Pilot Study of Personalized Patient Education for Chronic Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 2
- 主要终点
- Change from Baseline Personal Pain Beliefs on Pain Self-Efficacy Questionnaire (PSEQ) at Day 21
研究概览
简要总结
The goal of this pilot single-arm study is to examine the potential of personalized patient education materials to improve self-efficacy and perceived functional disability in patients with chronic low back pain. The main questions it aims to answer are:
- What is the feasibility of delivering a personalized patient education program for individuals with chronic low back pain?
- What is the impact of personalized patient education materials on disease-specific self-efficacy and patient-reported function in a small sample of individuals with chronic low back pain?
Participants will be asked to:
- access and complete online baseline questionnaires
- access and follow online patient materials on chronic low back pain on days 5, 8, 11, 14, and 17
- access and complete online follow-up responses to baseline questionnaires and a post-study survey
详细描述
This is a pilot single-arm study to examine the potential of personalized patient education materials to improve self-efficacy and perceived functional disability for patients with chronic low back pain (cLBP).
The investigators aim to recruit 30 individuals with cLBP. The investigators will aim to recruit 15 individuals from areas with an Area Deprivation Index (ADI) of at least 6 and 15 from areas with an ADI of 5 or lower.
Participants will complete a 3-week educational intervention aimed at improving self-efficacy in managing chronic LBP. Educational materials will be personalized for each participant depending upon things like baseline knowledge of cLBP, smoking status, exercise status, beliefs about safe movement with cLBP, preference for various health care interventions, and nature of work (sedentary vs. labor-oriented job).
Educational materials will be provided electronically using Qualtrics.
Participants will complete outcome measures at baseline and follow-up as described elsewhere in this study record.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 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
- •At least 18 years old
- •Existence of chronic low back pain, defined as back pain that has lasted longer than 12 weeks
- •Has sought care for LBP within the past 12 months, confirmable through medical records
- •Classified as having at least "moderate" LBP-related disability, defined as a raw score of 15 or higher (out of 50) on the Oswestry Disability Index (additional detail below in Outcomes) upon telephone screening
- •Patients who receive care through UPMC: The study team will confirm in Epic that the participant has indeed had a health care encounter that included a diagnosis of low back pain in the previous 12 months
- •Patients who receive care outside of UPMC: The potential participant can provide a physician letter, after visit summary, or other reasonable documentation to confirm that they have indeed sought health care for LBP within the previous 12 months
- •(for 50% of participants) Area Deprivation Index (ADI) of 6 or higher, using the Pennsylvania-specific deciles. The investigators will use ADI as a marker of socioeconomic status. Although the sample size in this study will not be large enough to detect the ability of the intervention to reduce socioeconomic disparities in chronic LBP outcomes, the investigators do need to show that the investigators are able to recruit a sufficient population of individuals of lower socioeconomic status and individuals of higher socioeconomic status to demonstrate feasibility for a future larger study. State-level ADI is measured from 1 to 10, with lower scores indicating greater advantage, and higher scores indicating greater deprivation. It is measured at the level of a census block group. The investigators will identify a potential participant's ADI by inputting their address of residence into the Neighborhood Atlas mapping tool, which is freely available online at https://www.neighborhoodatlas.medicine.wisc.edu/mapping
排除标准
- •any prior spine surgery
- •any orthopaedic surgery in the past 6 months
- •does not have own smartphone, tablet, laptop, or desktop to access study questionnaires and education materials
结局指标
主要结局
Change from Baseline Personal Pain Beliefs on Pain Self-Efficacy Questionnaire (PSEQ) at Day 21
时间窗: Baseline Day 0 & Day 21
The PSEQ is a 10-item questionnaire that assesses an individual's confidence in performing specific functional activities despite ongoing pain. Reliability, validity, and internal consistency of the PSEQ have been established when used with patients with spine conditions. Possible scores range from 0-60 with higher scores indicating greater self-efficacy for managing pain. Change= (Day 21 score - Baseline score)
Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Recruitment
时间窗: Through overall study completion, about 7 months
\- recruitment of at least 30 participants in 3 months
Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Retention
时间窗: Through overall study completion, about 7 months
\- retention of at least 80% of those participants through follow-up data collection
Feasibility of delivering a personalized patient education program for individuals with chronic low back pain - Missing Data
时间窗: Through overall study completion, about 7 months
\- missing data of no greater than 20% for any given data element
次要结局
- Change from Baseline Subjective Level of Disability on Oswestry Disability Index (ODI) at Day 21(Baseline Day 0 & Day 21)
- Change from Baseline Pain on Numeric Pain Rating Scale (NPRS) at Day 21(Baseline Day 0 & Day 21)
研究者
Allyn Bove
Assistant Professor of Physical Therapy
University of Pittsburgh