Effects of a Lower Back Wrap Device on Lower Back Pain, Physical Function, and Quality of Life
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 153
- 试验地点
- 2
- 主要终点
- Pain
研究概览
简要总结
The goal of this counterbalanced cross-over study is to determine whether a recovery lumbar wrap effectively reduces lower back pain and improves outcomes related to physical function and quality of life in adults with LBP in adults 20-65 years old. This study will also explore whether improvements in other health metrics that are typically related to, or seen in, lower back pain research (i.e. stiffness, mobility, physical activity, validated clinical scoring methods, etc.) are improved with the use of the product.
The main question this study aims to answer is:
• Does the lumbar wrap effectively reduce low back pain symptoms and improve outcomes related to physical function and quality of life in adults with lower back pain.
Participants experiencing lower back pain will be asked to use the lower back wrap for at least 20-minutes per day for a 2-week period, counterbalanced with a 2-week period of no device use. Participants will fill out small daily surveys about their symptoms and complete a pre-, middle-, and post- survey and functional screening to determine efficacy of the device.
详细描述
Participants with both acute and chronic low back pain will be recruited from the emergency department, research registry, social media, and e-mails. Participants will be screened for inclusion and exclusion criteria and consented. This study utilizes a counterbalanced cross-over design. Each participant will complete both conditions: 1) Intervention (wrap), or 2) Control (Nothing). A counterbalanced assignment approach will be used to determine the starting condition for each participant (Phase 1). After completion of Phase 1, each participant will complete the remaining condition for Phase 2.
Each phase of the intervention will take 2 weeks, for a total of 4 weeks (2 weeks in Phase 1, 2 weeks in Phase 2). When participants are in the Intervention phase of the study, they will be asked to use the lower back wrap at least once per day for the standard treatment length (20 minutes). To support ecological validity, participants will be able to use the device ad libitum (several times throughout the day) as desired. The Researchers will administer simple daily surveys to log compliance to treatment.
A pre-, mid-, and post- survey and functional screening will be conducted to gather additional information about the participant and device efficacy and use.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults aged 20 - 65
- •Males and Females (50-50 split or close)
- •Range of ethnicities
- •Range of BMIs
排除标准
- •Those with diagnosed cancer, infection, trauma, or LBP requiring surgical intervention
- •Those currently undergoing rehabilitation treatment for LBP
- •Those with other diagnosed conditions that may preclude them from safely participating
- •Pregnant women
- •Waist less than 26" or greater than 66" due to device limitations
结局指标
主要结局
Pain
时间窗: From enrollment to the end of treatment at 4 weeks
Patients will report their level of pain daily and reflect on their pain over the past over the past 1-week at the start of the study and past 2-weeks during the follow-up surveys Pain Scale: 1-10, higher score = more pain.
Function survey
时间窗: From enrollment to the end of treatment at 4 weeks
Function will be assessed daily and every 2-weeks by survey.
Function test
时间窗: From enrollment to the end of treatment at 4 weeks
Function will be assessed every 2-weeks by a function screening via 5-repitition sit-to-stand. Function Scale: 5 point scale from "not at all" to "very much" indicating how much pain interfered with day-to-day activities.
次要结局
- Medication usage(From enrollment to the end of treatment at 4 weeks)
- Other pain and rehabilitation use(From enrollment to the end of treatment at 4 weeks)
- Device use- Frequency(For the 2-week device use period.)
- Device use- Duration(For the 2-week device use period.)
- Device use- Type(For the 2-week device use period.)
研究者
Kyle Kelleran
Assistant Professor of Emergency Medicine
State University of New York at Buffalo