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Self-management of Low Back Pain in Horticulture Workers

Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers

Status
Recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06153199
Enrollment
164
Registered
2023-12-01
Start date
2024-06-06
Completion date
2026-06-30
Last updated
2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain

Keywords

Self-management, Ergonomics, Horticulture workers, Video training, Guided participatory choices, Text message reminders

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.

Detailed 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.

Interventions

BEHAVIORALVideo review

Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments

BEHAVIORALSelf-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

BEHAVIORALCheck 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

BEHAVIORALText reminders

Reminders to implement choices using graphics and gifs as well as motivational messages

Sponsors

University of Florida
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

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

Design outcomes

Primary

MeasureTime frameDescription
Use of medication and substances1 yeatFrequency 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.
Pain impact1 year2 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 frequency1 yearNumber of days in the past week pain is experienced ranging from 0-7
Adoption1 yearUse 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 tasks1 yearPatient 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 ability1 yearWork Ability short form is reported on numeric rating scale from 0 (completely unable to work) to 10 able to work at your best
Roland Morris Disability Index1 yearDisability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability
Numeric Pain Rating Severity1 yearSeverity 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 Interference1 yearExtent 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 persistence1 yearPain in the past 3 months reported on a 5 item scale ranging from not at all to pain every day without a break.

Secondary

MeasureTime frameDescription
Ergonomic risk6 monthsRapid Ergonomic Behavioral Assessment rubric for video analysis for adjusted tasks rated out of a total of 15 indicating risk levels ranging from 1 negligible to very high
Depression scale1 yearCenter for Epidemiology Depression Scale -Revised consists of 20 items reflecting frequency of depressive symptoms from rarely to most of the time with the total reported out of 60 with lower values as optimal
Pain anxiety Symptom Scale1 year20 item instrument with the total of items reported from never to always reported out of 50. Lower values are optimal.
Self-efficacy for Chronic Disease Management1 yearPROMIS short form 8a Self-efficacy chronic disease management
Coping Skills Questionaire1 yearCoping Skills Questionnaire reporting confidence to be able to work and live a normal lifestyle rated on a 6 point scale from 0=not at all confident to 5=completely confident (total reported out of 10, and 7 point scale for control over pain 0=no control, 6=completely in control. The total is reported out of 12 with higher values as optimal

Countries

United States

Contacts

Primary ContactKim Dunleavy, PT, PhD
kdunleavy@phhp.ufl.edu13522736114
Backup ContactJaneen Blythe, PT, DPT, ATC
janeenmccormick@ufl.edu15613191035

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 5, 2026