A Study to Evaluate Performance Outcomes Following Interventional Treatment of Axial Low Back Pain

Overview

About this study

The purpose of this study is to determine if intra-articular lumbar facet and sacroiliac joint injections, or lumbar radiofrequency ablation (RFA) are effective in improving 1) patient-reported measures of pain, function and quality of life; 2) capacity; and 3) performance as measured by change in activity counts.  Secondarily, the value of measuring capacity and performance following diagnostic medial branch blocks as a predictor of successful outcomes after lumbar RFA will be explored. 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

  • Patients between the ages of 18 and 85.
  • Scheduled to undergo lumbar facet joint intra-articular injection, lumbar diagnostic medial branch block, lumbar facet RFA, or SIJ intra-articular injection.
  • Have a visual analog scale pain score of 4 or higher.

Exclusion Criteria: 

  • Patients who have leg pain that is worse than their back pain
  • Are currently incarcerated.
  • Are non-English speaking.
  • Are unable to understand or operate the accelerometer device.
  • Have any comorbid condition that significantly limits walking such as severe cardiopulmonary disease, prior stroke or pregnancy. 
  • Patients currently scheduled for spine surgery or who have a current diagnosis of cancer that is believed to be contributing to their spine pain.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Jacksonville, Fla.

Mayo Clinic principal investigator

Paul Scholten, M.D.

Open for enrollment

Contact information:

Paul Scholten M.D.

(904) 953-2823

Scholten.Paul@mayo.edu

More information

Publications

Publications are currently not available

Study Results Summary

Not yet available

Supplemental Study Information

Not yet available

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CLS-20515738

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