Patient and Physical Therapist Perspectives on Spinal Manipulative Therapy for Low Back Pain
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- PROMIS-29
研究概览
简要总结
The goal of this study is to better understand how the thoughts and beliefs of patients with low back pain and their physical therapist influence how much patients benefit from physical therapy. Participants will receive physical therapy as determined by their physical therapist including spinal manipulative therapy, exercise, and education. Participants with low back pain and their physical therapists will complete forms about their thoughts and beliefs about low back pain and treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pain between 12th rib and buttocks with or without symptoms into one or both legs, which, in the opinion of the examiner, originate from the lumbar region.
- •Meets NIH Task Force criteria for chronic low back pain
排除标准
- •Prior surgery to the lumbosacral spine
- •Currently pregnant
- •Not currently receiving spinal manipulative therapy or exercise interventions from another healthcare provider such as a chiropractor or massage therapist.
- •No neurogenic signs indicating radiculopathy
- •No "red flags" of a potentially serious condition (e.g., cauda equina syndrome, fracture, cancer, infection, etc.)
研究组 & 干预措施
Patients
Patients seeking physical therapy for low back pain
干预措施: Physical therapy (Other)
Physical therapists
Physical therapists treating enrolled patients
干预措施: Physical therapist provider (Other)
结局指标
主要结局
PROMIS-29
时间窗: Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks
Assesses pain intensity using a single item and seven health domains (physical function, fatigue, pain interference, depressive symptoms, anxiety, ability to participate in social roles and activities, and sleep disturbance) using four items per domain. This will only be completed by patient participants in the study.
NIH Chronic LBP Impact Score
时间窗: 12 weeks and 26 weeks
Combines results of the Pain Intensity, Physical Function, and Pain Interference PROMIS scores. Scores range from 8 (least impact) to 50 (greatest impact).
次要结局
- Patient Acceptable Symptom State(Baseline and 2 weeks and 6 weeks and 12 weeks and 18 weeks and 26 weeks)