Abstract
BackgroundSpinal fusion surgery is associated with severe acute postsurgical pain and high rates of chronic postsurgical pain in adolescents. Psychological distress, sleep disturbance, and low pain self-efficacy predict higher acute pain and likelihood of developing chronic postsurgical pain. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs. education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery.MethodsAdolescents 12–18 years of age undergoing spinal fusion for idiopathic conditions, and their parent, will be recruited from pediatric centers across the USA, for a target complete sample of 400 dyads. Adolescents will be randomized into 4 study arms using a factorial design to SurgeryPalTM or education control during 2 phases of treatment: (1) pre-operative phase (one-month before surgery) and (2) post-operative phase (1 month after surgery). Acute pain severity and interference (primary acute outcomes) and opioid use will be assessed daily for 14 days following hospital discharge. Chronic pain severity and interference (primary acute outcomes), as well as HRQL, parent and adolescent distress, sleep quality, and opioid use/misuse (secondary outcomes), will be assessed at 3 months and 6 months post-surgery.DiscussionDemonstration of effectiveness and understanding optimal timing of perioperative intervention will enable implementation of this scalable psychosocial intervention into perioperative care. Ultimately, the goal is to improve pain outcomes and reduce reliance on opioids in adolescents after spine surgery.Trial registrationNCT04637802 ClinicalTrials.gov. Registered on November 20, 2020
Highlights
Spinal fusion surgery is one of the most frequently performed major musculoskeletal surgeries in children and adolescents, with an estimated 12,600 procedures performed in the USA annually [1]
Adolescents who experience severe acute postsurgical pain are at elevated risk for developing chronic postsurgical pain (CPSP), a condition marked by chronic pain which impacts healthrelated quality of life (HRQL) after surgery [14]
This study will address a critical gap in knowledge of perioperative interventions targeting psychosocial risk factors to prevent transition from acute to CPSP in adolescents undergoing spinal fusion surgery
Summary
Background and rationale Spinal fusion surgery is one of the most frequently performed major musculoskeletal surgeries in children and adolescents, with an estimated 12,600 procedures performed in the USA annually [1]. Interventions targeting baseline psychosocial risk factors may reduce acute postoperative pain and have potential to interrupt a negative trajectory of continued pain and poor health outcomes. Interventions targeting baseline psychosocial risk factors have potential to interrupt a negative trajectory of continued pain and poor health-related quality of life (HRQL) over time but have not yet been developed and evaluated. This randomized controlled trial will test effectiveness of a digital peri-operative cognitive-behavioral intervention (SurgeryPalTM) vs education-control delivered to adolescents and their parents to improve acute and chronic pain and health outcomes in adolescents undergoing spine surgery
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