Self-management of Low Back Pain in Horticulture Workers

July 28, 2025 updated by: University of Florida

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

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.

Study Overview

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.

Study Type

Interventional

Enrollment (Estimated)

164

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Contact:
        • Sub-Investigator:
          • Heidi Radunovich, PhD
        • Sub-Investigator:
          • Kelly Gurka, PhD
        • Sub-Investigator:
          • Jason Beneciuk, PT, PhD
        • Sub-Investigator:
          • Boyi Hu, PhD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Self-management videos
Participants 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
Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work
Other Names:
  • Self-management training
Experimental: Self-management videos + Multimodal personalized support

Participants 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

Reminders to implement choices using graphics and gifs as well as motivational messages
Other Names:
  • Text and Graphic reminders
Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work
Other Names:
  • Self-management training
Guidance on ergonomic choices appropriate for work tasks not currently being used that are the most difficult due to back pain, using a checklist
Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments
Other Names:
  • Video feedback

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 year
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
1 year
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
1 year
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.
1 year
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
1 year
Pain frequency
Time Frame: 1 year
Number of days in the past week pain is experienced ranging from 0-7
1 year
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
1 year
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.
1 year
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
1 year
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.
1 yeat

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Depression scale
Time Frame: 1 year
Center 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
1 year
Pain anxiety Symptom Scale
Time Frame: 1 year
20 item instrument with the total of items reported from never to always reported out of 50. Lower values are optimal.
1 year
Self-efficacy for Chronic Disease Management
Time Frame: 1 year
PROMIS short form 8a Self-efficacy chronic disease management
1 year
Coping Skills Questionaire
Time Frame: 1 year
Coping 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
1 year
Ergonomic risk
Time Frame: 6 months
Rapid 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
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Kim Dunleavy, PT, PhD, University of Florida

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 6, 2024

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

June 30, 2026

Study Registration Dates

First Submitted

November 15, 2023

First Submitted That Met QC Criteria

November 29, 2023

First Posted (Actual)

December 1, 2023

Study Record Updates

Last Update Posted (Actual)

July 31, 2025

Last Update Submitted That Met QC Criteria

July 28, 2025

Last Verified

July 1, 2025

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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