Auriculotherapy for Low Back Pain

(ATNI Trial)

Overseen By Amy Monroe, MPH, MBA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Keith M Vogt

Must not be taking: Marijuana, Opioids, Antidepressants, others

Disqualifiers: Ear neuropathy, Recent surgery, Cold diseases, others

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

Compensation: Varies

Number of Visits: 4

Duration: 5-7 days

60 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines how auriculotherapy, which uses a cold jet on specific ear points, might relieve low back pain. Researchers aim to understand the brain's response to this treatment through brain imaging. Participants will receive either the actual treatment or a placebo to compare results. This trial suits individuals who have experienced daily low back pain for at least six months. As an unphased trial, it provides a unique opportunity to contribute to innovative research that could lead to new pain relief methods.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, if you have started a new pain or mood-related medication in the last month, you may not be eligible to participate.

What prior data suggests that this auriculotherapy technique is safe for low back pain patients?

Research has shown that auriculotherapy, which involves stimulating points on the ear, is generally safe. Studies have found that most people tolerate this treatment well. The most common side effects are mild and may include temporary discomfort or redness at the stimulation site. This study uses cryo-auriculotherapy, employing a cold, focused jet instead of needles, making it less invasive. This method is expected to be even more comfortable for participants. Overall, evidence suggests that auriculotherapy is a safe option for managing pain, such as chronic low back pain. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about auriculotherapy for low back pain because it offers a non-invasive alternative to traditional treatments like medications or surgery. Unlike standard approaches that often rely on painkillers, auriculotherapy uses cryo-stimulation of the ear's surface to potentially influence pain pathways in the body. This method is unique as it targets specific points on the ear to alleviate pain, reducing reliance on pharmaceuticals and their side effects. Additionally, auriculotherapy could provide faster relief, with notable effects expected in just a few days, making it a promising option for those seeking quicker and potentially safer pain management solutions.

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

This trial will compare the effects of active cryo-auriculotherapy with sham interventions for low back pain. Studies have shown that auriculotherapy, similar to acupuncture but focused on the ear, can significantly reduce chronic low back pain. Research indicates that auriculotherapy can quickly lessen pain, often within 12 weeks. Many studies confirm its effectiveness, especially in adults with ongoing back pain. Some reports even mention improvements in mood and brain function along with pain relief. Overall, auriculotherapy appears promising for those dealing with persistent low back pain. ^{3 6 7 8 9}

Who Is on the Research Team?

Keith M Vogt, MD, PhD

Principal Investigator

University of Pittsburgh, UPMC

Are You a Good Fit for This Trial?

This trial is for individuals who have been experiencing low back pain for at least six months. Participants should be available for four study visits, with two sets of visits before and after treatment. Specific details about inclusion or exclusion criteria are not provided.

Inclusion Criteria

I experience daily chronic low back pain for over 6 months, averaging a pain score of at least 3 out of 10.

Exclusion Criteria

I do not have chronic pain in my shoulder or thumb.

Recent (<3 months) illicit drug use

I do not have conditions worsened by cold, such as Raynaud's or autoimmune diseases.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either real or sham cryo-auriculotherapy treatment, with follow-up imaging 5-7 days later

5-7 days

2 visits (in-person)

Washout

A 2-month washout period before crossover to the alternate treatment

2 months

Crossover Treatment

Participants receive the alternate treatment (sham or real cryo-auriculotherapy), with follow-up imaging 5-7 days later

5-7 days

2 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• AuriculoTherapy

Trial Overview The study is testing the effects of auriculotherapy, a non-invasive ear stimulation similar to acupuncture, on low back pain relief. It uses a cryo-IQ device that applies cold jets to specific ear areas. The effectiveness will be assessed using brain imaging before and after real or sham treatments.

How Is the Trial Designed?

Group I: Sham first / active cryo-auriculotherapy second Experimental Treatment 3 Interventions

Participants randomly assigned to Group 2 will receive sham auricular intervention first, at the end of visit 1. They will return 5-7 days later for follow-up imaging (visit 2). After at least a 2 month wash-out period, all will return for their third visit, which ends with verum cryo-auriculotherapy treatment. Visit 4 is the second follow-up imaging session. All visits involve fNIRS imaging with auricular stimulation using von Frey filaments, prior to sham/cryo intervention.

