Yoga for Chronic Low Back Pain in the Cleveland Clinic Employee Health Plan
Condition: Chronic Pain; Back Pain
MeSH terms: Back Pain; Low Back Pain; Chronic Pain
Study type: Interventional

Summary: 
      This study uses clinical trial and implementation science methodology to specifically assess
      the effectiveness of yoga into the management of chronic low back pain (cLBP) within the
      Cleveland Clinic Employee Health Plan. The study will use a type 1 hybrid
      effectiveness-implementation design, which tests a clinical intervention while collecting
      data on implementation. Studying and implementing evidence-based, non-pharmacologic
      interventions is an important strategy for improving pain management and reducing opioid use
      disorder.
    

Detailed description: 
      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.

      Class begins with a relaxation exercise, yoga breathing exercises, and a brief discussion of
      yoga philosophy. The class proceeds with warm-up yoga exercises and then yoga postures. Yoga
      breathing is emphasized throughout. The class ends with a relaxation exercise. The 12 weeks
      are divided into four 3-week segments. Each segment is given a theme (e.g., "Listening to the
      Wisdom of the Body"). Participants are frequently advised to go slowly and carefully. The
      degree of difficulty of postures learned increases with each segment. For each segment, the
      participants gradually learn a sequence of 12-15 poses. The protocol provides variations and
      uses various aids (e.g., chair, strap) to accommodate a range of physical abilities.
      Participants are strongly encouraged to practice at home for 30 minutes daily on days which
      they do not attend yoga class. To facilitate home practice, participants will be given a free
      yoga mat, participant manual, and provided access to online videos prepared by the study
      instructors.

      Ten percent of online yoga classes will be virtually observed and assessed by a study team
      member for instructor fidelity to the protocol using a checklist. A 12-week follow-up phase
      consisting of larger optional classes for maintenance will follow.
    

Intervention name(s): Yoga
Intervention type(s): Behavioral
Intervention description(s): The trial will be 24 weeks long and divided into two distinct parts: an initial 12-week Treatment Phase during which, yoga participants will receive a reproducible standardized weekly yoga intervention delivered virtually with additional resources for home practice, followed by a 12-week Follow-up Phase.
Other intervention name(s): Treatment Group; Yoga Now
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Investigators will use a single-blinded (investigator) 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) or a wait-list control (Yoga Later) who will receive usual care. After the 24 week study period, participants in Yoga Later will be offered the yoga intervention in a non-study format.
Masking: Single (Investigator)
Primary purpose: Treatment