Yoga for Chronic Low Back Pain: A Type 1 Hybrid Implementation-Effectiveness Pragmatic Randomized Control Trial in the Cleveland Clinic Employee Health Plan

The investigators will use a single (investigators) blinded two-arm randomized control trial (RCT) design. The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase followed by a 12-week Follow-up Phase. Participants will be randomized 1:1 into weekly virtual yoga classes (Yoga Now group) or a wait-list control (Yoga Later group) who will receive usual care. After the 24 week study period, participants in the Yoga Later Group will be offered the yoga intervention in a non-study format as well as a free yoga mat and access to online yoga for LBP videos.

The screening and enrollment process will all occur remotely and involves the following: 1) A telephone or Information Technology approved, The Health Insurance Portability and Accountability Act (HIPAA-secure), virtual meeting platform where participants provide consent for completion of eligibility screening through a standardized questionnaire; 2) if eligible, provision of information about the study presented by study personnel with use of an Institutional Review Board approved information page for informed consent, answering all questions about the study, and assuring participant understanding through the "teach back" method.

Randomization occurs after administering the baseline survey. Investigators will use a computerized randomization procedure built into the study management system, RedCap, to randomize each enrolled participant using a 1:1 ratio to the Yoga Now group or Yoga Later group. Permuted variably-sized block randomization with block sizes of 6, 12 and 18 will be used.

The study interventions start within approximately one week of baseline data collection and randomization. Participants will be asked to complete questionnaire forms at baseline, weeks 6, 12 and 24. All participants throughout the entire 24-week study can continue to receive routine medical care including doctor visits and pain medication.

The hatha yoga intervention, a term for yoga that pairs poses and breathing techniques, is structured and reproducible. The full instructor manual and participant manual are available online. Originally, it was developed by an expert panel led by Rob Saper, MD and Master of Public Health (MPH) in 2007 and used in a pilot study of 30 participants with cLBP. It was further refined in 2011 in a dosing study of 95 participants and a larger non-inferiority trial of 320. It is designed specifically for the yoga-naïve individual for effectiveness and safety in cLBP. Each class is 75 minutes long and will be delivered virtually to a maximum class size of 12. Yoga instructors will complete an 8-hour training on the protocol directed by the Cleveland Clinic lead yoga instructor.