Optimized Multidisciplinary Treatment Programs for Nonspecific Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 749
- 试验地点
- 3
- 主要终点
- Change in Oswestry Disability Index From Baseline to 10 Weeks
研究概览
简要总结
The objective of this study is to improve health care for patients with chronic LBP and increase the likelihood that patients obtain outcomes that matter most to them. The investigators will accomplish our goal using a sequential multiple randomization (SMART) design comparing the effectiveness of Phase 1 (PT v. CBT) treatments for patients with chronic LBP; and among patient non-responsive to Phase I treatment, compare the effectiveness of Phase II treatments (switching to PT or CBT v. mindfulness). Effectiveness will be based on patient-centered outcomes. Sub-aims will compare main effects of Phase 1 and 2 treatment options and the sequencing effects of different treatment combinations.
详细描述
The study uses a sequential multiple randomization (SMART) design. The study will compare the effectiveness of common first-line treatments for chronic LBP: PT or CBT. Initial treatment will be 8 weeks duration with re-evaluation at 10-weeks after enrollment to allow time to complete treatment. At the 10-week assessment researchers will examine if the patient has responded to initial treatment using a patient-centered, validated definition of successful response based on 50% improvement in the Oswestry Disability Index (ODI). Patients who are responders to initial treatment will receive up to 2 additional sessions of the same treatment to assist transition to self-management. Non-responders will be re-randomized to a second treatment strategy of either switching to the other initial treatment (i.e., patients receiving PT switch to CBT or vice versa), or mindfulness. The second treatment phase is also 8 weeks in duration. Additional follow-ups occur 26- and 52 weeks after enrollment.
The study has two co-primary outcomes; function and pain. The investigators will use the ODI, a well-validated, reliable and responsive patient-reported measure of LBP-related function recommended by the NIH Back Pain Task Force. The investigators will assess pain intensity with 0-10 ratings ('0' indicating no pain and '10' worst imaginable pain). Separate ratings are made for current, worst and best pain over the past 24 hours with an average computed to represent pain intensity. Secondary outcomes will assess dimensions of quality of life, work and healthcare utilization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Participants and clinicians cannot be blind to treatment received. The investigators will remain blind to group assignment and follow-up assessments will be conducted by assessors who are blind to treatment group.
入排标准
- 年龄范围
- 18 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 - 64 years at the time of enrollment.
- •Meets NIH Task Force definition of chronic LBP based on two questions: 1) How long has LBP has been an ongoing problem for you? and 2) How often has LBP been an ongoing problem for you over the past 6 months? A response of greater than 3 months to question 1, and "at least half the days in the past 6 months" to question 2 is required to satisfy the NIH definition of chronic LBP.
- •Healthcare visit for LBP in the past 90 days.
- •At least moderate levels of pain and disability requiring ODI score >24 and pain intensity rating >
- •Has access to two-way video technology, such as smartphone, iPad/tablet, or laptop with webcam for telehealth visits.
排除标准
- •Evidence of serious pathology as a cause of LBP including neoplasm, inflammatory disease (e.g., ankylosing spondylitis), vertebral osteomyelitis, etc.
- •Evidence of a specific spinal pathology as the cause of LBP including spine fracture, spinal stenosis, radiculopathy, etc.
- •Knowingly pregnant
- •Has received physical therapy for LBP; or CBT or mindfulness for any reason with a provider in prior 90 days
- •Currently receiving substance use disorder treatment
- •Any lumbar spine surgery in the past year.
研究组 & 干预措施
PT followed by Switching to CBT in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
干预措施: Physical Therapy (Behavioral)
PT followed by Switching to CBT in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will switch to 8 weekly sessions of cognitive behavioral therapy (CBT) as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
干预措施: Cognitive Behavioral Therapy (Behavioral)
PT followed by Mindfulness in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
干预措施: Physical Therapy (Behavioral)
PT followed by Mindfulness in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of evidence-based physical therapy (PT). At the 10-week follow-up participants who are non-responders to Phase I PT will receive 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I PT, he or she will receive up to 2 more PT sessions in Phase II of treatment.
