NCT06153199 Self-management of Low Back Pain in Horticulture Workers
| NCT ID | NCT06153199 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of Florida |
| Condition | Back Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 164 participants |
| Start Date | 2024-06-06 |
| Primary Completion | 2026-06-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 164 participants in total. It began in 2024-06-06 with a primary completion date of 2026-06-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: Workers 1. working full time (30 hours or more per week) in physically demanding nursery or landscape work 2. currently employed or self-employed in nursery or landscape businesses 3. 18 years of age or older 4. English or Spanish speaking 5. experiencing continuous or intermittent LBP over the past 3 months Owners, managers, supervisors 1. 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. 2. All owners, managers, and supervisors who are willing to participate will be enrolled. Exclusion Criteria: Workers 1. history of major trauma, surgery, or spinal nerve blocks in the past year 2. seeking disability or workman's compensation 3. self-disclosed pregnancy
Contact & Investigator
Kim Dunleavy, PT, PhD
PRINCIPAL INVESTIGATOR
University of Florida
Frequently Asked Questions
Who can join the NCT06153199 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Back Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06153199 currently recruiting?
Yes, NCT06153199 is actively recruiting participants. Contact the research team at kdunleavy@phhp.ufl.edu for enrollment information.
Where is the NCT06153199 trial being conducted?
This trial is being conducted at Gainesville, United States.
Who is sponsoring the NCT06153199 clinical trial?
NCT06153199 is sponsored by University of Florida. The principal investigator is Kim Dunleavy, PT, PhD at University of Florida. The trial plans to enroll 164 participants.