Predictive Factors for LBP Interventional Treatment Outcomes

NCT02329951 | Completed

• 1 other identifier: IRB00050132
• Study Type: observational
• Target: 346
• Locations: 1 country
• Sites: 1

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.

Conditions

Low Back Pain; Lumbar Radiculopathy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (16)

• Average back pain score

  1 month

• Average leg pain score

  1 month

• Worst back pain score

  3 months

• Worst leg pain score

  3 months

• Oswestry disability index score

  1 month

Study Arms (3)

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

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

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

Interventions

Facet intervention 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

Also known as: Medial branch block and radiofrequency ablation

Facet interventions

Sacroiliac joint injection PROCEDURE

Injection of steroid and local anesthetic into SI joint

Sacroiliac joint injections

Epidural steroid injection PROCEDURE

Transforaminal or interlaminar injection of steroid epidurally

Epidural steroid injections

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Johns Hopkins University: lead
• Walter Reed National Military Medical Center: collaborator
• Landstuhl Regional Medical Center: collaborator
• Uniformed Services University of the Health Sciences: collaborator

Study Sites (1)

Johns Hopkins School of Medicine

Baltimore, Maryland, 21205, United States

Location

Related Publications (2)

• 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.

  PMID: 34880117 DERIVED

• 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.

  PMID: 32701541 DERIVED

MeSH Terms

Conditions

Low Back Pain; Radiculopathy

Interventions

Radiofrequency Ablation

Condition Hierarchy (Ancestors)

Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

Study Officials

• Steven P Cohen, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 30, 2014
• First Posted: January 1, 2015
• Study Start: December 1, 2014
• Primary Completion: May 1, 2021
• Study Completion: December 1, 2021
• Last Updated: December 9, 2021

Record last verified: 2021-05

Locations

US (1)