The Efficacy and Feasibility of an Interoceptive Exposure Technique for Preventing the Transition From Subacute to Chronic Back Pain by Altering the Emotional Response to Pain: Protocol for a Pilot Randomized Controlled Trial.

Background: Psychological factors such as stress, anxiety, mood, emotions, cognitive functioning, and pain behavior are relevant to the onset of pain and its continuation in the transition to chronic conditions. Subacute low back pain (LBP), a precursor to chronic LBP, is particularly poorly understood, and its relationships with psychological factors are understudied.

Objective: We will conduct a study aiming to prevent the chronicity of subacute LBP by altering the emotional response to pain using an interoceptive exposure technique (IET). Considering the recent increase in knowledge about psychological risk factors, as well as recent findings in cognitive neuroscience regarding emotional and cognitive background factors in the LBP chronicity process, efforts should be made to discover effective preventive methods.

Methods: We present a novel method aiming to prevent the transition from subacute to chronic back pain by altering the emotional response to pain using an IET. In this pilot randomized controlled trial, participants who are at a higher risk of LBP chronification due to the presence of a biomarker (ie, functional connectivity between the medial prefrontal cortex and nucleus accumbens) will be randomly assigned to the IET intervention group or control group A (treatment as usual). Participants who do not present with the biomarker will be assigned to control group B (treatment as usual) to assess how well this biomarker predicts the chronification of subacute LBP in this study population. Questionnaires measuring the pain experience and psychological distress will be used before the intervention, after the intervention (at 3 months), and at the 12-month follow-up.

Results: This research project will combine 2 novel methods: a biomarker as the inclusion criterion and an IET as the intervention. The comparative study design enables evaluation of the efficacy of the IET, as well as replication of the biomarker's validity as a possible clinical screening method.

Conclusions: If found to be useful, the IET would offer a cost-effective and reasonable way to develop treatment for acute and subacute back pain conditions. Potential benefits include increased pain management and quality of life for the individual patient with the addition of a potentially useful functional pain management method at the societal level.

Trial Registration: ClinicalTrials.gov NCT05450263; https://clinicaltrials.gov/ct2/show/NCT05450263.

International Registered Report Identifier (irrid): PRR1-10.2196/45701.