Injections for Back Pain

(AEOUI2 Trial)

Overseen By William E Rivers, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Middle Tennessee Research Institute

Must not be taking: Opioids

Disqualifiers: Opioid use, Spine condition, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 7

Duration: 1 day

33 Participants Needed

Trial Summary

What is the purpose of this trial?

This study will study pain relief after spine injections that are used to guide care. Some improvements in pain from a procedure might be from placebo effect rather than the physiological effect of the procedure. The study will use naloxone to reverse the effect of the body's internal placebo system after a spine injection, so the placebo effect and the injection effect can be measured separately. This process may improve the understanding of spine injections and their ability to guide pain care.

Research Team

William E Rivers, DO

Principal Investigator

Tennessee Valley Healthcare System VA

Eligibility Criteria

This trial is for English-speaking adults who've had low back pain for at least 3 months, with a pain intensity of ≥4/10 despite treatment like physical therapy and medication. They must understand the study and be able to follow its procedures.

Inclusion Criteria

I understand English and can follow study procedures.

I have had low back pain for over 3 months and treatments like physical therapy haven't helped.

My average low back pain score is 4 or more out of 10.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo lumbar medial branch block followed by saline and naloxone infusions to assess placebo and nerve block effects

1 day

1 visit (in-person)

Follow-up

Participants are monitored for changes in pain scores and procedural outcomes after lumbar medial branch radiofrequency neurotomy

6 months

Multiple visits (in-person) at baseline, 6 weeks, 3 months, and 6 months

Treatment Details

Interventions

• Naloxone

Trial Overview The study tests if naloxone can block the body's placebo response after spine injections, separating the true physiological effect from any placebo effect. This could help better understand how spine injections manage pain.

Participant Groups

Group I: Single arm study: endogenous opioid blockade Experimental Treatment 2 Interventions

This is a single group study. The participants will undergo two sequential experimental conditions: saline infusion and naloxone infusion. Participants will be identified as candidates for standard of care lumbar medial branch block, consented, and enrolled. Baseline demographics and patient reported clinical measures will be collected. All participants will have IV placed, undergo standard of care lumbar medial branch block, wait 20 minutes, then have their response to procedure assessed. Then normal saline will be infused through the IV over several minutes, 10 minutes will pass, and response to procedure re-assessed. Then naloxone will be infused through the IV over several minutes, 10 minutes will pass, and response to procedure re-assessed for a final time. IV will then be removed. Participants will then follow standard of care clinical practice for second lumbar medial branch block and lumbar medial branch radiofrequency neurotomy treatment.

Who Is Running the Clinical Trial?

Middle Tennessee Research Institute

Lead Sponsor

Trials

2

Recruited

200+

International Pain and Spine Intervention Society

Collaborator

Trials

1

Recruited

30+