Effectiveness of an Electronic Decision Support System (DeSSBack) in Improving the Management of Low Back Pain: A Cluster Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 210
- 试验地点
- 1
- 主要终点
- Changes in health status measure for low back pain between baseline and 6-month
研究概览
简要总结
Low back pain is a common health problem where over than half a billion people worldwide suffers from it. In Malaysia, back pain is among the top ten reasons why people see a doctor. Although there are many guidelines available, healthcare professionals still find managing low back pain as challenging.
The Decision Support System for Low Back Pain (DeSSBack) has been developed by adopting and re-packaging STaRT system, incorporate with the local clinical practice guidelines and feedback from local experts. It aims to aid healthcare professionals in managing low back pain through a stratified approach.
The objective of the study is to evaluate the effectiveness of DeSSBack in improving the management of patients with low back pain in a primary care clinic. We hypothesise that the implementation of DeSSBack will improve the outcomes of low back pain patients including quality of life, emotional state and level of pain.
This study protocol presents the rationale and design of a cluster randomized controlled trial.
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 (Participant)
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
- •Patient seeking care for low back pain at the primary care clinic in UMMC
- •Male and female
- •Age 18 years and above
- •Can understand Malay and English
排除标准
- •Potentially serious pathology (eg: cauda equina compression, inflammatory arthritis, malignancy and etc)
- •Serious co morbidity
- •Psychiatric illness or personality disorder
- •Spinal surgery in the last 6 months
- •Already receiving treatment other than primary care for this episode of back pain
- •Inability to attend regular physiotherapy appointments.
研究组 & 干预措施
Control group
Usual care
Intervention group
DeSSBack (Decision Support System for Low Back Pain)
干预措施: DeSSBack (Other)
结局指标
主要结局
Changes in health status measure for low back pain between baseline and 6-month
时间窗: Baseline, 6-months
We are measuring the changes in health status with Rolland Morris Disability Questionnaire (RMDQ). The score ranges from a minimum of 0 to a maximum of 24. Greater levels of disability are reflected by higher scores.
Changes in health status measure for low back pain between baseline and 2-month
时间窗: Baseline, 2-months
We are measuring the changes in health status with Rolland Morris Disability Questionnaire (RMDQ). The score ranges from a minimum of 0 to a maximum of 24. Greater levels of disability are reflected by higher scores.
次要结局
- Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 6-month(Baseline, 6-months)
- Changes in the back pain severity score between baseline and 2-month(Baseline, 2-months)
- Changes in the back pain severity score between baseline and 6-month(Baseline, 6-months)
- Changes in the Hospital Anxiety and Depression Scale (HADS) between baseline and 2-month(Baseline, 2-months)
研究者
Dr. Teo Chin Hai
Senior Lecturer
University of Malaya