Targeted Interventions to Prevent Chronic Low Back Pain in High Risk Patients: A Multi-Site Pragmatic Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,300
- 试验地点
- 5
- 主要终点
- Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
研究概览
简要总结
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a pragmatic, cluster randomized trial. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines. The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP. The 1,860 patients expected to be enrolled at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period.
详细描述
Low back pain (LBP) is a common problem among US adults. Initial episodes tend to be self-limited ("acute"), but some people can progress to a state of persistent pain. Often termed "chronic" LBP (cLBP), this condition can cause prolonged difficulty with most daily activities, including job performance. Most patients see chiropractors or primary care physicians (PCPs) for initial episodes of LBP. This study will compare two approaches for preventing patients with acute LBP (aLBP) from developing cLBP using a cluster randomized trial. Both treatments can be delivered in an outpatient PCP setting. The first approach is to provide PCPs with information regarding a patient's risk of transitioning from aLBP to cLBP and to encourage PCPs to treat patients according to accepted clinical guidelines (Guideline Based Care, GBC). The second approach is to provide the same risk information and have PCPs team up with physical therapists to deliver psychologically-informed physical therapy (PIPT) for those patients determined to be at high risk for transitioning to cLBP (GBC+PIPT). PIPT is designed to help patients identify and overcome physical and psychological barriers to recovery. The 1,860 patients expected to be enrolled as part of quality improvement at five regional sites (Pittsburgh, Pennsylvania; Boston, Massachusetts; Baltimore, Maryland; Charleston, South Carolina; and Salt Lake City, Utah) will start the study when their LBP is in an acute phase. The study's primary aims are to compare the proportions of cLBP and measures of functional ability between the two groups at 6 months. Secondary aims are to measure the referrals to physical therapists and specialists, opioid prescriptions, LBP-related x-rays or MRIs, surgeries, and other medical procedures during a 12-month follow-up period. This study was designed with input from a variety of national and local stakeholders, including patients with LBP, providers, payers, professional organizations, purchasers, and policy representatives.
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
- None
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
- •18 years of age or older
- •Receiving care for acute low back pain during a primary care clinic visit
- •Able to provide informed consent
排除标准
- •Medical contraindications to physical therapy based on the judgment of the primary care provider as documented in the medical record (i.e., "red flag" signs and symptoms of a potentially serious condition such as cauda equina syndrome, major or rapidly progressing neurological deficit, cancer, spinal infection or fracture)
研究组 & 干预措施
GBC+PIPT
Guideline Based Care plus Psychologically Informed Physical Therapy (GBC+PIPT)
干预措施: Guideline Based Care plus Psychologically Informed Physical Therapy (Behavioral)
GBC
Guideline Based Care (GBC)
干预措施: Guideline Based Care (GBC) (Behavioral)
结局指标
主要结局
Number of Patients Who Reported Transition From Acute to Chronic Low Back Pain (cLBP)
时间窗: 6 months from baseline
Measured using a 2-item Chronic Low Back Pain (LBP) questionnaire. Patient endorses low back pain that interferes with regular daily activities more than 3 months and more then 1/2 the days in the past 6 months.
Functional Disability
时间窗: 6 months
Measured using the 10-item Oswestry Disability Index (version 2.1a). Also known as the Oswestry Low Back Pain Disability Questionnaire. A measure of a patient's functional disability. The scale ranges from 0% to 100% with higher scores indicating more disability.
次要结局
- Number of Patients Referred to Surgery Specialist(12 months)
- Number of Patients Referred to Other Rehabilitation or Pain Management Specialist(12 months)
- Number of Patients Prescribed Opioids(12 months)
- Number of Patients With Orders for Diagnostic Imaging Tests(12 months)
- Number of Patients Who Had Back Surgery(12 months)
- Number of Patients Referred to Physical Therapy(12 months)
- Number of Patients Undergoing Interventional Pain Procedures(12 months)
研究者
Anthony Delitto
Professor and Dean, SHRS
University of Pittsburgh