Persistent Relief: Protocol for a Feasibility Randomized Trial Comparing Yoga to Pain Education for Patients With...

Area of Science:

• Pain Management
• Integrative Medicine
• Clinical Trial Design

Background:

• Persistent post-surgical pain is a growing concern with limited treatment options.
• Non-pharmacological interventions like yoga show promise for chronic pain management.
• Rigorous studies on yoga for persistent post-surgical pain are lacking.

Purpose of the Study:

• To describe protocols for a pilot randomized controlled trial comparing yoga to chronic pain health education for persistent post-surgical pain.
• To present results from a modified Delphi process adapting a yoga program for this patient population.
• To inform future, fully powered studies on yoga's efficacy and underlying mechanisms in chronic pain.

Main Methods:

• A pilot randomized controlled trial (NCT06949007) involving 50 patients with persistent post-surgical pain.
• Comparison of a 12-week yoga program against a 12-week chronic pain health education program.
• Utilized a modified Delphi process with an expert panel to validate the yoga program adaptation.

Main Results:

• The yoga program was adapted and endorsed by an interdisciplinary expert panel.
• Feasibility and acceptability metrics are primary outcomes for this pilot study.
• Secondary outcomes include biopsychosocial measures, with the Brief Pain Inventory as a key clinical outcome.

Conclusions:

• Preliminary data will inform modifications for a future large-scale study on yoga's efficacy.
• Findings will guide research into the biological mechanisms of yoga in chronic pain.
• This study lays the groundwork for integrating yoga into persistent post-surgical pain management.