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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine the effectiveness of spine injections in relieving back pain by distinguishing actual pain relief from the placebo effect. Participants will receive a standard back injection, followed by saline and naloxone infusions. Naloxone, a medication typically used to block opioid effects, will help measure differences in pain relief. The trial is best suited for individuals who have experienced low back pain for over three months, have not found relief with physical therapy or medication, and report a pain level of 4 or higher on a 10-point scale. As a Phase 4 trial, this research involves an FDA-approved treatment and seeks to understand how it can benefit more patients.

Do I need to stop my current medications for the trial?

The trial does not specify if you need to stop your current medications, but you cannot use opioid medications daily or within 3 days before participating. If you use opioids as needed, you must stop them 3 days before the trial.

What is the safety track record for naloxone?

Research has shown that naloxone, a treatment used in this study, is generally safe for people. Previous studies found that combining naloxone with oxycodone effectively manages chronic low back pain and is usually well-tolerated, meaning most people can use it without major problems.

Naloxone is often used in hospitals to counteract opioid effects, which demonstrates its safety. Reports indicate a higher risk of opioid overdose after naloxone is prescribed, but this mainly concerns opioid users, not participants in studies like this one. Overall, naloxone appears to be a safe option for people in this study. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Naloxone is unique because, unlike typical back pain treatments that often rely on medications like NSAIDs or opioids to manage pain, it works by blocking the effects of endogenous opioids in the body. Researchers are excited about this approach because it could provide insights into how much the body's own pain management system contributes to back pain relief. This study aims to understand whether targeting the body's natural opioid activity can be an effective way to alleviate back pain, potentially offering a new avenue for treatment without the risk of opioid dependency.

What evidence suggests that naloxone might be an effective treatment for back pain?

This trial will investigate the effects of naloxone on back pain. Research has shown that naloxone helps by blocking certain brain pathways used by opioids, aiding in pain management. While naloxone has potential in managing pain when used correctly, opioids might not always be the best option for short-term back pain. In this trial, participants will receive a naloxone infusion to assess its impact on pain response. ^{1 3 6 7 8}

Who Is on the Research Team?

William E Rivers, DO

Principal Investigator

Tennessee Valley Healthcare System VA

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3718056/

Controlled-release oxycodone and naloxone in the treatment ... According to per-protocol analysis, CR oxycodone/CR naloxone resulted in significantly lower mean (± SD) pain scores measured on a visual analogue scale (48.6± ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S1526590008006445

Analgesic Efficacy and Safety of Oxycodone in ... For the full analysis population, oxycodone PR/naloxone PR was effective in reducing the risk of pain events, with an overall risk of 58% compared with placebo.

3. mdpi.com mdpi.com/2076-3417/15/19/10348

Beyond Oral Opioids? A Retrospective Comparison of ... Specifically, the significant reduction in pain intensity and the favorable tolerability profile observed in our cohort mirror the positive outcomes reported in ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/25942606/

Safety and efficacy of oxycodone/naloxone vs. ... The primary outcome was the percentage of patients without adverse event-related study discontinuations who presented with a combination of a ≥50% improvement ...

5. www1.racgp.org.au www1.racgp.org.au/newsgp/clinical/opioids-ineffective-for-acute-low-back-or-neck-pai

Opioids ineffective for acute low back or neck pain: Study This intervention reduced opioid prescribing from 63% to 51% of low back pain presentations. The reduction was sustained for 30 months. Key to ...

6. clinicaltrials.gov clinicaltrials.gov/ct2/show/nct01358526

NCT01358526 | Efficacy and Safety of Oxycodone/ ... The primary objective of this study is to assess the efficacy and safety of OXN compared to placebo in opioid-experienced subjects with moderate ...

7. catalogues.ema.europa.eu catalogues.ema.europa.eu/node/1256/methodological-aspects

Safety and efficacy of oxycodone/naloxone vs. oxycodone vs ... Safety and efficacy of oxycodone/naloxone vs. oxycodone vs. morphine in the treatment of chronic low back pain - a 12-week prospective ...

8. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/add.15643

Associations between naloxone prescribing and opioid ... Receiving a naloxone prescription appears to be associated with increased risk of subsequent opioid overdose among patients with acute and chronic pain.