Mind Body Intervention for Chronic Lower Back Pain: A Pilot Study
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 2
- 主要终点
- Visual Analogue Scale
研究概览
简要总结
This pilot study will evaluate the feasibility of having a non-behavioral health provider deliver a combination of manual therapy (MT) and cognitive behavioral therapy for pain (CBT-p). In addition, we will evaluate differences in outcomes in patients undergoing the combined intervention of CBT-p and MT and those undergoing MT alone.
详细描述
Given that this is a pilot study we will use simple descriptive statistics for patient characteristics, including age, sex, BMI and baseline scores on outcome measures. In addition we will assess the inter-rater reliability of the scoring of the delivery of the CBT-p by the two trained practitioners utilizing kappa statistics. We will perform data analyses using SPSS.
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)
入排标准
- 年龄范围
- 18 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 69 years of age with CLBP who are
- •"high risk" for poor prognosis based on SBST
- •currently undergoing chiropractic care.
排除标准
- •Contraindications to either MT or CBT-p.
- •Patients who are currently undergoing CBT-p
- •who have been treated for substance abuse in the past year.
结局指标
主要结局
Visual Analogue Scale
时间窗: Baseline and 6 weeks post baseline (immediately post intervention)
The VAS is a patient completed analogue measure that evaluates pain intensity on a 100 mm long horizontal line, which is anchored at each end with a statement representing the extremes of the dimension being measured. In this case the left hand side reads, "no pain" and the right hand side reads "worst pain possible". The VAS scale utilized will assess pain at the current time. The VAS has been established as a reliable, valid and generalizable measure that can be administered in a wide range of clinical and experimental settings.
次要结局
- PROMIS Global Health Scale (GHS)(Baseline and 6 weeks post baseline (immediately post intervention))
研究者
Paul Dougherty, DC
Chiropractor
Canandaigua VA Medical Center