NCT06153199 · University of Florida
Self-management of Low Back Pain in Horticulture Workers
What this study is about
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.
View original scientific description
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.
Interventions
BEHAVIORAL
Self-management videos
Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work
BEHAVIORAL
Check lists for ergonomic options
Guidance on ergonomic choices appropriate for work tasks not currently being used that are the most difficult due to back pain, using a checklist
BEHAVIORAL
Text reminders
Reminders to implement choices using graphics and gifs as well as motivational messages
BEHAVIORAL
Video review
Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments
Primary outcome measures
Roland Morris Disability Index
Time frame: 1 year
Disability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability
Numeric Pain Rating Severity
Time frame: 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
Pain Interference
Time frame: 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 persistence
Time frame: 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.
Pain impact
Time frame: 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
Time frame: 1 year
Number of days in the past week pain is experienced ranging from 0-7
Adoption
Time frame: 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
Difficulty with work tasks
Time frame: 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
Time frame: 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
Time frame: 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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.
Exclusion criteria
- history of major trauma, surgery, or spinal nerve blocks in the past year
- seeking disability or workman's compensation
- self-disclosed pregnancy
Where
- Gainesville, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 31, 2025 · Source of record for eligibility and locations