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Predictive Factors for LBP Interventional Treatment Outcomes

NCT02329951 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 346

Last updated 2021-12-09

No results posted yet for this study

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

Interventions

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

PROCEDURE

Sacroiliac joint injection

Injection of steroid and local anesthetic into SI joint

PROCEDURE

Epidural steroid injection

Transforaminal or interlaminar injection of steroid epidurally

Sponsors & Collaborators

  • Walter Reed National Military Medical Center

    collaborator FED

  • Landstuhl Regional Medical Center

    collaborator FED

  • Uniformed Services University of the Health Sciences

    collaborator FED

  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Steven P Cohen, MD · Johns Hopkins University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-12-31
Primary Completion
2021-05-31
Completion
2021-12-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02329951 on ClinicalTrials.gov