Pragmatic Trial of Acupuncture for Chronic Low Back Pain in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 807
- 试验地点
- 4
- 主要终点
- Change in Back-related Disability at 6-month Post Randomization (Continuous)
研究概览
简要总结
The main goal of the BackInAction research study is to determine the effectiveness of a standard course of acupuncture (15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults (65+ years) with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
详细描述
Background: A critical gap exists in evidence regarding the safety and effectiveness of treatments for older adults (65+ years) with chronic low back pain. Acupuncture has been found to be effective in treating chronic low back pain in younger adults. Yet trials have rarely included older adults, who have more comorbidities and may respond differently than typical trial participants. BackInAction has been designed to address this gap.
Purpose: The main goal of BackInAction is to evaluate the effectiveness of a standard course of acupuncture (up to 15 sessions of acupuncture over 3 months) and an enhanced course of acupuncture (up to an additional 6 sessions of acupuncture over months 4-6) in improving back-related disability in older adults with chronic low back pain compared to usual care alone. Key secondary aims are to determine the effectiveness of acupuncture in improving a composite score of pain intensity and pain interference.
Design and Outcomes: In this pragmatic, three-arm parallel groups multi-site randomized controlled trial, the investigators will recruit and randomize at least 789 adults ≥ 65 years of age with chronic low back to standard acupuncture, enhanced acupuncture, or usual medical care alone in four health-care systems. These include two integrated health care systems, a fee-for-service system and a network of federally qualified health centers. Primary outcome data will be collected by questionnaire at 3-, 6-, and 12-months post-randomization. In addition, short monthly surveys will capture data on physical function and a composite score of pain intensity and pain interference.
Interventions and Duration: Standard acupuncture will consist of 3 months (90 days) of acupuncture needling, with a proposed minimum of 8 treatments and a maximum of 15. Enhanced acupuncture will include the standard acupuncture plus an additional 3-month maintenance period, with a maximum of six additional treatments. Usual medical care will consist of the care that individuals receive according to their insurance benefits plus anything else they pay for out of pocket. The investigators will ask those assigned to usual medical care to avoid acupuncture for the year they are enrolled in the study. Both active treatment arms will also have access to usual medical care. Participants will be enrolled in the study for 12 months.
Sample Size and Population: BackInAction will include patients at least 65 years of age with uncomplicated chronic low back pain with or without radiculopathy. The investigators plan to enroll at least 789 participants (263 per study arm). Participants will be recruited from four health plans, with varying numbers of participants from each site. Randomization will be stratified by health care system, age category and gender. The investigators expect the racial and ethnic mix will roughly parallel that of the older Medicare population.
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
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is at least 65 years of age
- •Is a current member or patient of the healthcare system
- •Visited a health care provider for low back pain within the past 12 months
- •Received primary care at one of the participating health care systems
- •Has back pain that is uncomplicated with or without radicular pain
- •Back pain at least 3 months
- •General activity question from PEG (Pain, Pain Interference with Enjoyment, General Activity scale) at least 3
- •Primary care provider provides permission to contact patient
- •Willing and able to provide consent (Callahan cognitive impairment screener at least 3)
排除标准
- •Specific types of back pain (metastatic cancer or bone cancer or secondary cancers, vertebral fractures, spinal infection, active inflammatory disease)
- •Low back surgery within past 3 months
- •Receiving workers compensation or involved in litigation related to chronic low back pain
- •Acupuncture within the last 6 months
- •Does not speak or write English or Spanish
- •Major psychosis, dementia
- •Current cancer treatment
- •Red flags of serious underlying illness (a fever most days in the last month; recent unexplained weight loss of 10 lbs or more)
- •Living in a nursing home, on Hospice, or palliative care
- •Non-speaking deafness
- •Non-reliable transportation
结局指标
主要结局
Change in Back-related Disability at 6-month Post Randomization (Continuous)
时间窗: Baseline to 6-month
Change in back-related disability is defined as score change in Roland Morris Disability Questionnaire (RMDQ), a 24-item questionnaire which asked whether 24 specific activities were limited due to back pain during the past week. The RMDQ is scored from 0 to 24, with higher scores indicating more disability. Greater change between baseline and 6-months would indicate greater improvement.
次要结局
- Change in Back-related Disability at 3-, and 12-month (Continuous)(Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months)
- Achieving Minimal Clinically Important Difference (MCID) in Back-related Disability at 3-, 6-, and 12-months (Binary)(Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months)
- Patient Global Impression of Change (PGIC) at 3-, 6-, and 12- Months(Study primary outcome timepoint: 6 months; Test of Standard Acupuncture: 3 months; Test of Maintenance effect: 12 months)
- Change in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6- and 12-month (Continuous)(Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months)
- Achieving MCID in Pain, Pain Interference With Enjoyment, General Activity (PEG) at 3-, 6-, and 12-months (Binary)(Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months)
- Change in Physical Functioning at 3-, 6- and 12-month (Continuous)(Study primary outcome timepoint: Baseline to 6 months; Test of Standard Acupuncture: Baseline to 3 months; Test of Maintenance effect: Baseline to 12 months)
- Serious Adverse Effects (SAE)/Non-Serious Adverse Effects (AE)(SAE: 12 months from electronic health record data; AE: 12 months from acupuncture treatment records and follow-up interviews.)