Auriculotherapy for Low Back Pain
(ATNI Trial)
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?
Is auriculotherapy safe for humans?
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.12348
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either real or sham cryo-auriculotherapy treatment, with follow-up imaging 5-7 days later
Washout
A 2-month washout period before crossover to the alternate treatment
Crossover Treatment
Participants receive the alternate treatment (sham or real cryo-auriculotherapy), with follow-up imaging 5-7 days later
Follow-up
Participants are monitored for safety and effectiveness after treatment
Treatment Details
Interventions
- AuriculoTherapy
Find a Clinic Near You
Who Is Running the Clinical Trial?
Keith M Vogt
Lead Sponsor