Virtual Tai Chi for Chronic Low Back Pain (Spine 2027)

Disability (ODI v2.1a) ODI: Oswestry Disability Index

Change in Oswestry Disability Index total from baseline to 3 months. Time Frame: T0 to T3. Co-primary with BPI-4; both must reach significance. The Oswestry Disability Index version 2.1a (ODI) is a 10-item self-report questionnaire assessing back pain related disability across pain intensity, personal care, lifting, walking, sitting, standing, sleeping, sex life, social life, and travelling. Each item is scored 0 to 5 and the total is converted to a percentage. Scores range from 0 to 100 percent, with higher scores indicating greater disability, so a decrease in score is a better outcome. Proportional scoring is applied when items are missing, per standard ODI version 2.1a scoring. This outcome is the change in ODI total score from baseline to 3 months. It is co-primary with the Brief Pain Inventory Short Form 4-item pain severity subscale (BPI-4); both must reach statistical significance to claim treatment effectiveness.

Pain severity (BPI-4) BPI-4: Brief Pain Inventory Short Form, 4-item pain severity subscale

Change in Brief Pain Inventory 4-item average from baseline to 3 months. Time Frame: T0 to T3. The Brief Pain Inventory Short Form (BPI) 4-item pain severity subscale asks participants to rate their pain at its worst, at its least, on average, and right now during the past 7 days, each on a 0 to 10 numeric rating scale. The subscale score is the mean of the four items and ranges from 0 to 10, with higher scores indicating greater pain severity, so a decrease in score is a better outcome. This outcome is the change in BPI-4 score from baseline to 3 months. It is co-primary with the Oswestry Disability Index (ODI); both must reach statistical significance to claim treatment effectiveness.

Quality of life (EQ-5D-5L: EuroQol 5-Dimension 5-Level questionnaire)

EQ-5D-5L index; input to QALYs (QALY: quality-adjusted life year.) Time Frame: T0, T3, T6. The EuroQol 5-Dimension 5-Level questionnaire (EQ-5D-5L) measures health-related quality of life across five domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each domain has five response levels. Responses are converted into a single index score using the United States value set. Index scores range from -0.573 to 1.000, where 1.000 represents full health and 0 represents a health state judged equivalent to death; negative values represent health states judged worse than death. Higher scores indicate better health-related quality of life, so an increase in score is a better outcome. The index score is also the input to the quality-adjusted life year (QALY) calculation, computed as area under the curve from baseline to 6 months.

Healthcare costs (RUQ: Resource Use Questionnaire)

Total costs from Resource Use Questionnaire (visits, procedures, imaging, medications). Time Frame: T0 to T6 .The Resource Use Questionnaire (RUQ) is a self-report instrument capturing healthcare utilization for back pain over the prior 3 months, including provider visits, procedures, imaging, and medications. It is adapted from previously funded studies and aligned with the Database of Instruments for Resource Use Measurement (DIRUM) framework. The RUQ is not a scored scale; it records counts of services used. Reported utilization is multiplied by standard unit costs to produce total healthcare costs, reported in United States dollars, accumulated from baseline through 6 months. The theoretical minimum is $0 and there is no upper bound. Lower total costs indicate a better outcome from the health system perspective

Work productivity (WPAI-SHP: Work Productivity and Activity Impairment Questionnaire, Specific Health Problem version)

Productivity loss and activity impairment. Time Frame: T0 to T6. The Work Productivity and Activity Impairment Questionnaire, Specific Health Problem version (WPAI-SHP) is a six-item self-report instrument assessing the effect of a specified health problem, in this study chronic low back pain, on work and on regular daily activities during the past 7 days. Standard scoring converts responses into impairment percentages ranging from 0 to 100 percent, with higher percentages indicating greater impairment, so a decrease is a better outcome. The score reported for this outcome measure is total work productivity impairment, which combines work time missed because of back pain (absenteeism) with impairment experienced while working (presenteeism), and is calculated for participants who are employed. Activity impairment, which is calculated for all participants regardless of employment status, is collected on the same instrument and used as a secondary input to the employer-perspective econo

Cost-effectiveness (ICER: incremental cost-effectiveness ratio)

Incremental cost per QALY gained. Time Frame: T0 to T6.

Surgery, procedures, imaging

Incident and scheduled spine surgery; epidural injections, ablations, MRI, CT, X-ray. Time Frame: through T6 (T12 for treatment).

Medication use

Self-reported changes in OTC and prescription pain medication. Time Frame: T2, T3, T6 (T12 treatment).

Pain responder / recovery

Proportion with \>=30% BPI reduction; recovery (average pain \<=1/10). Time Frame: T3, T6.

Qualitative experience

Semi-structured interviews. Time Frame: T3 and T6. Semi-structured qualitative interviews will be conducted with up to 20 participants by telephone or Zoom, lasting approximately 30 to 60 minutes each and audio-recorded with participant consent. Up to 10 participants who discontinue will be invited to interview separately. Interviews explore participant experience of the virtually delivered tai chi program, including perceived benefit, barriers to home practice, and acceptability of virtual delivery. This is a qualitative outcome measure. It is not scored on a scale, and no minimum or maximum values or direction of benefit apply. Interview transcripts will be analyzed thematically, and results will be reported as the themes identified and the number of participants contributing to each theme.