Changes in pain, mood, and functional connectivity following cryo-auriculotherapy in adults with chronic refractory low back pain: An open-label preliminary study

Abstract

Introduction This report describes the effects of auriculotherapy (AT) using cryogenic needles in a small cohort of chronic low back pain patients.

Methods The effects of AT on pain, mood, and functioning were recorded in 10 patients with chronic back pain before and after cryogenic AT using patient-reported outcome instruments: Brief Pain Inventory (BPI), Patient Health Questionnaire (PHQ-9), General Anxiety Disorder (GAD-7), and Patient-Reported Outcomes Measurement Information System (PROMIS-29). In addition, resting-state MRI data collected before and 5-7 days after AT treatment were analyzed for changes in functional connectivity in 4 patients.

Results GAD-7 scores decreased from 10.0 to 7.7 (95% confidence interval of difference= 0.2 – 4.4, p=0.036). Other patient-reported outcomes showed non-significant differences in this pilot cohort. Significant functional MRI connectivity changes were observed in 4 patients, suggesting that AT affected areas of the brain involved in pain processing.

Conclusion Cryogenic AT is a technique that may reduce the psychological burden of low back pain, but further study is needed. Preliminary functional connectivity changes support the concept that the effect of AT is centrally mediated.

Competing Interest Statement

The authors have declared no competing interest.

Clinical Trial

NCT06358287

Funding Statement

This study was funded by a seed grant from the Department of Anesthesiology and Perioperative Medicine, University of Pittsburgh

Author Declarations

I confirm all relevant ethical guidelines have been followed, and any necessary IRB and/or ethics committee approvals have been obtained.

Yes

The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The IRB of the University of Pittsburgh gave ethical approval for this work.

I confirm that all necessary patient/participant consent has been obtained and the appropriate institutional forms have been archived, and that any patient/participant/sample identifiers included were not known to anyone (e.g., hospital staff, patients or participants themselves) outside the research group so cannot be used to identify individuals.

Yes

I understand that all clinical trials and any other prospective interventional studies must be registered with an ICMJE-approved registry, such as ClinicalTrials.gov. I confirm that any such study reported in the manuscript has been registered and the trial registration ID is provided (note: if posting a prospective study registered retrospectively, please provide a statement in the trial ID field explaining why the study was not registered in advance).

Yes

I have followed all appropriate research reporting guidelines, such as any relevant EQUATOR Network research reporting checklist(s) and other pertinent material, if applicable.

Yes

Data Availability

All data produced in the present study are available upon reasonable request to the authors.

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