- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06153199
Self-management of Low Back Pain in Horticulture Workers
Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers
Study Overview
Status
Conditions
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Kim Dunleavy, PT, PhD
- Phone Number: 13522736114
- Email: kdunleavy@phhp.ufl.edu
Study Contact Backup
- Name: Janeen Blythe, PT, DPT, ATC
- Phone Number: 15613191035
- Email: janeenmccormick@ufl.edu
Study Locations
-
-
Florida
-
Gainesville, Florida, United States, 32608
- Recruiting
- University of Florida
-
Contact:
- Kim Dunleavy
- Phone Number: 734-717-1848
- Email: kdunleavy@phhp.ufl.edu
-
Sub-Investigator:
- Heidi Radunovich, PhD
-
Sub-Investigator:
- Kelly Gurka, PhD
-
Sub-Investigator:
- Jason Beneciuk, PT, PhD
-
Sub-Investigator:
- Boyi Hu, PhD
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
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
- 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:
Workers
- history of major trauma, surgery, or spinal nerve blocks in the past year
- seeking disability or workman's compensation
- self-disclosed pregnancy
Study Plan
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:
|
|
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:
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:
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:
|
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
Sponsor
Investigators
- Principal Investigator: Kim Dunleavy, PT, PhD, University of Florida
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRB202300756
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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