Emotion Regulation as a Primary Mechanism of Action in Yoga Interventions for Chronic Low Back Pain: An RCT Testing Biological and Psychological Pathways (Preprint)

Abstract

Interventions that promote adaptive emotion regulation (ER) skills reduce pain in chronic pain patients; however, whether effects of yoga practice on chronic low back pain (CLBP) are due to improvements in ER remains to be examined.

This study will test whether yoga’s effects on CLBP (improved pain severity and interference) are mediated by improved ER, the extent to which effects are related to specific aspects of ER, and the role of pain sensitization as a mediator or moderator of effects.

We will enroll 204 adults with CLBP who will be randomized to receive the yoga (n=102) or a control stretching/strengthening (n=102) intervention, which are delivered via online synchronous biweekly 75-minute sessions over 12 weeks. Participants are encouraged to practice postures/exercises for 25 minutes on other days. Participants will be assessed at five timepoints: baseline, mid-intervention (6 weeks), post-intervention (12 weeks), and 3- and 6-month follow-ups. Assessments of emotion regulation, pain severity and interference, pain sensitivity including somatosensory and gene expression profiles, and physical strength/flexibility will be conducted at each visit.

The primary outcome will be the mean change in pain severity as measured by the Brief Pain Inventory-Short Form at 12 weeks. The primary mechanism of action is emotion regulation measured by change in the Difficulties in Emotion Regulation Scale (DERS) total score. Secondary outcomes include pain sensitivity, physical strength/flexibility, pain interference, and quality of life.

Data collection is ongoing and upon completion the analyses will be performed as described.

This study is registered on ClinicalTrials.gov with the number NCT04678297.