Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 164
- 试验地点
- 2
- 主要终点
- Pain Interference
研究概览
简要总结
The primary purpose of this hybrid Type II comparative effectiveness and implementation study is to compare two self-management strategies in nursery and landscape workers. This randomized pragmatic study will compare interventions with different degrees of support to determine if self-management videos plus multimodal personalized support is more effective than self-management videos alone for improving LBP among horticulture workers. Both groups will review short self-management video modules to introduce general pain concepts and the importance of managing pain without medication, risks of opioid use, self-management of pain, and simple ergonomic strategies for both groups. Both groups will choose 1 self-management strategy to manage pain at home and 1 ergonomic workplace strategy to limit pain. The video+support group will receive 1) check-list guidance, 2) review videos of their work tasks, and 3) receive text reminders to support implementation. Surveys will include instruments reflecting low back pain disability, pain, work ability, and affective or cognitive characteristics (self-efficacy, pain anxiety, depression, coping), collected at baseline, pre- and post-intervention, with follow-ups at 3- and 6-months. Workers will be videoed pre- and post-intervention for calculation of work risk and to compare any changes after the intervention. Specific aim 2 will identify contextual factors impacting engagement, adoption, effectiveness, and implementation. Interviews, focus groups, and field notes will be used to explain results and establish patterns to inform future translation.
详细描述
Primary dependent variables will be collected at all measurement points: pain severity, interference, and persistence, pain with specific work tasks, disability, work ability, and pain medication use. Affective or cognitive characteristics potentially impacting adoption and effectiveness (secondary dependent variables or confounders) such as coping, fear, anxiety, depression, will also be collected.The post- and follow-up survey questions will also reflect adoption, opinions of interventions, effectiveness, facilitators, and barriers.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 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
- 是
入选标准
- •working full time (30 hours or more per week) in physically demanding nursery or landscape work
- •currently employed or self-employed in nursery or landscape businesses
- •18 years of age or older
- •English or Spanish speaking
- •experiencing continuous or intermittent LBP over the past 3 months
- •Owners, managers, supervisors
- •Owners, managers, or supervisors who meet the same inclusion criteria as workers will be eligible to participate in the training interventions as well as the supervisory roles.
- •All owners, managers, and supervisors who are willing to participate will be enrolled.
排除标准
- •history of major trauma, surgery, or spinal nerve blocks in the past year
- •seeking disability or workman's compensation
- •self-disclosed pregnancy
结局指标
主要结局
Pain Interference
时间窗: 1 year
Extent of pain interference with work activities in the past week, 0=not at all, 100=prevented working at normal level, lower scores reflect less interference
Pain impact
时间窗: 1 year
2 items with 5 point scale recording impact on work activities and social activities ranging from never to always, with lower scores reflecting less impact
Pain frequency
时间窗: 1 year
Number of days in the past week pain is experienced ranging from 0-7
Pain persistence
时间窗: 1 year
Pain in the past 3 months reported on a 5 item scale ranging from not at all to pain every day without a break.
Adoption
时间窗: 1 year
Use of the interventions reported for each work or self-management strategy selected (number of days used in the past week, how often used (never, occassionally, consistently) Higher scores and consistently are optimal
Numeric Pain Rating Severity
时间窗: 1 year
Severity of pain reported for the past week and for the 3 most difficult work activities 0=no pain, 100=worst imaginable pain, lower scores reflect lower pain
Roland Morris Disability Index
时间窗: 1 year
Disability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability
Difficulty with work tasks
时间窗: 1 year
Patient Specific Functional Scale reported for 3 most difficult work activities with subscales reported on a scale of 0= no difficulty, 100=unable to perform with the average of the 3 items used for analysis.
Work ability
时间窗: 1 year
Work Ability short form is reported on numeric rating scale from 0 (completely unable to work) to 10 able to work at your best
Use of medication and substances
时间窗: 1 yeat
Frequency of pain medication and substances for pain in past 3 months reported on a 4 item scale (never, 1-2 days, 3-4 days, 5-7 days) never is optimal. Items for alcohol, cannabis, tobacco, herbal products, acetaminophen, anti-inflammatories, muscle relaxants, opioids). Frequency of use per day on average also reported for a total estimate.
次要结局
- Ergonomic risk(6 months)
- Pain anxiety Symptom Scale(1 year)
- Self-efficacy for Chronic Disease Management(1 year)
- Depression scale(1 year)
- Coping Skills Questionaire(1 year)