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

Trial Summary

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 data supports the effectiveness of the treatment AuriculoTherapy for low back pain?

Research shows that auriculotherapy, including techniques like laser auriculotherapy and auricular acupuncture, can help reduce chronic spinal and musculoskeletal pain, which suggests it may also be effective for low back pain. ^{1 2 3 4 5}

Is auriculotherapy safe for humans?

Research shows that auriculotherapy is generally safe for humans, with most side effects being mild and temporary, such as tenderness, dizziness, and minor skin irritation. No serious adverse events have been identified. ^{1 2 3 6 7}

How is auriculotherapy different from other treatments for low back pain?

Auriculotherapy is unique because it involves stimulating specific points on the outer ear that correspond to different parts of the body, which is different from traditional treatments like medication or physical therapy. This method can be used as an additional option to help manage chronic low back pain, especially when combined with exercise. ^{1 2 3 4 8}

What is the purpose of this trial?

This is a clinical study of patients who have low back pain (for at least 6 months). The goal is to understand, with brain imaging, how auriculotherapy (an acupuncture-like stimulation of the ear) may work to relieve pain. There are 4 total study visits, divided into two pairs of visits that occur before and 5-7 days after receiving either a real or sham auriculotherapy treatment. The cryo-IQ device will be used, to stimulate 7 small areas on both ears with a focused jet of cold as a small amount of compressed gas is released. This is generally not painful, and less invasive, compared to using needles for auriculotherapy.

Research Team

Keith M Vogt, MD, PhD

Principal Investigator

University of Pittsburgh, UPMC

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Effects of low-power laser auriculotherapy on chronic spinal pain: Randomized clinical trial. [2022]

2. Brazil pubmed.ncbi.nlm.nih.gov

Auriculotherapy for reducing chronic spinal pain in health workers: a clinical trial. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Auricular therapy for chronic pain management in adults: A synthesis of evidence. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Auriculotherapy and reducing chronic musculoskeletal pain: integrative review. [2021]

5. Brazil pubmed.ncbi.nlm.nih.gov

Auricular acupuncture for chronic back pain in adults: a systematic review and metanalysis. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Adverse events of auricular therapy: a systematic review. [2022]

7. China pubmed.ncbi.nlm.nih.gov

[Systematic review and Meta-analysis on the auriculotherapy in treatment of insomnia]. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Exercise and manual auricular acupuncture: a pilot assessor-blind randomised controlled trial. (The acupuncture and personalised exercise programme (APEP) trial). [2021]