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Clinical Trial Summary

The primary purpose of this hybrid comparative effectiveness and implementation study is to compare two self-management strategies to manage pain, and adjust work-related ergonomic risk in nursery and landscape workers. This cluster randomized pragmatic study will compare interventions with different degrees of support and Specific aim 1 is to determine if self-management plus individualized guided participatory ergonomic choices (SM+PE) is more effective than self-management (SM) 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 SM+PE participant's choices will be guided by researchers to match to their self-identified most difficult work activities due to pain and to those strategies that could be used more often rather than just their preferences. This group will also: 1) review videos of their work tasks, and 2) 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 to inform simulated work analysis for calculation of work risk and to compare any changes for the most difficult tasks. 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.


Clinical Trial Description

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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06153199
Study type Interventional
Source University of Florida
Contact Kim Dunleavy, PT, PhD
Phone 13522736114
Email kdunleavy@phhp.ufl.edu
Status Recruiting
Phase N/A
Start date June 6, 2024
Completion date June 30, 2028

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