干预措施: Mindfulness (Behavioral)
CBT followed by Switching to PT in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
干预措施: Physical Therapy (Behavioral)
CBT followed by Switching to PT in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of evidence-based physical therapy (PT) as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
干预措施: Cognitive Behavioral Therapy (Behavioral)
CBT followed by Mindfulness in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
干预措施: Cognitive Behavioral Therapy (Behavioral)
CBT followed by Mindfulness in Phase II for nonresponders
Phase I treatment is 8 weekly sessions of cognitive behavioral therapy (CBT). At the 10-week follow-up participants who are non-responders to Phase I CBT will switch to 8 weekly sessions of mindfulness using a mindfulness-oriented recovery enhancement protocol as Phase II treatment. If participant is a responder to Phase I CBT, he or she will receive up to 2 more CBT sessions in Phase II of treatment.
干预措施: Mindfulness (Behavioral)
Phase I PT Treatment
This arm includes participants assigned to PT as their Phase I treatment
干预措施: Physical Therapy (Behavioral)
Phase I CBT Treatment
This arm includes participants assigned to CBT for their Phase I treatment
干预措施: Cognitive Behavioral Therapy (Behavioral)
Phase II Switching Treatment
Includes all Non-Responders in Phase I who were re-randomized to Switch in Phase II
干预措施: Phase I Treatment (Behavioral)
Phase II Switching Treatment
Includes all Non-Responders in Phase I who were re-randomized to Switch in Phase II
干预措施: Phase II Switching (Behavioral)
Phase II Mindfulness Treatment
Include all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II
干预措施: Mindfulness (Behavioral)
Phase II Mindfulness Treatment
Include all Non-Responders in Phase I who were re-randomized to Mindfulness in Phase II
干预措施: Phase I Treatment (Behavioral)
结局指标
主要结局
Change in Oswestry Disability Index From Baseline to 10 Weeks
时间窗: baseline, 10 weeks
Back pain specific measure of functional disability to address Aim 1, score range 0-100 with neagtive values representing improvement in disability
Change in Oswestry Disability Index From 10-weeks to 52 Weeks
时间窗: 10 weeks, 52 weeks
Back pain specific measure of functional disability to address Aim 2, score range 0-100 with negative values representing improvement in disability
Change in Numeric Pain Intensity Rating From Baseline to 10 Weeks
时间窗: baseline, 10 weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 1. Negative values represent a reduction in pain intensity.
Change in Numeric Pain Intensity Rating From 10-weeks to 52 Weeks
时间窗: 10 weeks, 52 weeks
0-10 numeric rating of pain intensity measured as average of current, best and worst pain ratings in past 24 hours to address Aim 2. Negative values represent an improvement in pain intensity.
次要结局
- Health Care Utilization of Advanced Imaging for Back Pain Over 10 Weeks(baseline, 10 weeks)
- Health-related Quality of Life(baseline, 10 weeks, 26 weeks, 52 weeks)
- Change in Pain Interference From Baseline to 10 Weeks(baseline, 10 weeks)
- Change in Fatigue From Baseline to !0 Weeks(baseline, 10 weeks)
- Change in Sleep Disturbance From Baseline to 10 Weeks(baseline, 10 weeks)
- Change in Anxiety From Baseline to 10 Weeks(baseline, 10 weeks)
- Change in Depression From Baseline to 10 Weeks(baseline, 10 weeks)
- Change in Social Role Participation From Baseline to 10 Weeks(baseline, 10 weeks)
- Opioid Utilization at 10-week Assessment(baseline, 10 weeks)
- Treatment Side Effects(10 weeks)
- Treatment Responder(baseline, 10 weeks)
- Health Care Utilization of Injections for Back Pain Over 10 Weeks(baseline, 10 weeks)
- Health Care Utilization of Radiographs for Back Pain Over 10 Weeks(baseline, 10 weeks)
研究者
Julie Fritz
Distinguished Professor
University of Utah