of Depressive Symptomatology (QIDS-SR 16)	0-48 point scale measuring symptoms of depression (higher scores indicate greater depressive symptoms)	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.	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.	3 months

Collaborators and Investigators

• Sponsor: Johns Hopkins University
• Collaborators: Walter Reed National Military Medical Center; Uniformed Services University of the Health Sciences; Landstuhl Regional Medical Center

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2014
• Primary Completion (Actual): May 1, 2021
• Study Completion (Actual): December 1, 2021

Study Registration Dates

• First Submitted: December 30, 2014
• First Submitted That Met QC Criteria: December 30, 2014
• First Posted (Estimate): January 1, 2015

Study Record Updates

• Last Update Posted (Actual): December 9, 2021
• Last Update Submitted That Met QC Criteria: December 8, 2021
• Last Verified: May 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Radiculopathy
• Other Study ID Numbers: IRB00050132