Supporting Patient Activation for Self-Management of Chronic Low Back Pain With a Targeted Intervention Based on Key Influencing Characteristics
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 2
- 主要终点
- Acceptability of research
研究概览
简要总结
Patients with chronic low back (cLBP) pain report reduced physical function and ability to participate in social roles and are more likely to use opioid pain medications. While self-management interventions have been shown to support these patients, effectiveness has been limited due to poor patient engagement. "Patient activation" encompasses the skills, knowledge, and motivation that a person has to manage the person's health. Supporting patient activation may improve the effectiveness of self-management for cLBP.
In this single-masked pilot study of adults with cLBP, patients were randomized to receive either no intervention (control) or 6 weekly sessions of an evidence-based web-based self-management program (SMP) with or without health behavior change counseling (HBCC) using motivational interviewing. Participants were assessed at baseline and at 12 and 26 weeks using the Patient Activation Measure, Oswestry Disability Index and Patient-Reported Outcomes Measurement Information System (PROMIS) physical function, social role participation, and pain interference. The investigators assessed acceptability and feasibility based on recruitment, session attendance, and follow-up.
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
The outcomes assessors were masked to treatment assignment
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
- •Adults (18+ years of age)
- •Seen in primary or specialty care practice for non-specific low back pain
- •Chronic low back pain per the NIH Task Force on Research Standards for cLBP
- •Worst back pain of at least 4/10 points
- •Oswestry disability index of at least 24%
- •English speaking
排除标准
- •History of lumbar spine decompression/laminectomy or fusion surgery in the past 6 months
- •Possible non-musculoskeletal cause for LBP symptoms diagnosis at baseline
- •"Red flag" LBP diagnosis in the previous 6 months (e.g., cauda equina syndrome, osteomyelitis, or spinal neoplasm)
- •Neurological disorder resulting in moderate to severe movement dysfunction
- •Presence of any psychotic disorder
结局指标
主要结局
Acceptability of research
时间窗: Baseline
Acceptability - at least 50% of individuals approached agree to eligibility screening for the study, having at least 30% of those who were deemed eligible for the study agree to participate
Feasibility of study
时间窗: Baseline
Feasibility - (1) having at least 80% of enrolled participants attend at least 3 of the 6 scheduled self-management program sessions; and (2) having a loss to follow-up rate of \< 20% of enrolled participants over the 26-week study
次要结局
- Oswestry Disability Index (ODI) score(12 weeks)
- Patient Activation Measure (PAM) score(12 weeks)