Accepted for/Published in: JMIR Research Protocols
Date Submitted: Mar 17, 2023
Date Accepted: Sep 4, 2023
Preventing transition from subacute to chronic back pain by altering the emotional response to pain – a study protocol of a pilot study addressing the efficacy and feasibility of an interoceptive exposure technique.
ABSTRACT
Background:
Psychological factors like stress, anxiety, mood, emotions, cognitive functioning, and pain behaviour are relevant to the onset of pain and its continuation in the transition to chronic conditions. Sub-acute low back pain, a precursor to chronic low back pain (LBP), is particularly poorly understood and its relations with the psychological factors are understudied.
Objective:
Considering the recent increase of 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. Therefore, we will conduct a study aiming to prevent chronicity of subacute LBP by altering the emotional response to pain using an interoceptive exposure technique (IET).
Methods:
We present a novel method aiming to prevent transition from subacute to chronic back pain by altering the emotional response to pain using an IET. Subjects who are at a higher risk of LBP chronification due to the presence of a biomarker (i.e. 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). Subjects 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 consist of a pilot randomized controlled trial in which two novel methods will be combined: 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. This study will yield new valuable information about both the neural processes driving pain to chronicity and a specific and promising intervention to modulate that process. This study is funded by Orton research grants from the Ministry of Social Affairs and Health, Finland (A2500/483).
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 are 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. Clinical Trial: Clinical Trials.gov NCT05450263
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