Chronic Low-back Pain (cLBP), Low Back Pain
Conditions
Keywords
tai chi, qigong, meditation, mind-body, virtual care, telehealth, disability, quality of life, cost-effectiveness, non-pharmacologic
Brief summary
This study tests whether a virtually delivered integrated tai chi, qigong, and meditation program, added to usual care, improves chronic low back pain, disability, quality of life, and healthcare costs compared with usual care alone. Adults with chronic low back pain are randomized to begin the program immediately (Tai Chi Now) or after a six-month period (Tai Chi Later). Outcomes are collected by online survey over twelve months.
Detailed description
Pragmatic randomized crossover design with delayed start. Participants are randomized 1:1 to Tai Chi Now (immediate program plus usual care) or Tai Chi Later (usual care for six months, then delayed access to the same twelve-month program). Delivery is entirely virtual by Zoom. The program is a three-month foundation phase (two 60-minute live classes per week) followed by nine months of monthly booster sessions and guided home practice. Co-primary clinical endpoints are change in pain (BPI-4) and disability (ODI) from baseline to three months, both required to reach significance. Secondary endpoints include EQ-5D-5L quality of life, healthcare costs, work productivity (WPAI), and cost-effectiveness. Participants and program staff are not blinded; the study statistician analyzes data blinded to group identity.
Interventions
BEHAVIORALVirtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM)
Virtually Delivered Integrated Tai Chi, Qigong, and Meditation (VDTQM). Mapped to Arm 1 (immediate) and Arm 2 (delayed start).
Sponsors
New York Medical College
Center for Taiji and Qigong Studies (CTQS).
Weill Medical College of Cornell University
Columbia University
Yale University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Participants and program staff not masked; statistician analyzes blinded to group identity.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Age 18 years or older * Current non-specific low back pain lasting 12 weeks or more, with average pain over the past 7 days rated 4 or higher on a 0 to 10 scale * Understands written and spoken English * Has consistent internet access and is able to participate in virtual sessions * Agrees to appear on video during tai chi sessions, visible to the instructor and other participants * Willing to participate in a 12-month study including a 3-month foundation training phase with two 60-minute virtual live tai chi classes per week, 10 minutes of daily home practice, monthly 60-minute booster sessions during months 4 through 12, and five online surveys over 12 months at months 0, 2, 3, 6, and 12 * Willing and able to provide informed consent
Exclusion criteria
* Currently pregnant * Regular tai chi or qigong practice or research study participation in the past 5 years * History of spine surgery within the past 6 months * Severe psychiatric or medical comorbidities that, in the principal investigator's judgment, would make participation unsafe or not feasible Note on the second exclusion bullet: the protocol wording leaves open whether "research study participation" means participation in any research study or only in tai chi or qigong research. That wording has been carried over exactly as approved rather than clarified here, because the registry record should match the protocol. If the ambiguity is worth resolving, it belongs in a future amendment and then in a record update, not in this response.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Disability (ODI v2.1a) ODI: Oswestry Disability Index | 3 months | 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 | 3 months | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of life (EQ-5D-5L: EuroQol 5-Dimension 5-Level questionnaire) | 6 months | 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) | 6 months | 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) | 6 months | 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) | 6 months | Incremental cost per QALY gained. Time Frame: T0 to T6. |
Countries
United States
Contacts
CONTACTKenneth Knapp, PhD
CONTACTAllison Asher, DrPH
Outcome results
None listed