Group II: Active cryo-auriculotherapy first / sham second Experimental Treatment 3 Interventions

Participants randomly assigned to Group 1 will receive verum cryo-auriculotherapy treatment first, at the end of visit 1. They will return 5-7 days later for follow-up imaging (visit 2). After at least a 2 month wash-out period, all will return for their third visit, which will end with sham auricular intervention. Visit 4 is the second follow-up imaging session. All visits involve fNIRS imaging with auricular stimulation using von Frey filaments, prior to sham/cryo intervention.

Who Is Running the Clinical Trial?

Keith M Vogt

Lead Sponsor

Trials

4

Recruited

210+

Published Research Related to This Trial

A systematic review of various studies found that adverse events from auricular therapy (AT) are generally mild and transient, with common issues including tenderness, dizziness, and local discomfort, but no serious adverse events were reported.

The study highlights the need for improved reporting of adverse events in future AT research, suggesting that while AT appears to be a safe treatment option, more comprehensive data collection is necessary to ensure patient safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. Tan, JY., Molassiotis, A., Wang, T., et al.[2022]

A systematic review of 15 studies found that auricular acupuncture was effective in reducing pain intensity in chronic back pain patients, with positive results in 80% of the studies analyzed.

Despite its effectiveness, there is a lack of standardized protocols for applying auricular acupuncture, highlighting the need for more consistent methods in future research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for chronic back pain in adults: a systematic review and metanalysis. Moura, CC., Chaves, ECL., Cardoso, ACLR., et al.[2022]

Auriculotherapy is more effective than traditional western medications, conventional acupuncture, and Chinese herbal medicine in treating insomnia, with a significant improvement in sleep quality as measured by the Pittsburgh Sleep Quality Index (PSQI).

This therapy also has fewer adverse effects compared to western medications, suggesting it may be a safer alternative for insomnia treatment, although further high-quality studies are needed to confirm these findings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Systematic review and Meta-analysis on the auriculotherapy in treatment of insomnia]. Jiao, Y., Han, Y., Zhou, JC., et al.[2023]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5539928/

Efficacy of Auricular Acupressure for Chronic Low Back Pain Specifically, for the chronic back pain intensity, results of meta-analyses show that AA has a large immediate effect in reducing pain within 12 weeks and also ...

2. academic.oup.com academic.oup.com/painmedicine/article/26/9/515/8098058

Auricular point acupressure for older adults with chronic low ... Efficacious modalities are limited in chronic low back pain (cLBP). We determined the efficacy of auricular point acupressure (APA) in older ...

3. digitalcommons.wustl.edu digitalcommons.wustl.edu/cgi/viewcontent.cgi?article=2112&context=open_access_pubs

Auricular point acupressure for chronic low back pain Higher scores indicated that patients had higher pain intensity. For data analysis, the score for each outcome variable was standardized so that each outcome.

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/32243410/

Effect of auriculotherapy on chronic low back pain Many trials have shown that auriculotherapy (AT) can effectively treat CLBP. There are currently no systematic reviews of this therapy.

5. medrxiv.org medrxiv.org/content/10.1101/2024.05.17.24301837v1.full.pdf

Changes in pain, mood, and functional connectivity ... Abstract: Introduction: This report describes the effects of auriculotherapy (AT) using cryogenic needles in a small cohort of chronic low back pain patients.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC4241563/

Adverse Events of Auricular Therapy: A Systematic Review Our findings provide preliminary evidence that AT is a relatively safe approach in routine practice. The most frequently reported adverse events were mainly ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7440161/

Effect of auriculotherapy on chronic low back pain Many trials have shown that auriculotherapy (AT) can effectively treat CLBP. There are currently no systematic reviews of this therapy.

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S1744388106000892

Auriculotherapy on low back pain in the elderly The objective of the study was to examine the effectiveness of auriculotherapy using magnetic pellets for the elderly suffering from low back pain (LBP).

9. mdpi.com mdpi.com/1660-4601/20/3/1705

The Effects of Auricular Acupressure on Low Back Pain ... We conclude that AA is an effective, safe, cost-effective, non-invasive nursing intervention that can improve pain, neuropathy, and sleep in patients on PSPS.