Self-management of Low Back Pain in Horticulture Workers
Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers
1 other identifier
interventional
164
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2024
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 15, 2023
CompletedFirst Posted
Study publicly available on registry
December 1, 2023
CompletedStudy Start
First participant enrolled
June 6, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 30, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 30, 2026
July 31, 2025
July 1, 2025
2.1 years
November 15, 2023
July 28, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (10)
Roland Morris Disability Index
Disability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability
1 year
Numeric Pain Rating Severity
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
1 year
Pain Interference
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
1 year
Pain persistence
Pain in the past 3 months reported on a 5 item scale ranging from not at all to pain every day without a break.
1 year
Pain impact
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
1 year
Pain frequency
Number of days in the past week pain is experienced ranging from 0-7
1 year
Adoption
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
1 year
Difficulty with work tasks
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.
1 year
Work ability
Work Ability short form is reported on numeric rating scale from 0 (completely unable to work) to 10 able to work at your best
1 year
Use of medication and substances
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.
1 yeat
Secondary Outcomes (5)
Depression scale
1 year
Pain anxiety Symptom Scale
1 year
Self-efficacy for Chronic Disease Management
1 year
Coping Skills Questionaire
1 year
Ergonomic risk
6 months
Study Arms (2)
Self-management videos
ACTIVE COMPARATORParticipants will review short video modules on pain self-management without medication and ergonomic work adjustment and select 1 self-management option and 1 ergonomic option to use for 10 weeks
Self-management videos + Multimodal personalized support
EXPERIMENTALParticipants will review short video modules on pain self-management without medication and ergonomic work adjustment and select 1 self-management option and 1 ergonomic option to use for 10 weeks. Participants will use 1) checklists to guided choices for strategies based on their self-identified most difficult work activities due to pain and options that they are not using regularly, 2) review video recordings of their own work movements to assist with ergonomic problem-solving and 3) receive text message reminders
Interventions
Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work
Guidance on ergonomic choices appropriate for work tasks not currently being used that are the most difficult due to back pain, using a checklist
Reminders to implement choices using graphics and gifs as well as motivational messages
Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments
Eligibility Criteria
You may qualify if:
- Workers
- 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
- years of age or older
- English or Spanish speaking
- experiencing continuous or intermittent LBP over the past 3 months
- Owners, managers, supervisors
- All owners, managers, and supervisors who are willing to participate will be enrolled.
You may not qualify if:
- Workers
- history of major trauma, surgery, or spinal nerve blocks in the past year
- seeking disability or workman's compensation
- self-disclosed pregnancy
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Florida
Gainesville, Florida, 32608, United States
Related Publications (1)
Dunleavy K, Radunovich HL, Beneciuk JM, Hu B, Yang Y, Blythe JM, Gurka KK. Self-Management Strategies for Low Back Pain Among Horticulture Workers: Protocol for a Type II Hybrid Effectiveness-Implementation Study. JMIR Res Protoc. 2025 Jan 28;14:e64817. doi: 10.2196/64817.
PMID: 39874582BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Kim Dunleavy, PT, PhD
University of Florida
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 15, 2023
First Posted
December 1, 2023
Study Start
June 6, 2024
Primary Completion (Estimated)
June 30, 2026
Study Completion (Estimated)
June 30, 2026
Last Updated
July 31, 2025
Record last verified: 2025-07
Data Sharing
- IPD Sharing
- Will not share