A Pragmatic Randomized Controlled Trial of Virtual Tai Chi for Chronic Low Back Pain: Effects on Disability, Pain, Quality of Life, and Healthcare Costs
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Disability (ODI v2.1a) ODI: Oswestry Disability Index
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Participants and program staff not masked; statistician analyzes blinded to group identity.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
Disability (ODI v2.1a) ODI: Oswestry Disability Index
时间窗: 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
时间窗: 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.
次要结局
- Quality of life (EQ-5D-5L: EuroQol 5-Dimension 5-Level questionnaire)(6 months)
- Healthcare costs (RUQ: Resource Use Questionnaire)(6 months)
- Work productivity (WPAI-SHP: Work Productivity and Activity Impairment Questionnaire, Specific Health Problem version)(6 months)
- Cost-effectiveness (ICER: incremental cost-effectiveness ratio)(6 months)
研究者
Allison Asher
Principal Investigator
New York Medical College