Back PainNCT06153199
Self-management of Low Back Pain in Horticulture Workers
A study testing Self-management videos, Check lists for ergonomic options and Text reminders in people with Back Pain, run by University of Florida at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Back Pain
- What is being tested?
- Self-management videos, Check lists for ergonomic options and Text reminders
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Jun 2024to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Show all 9Show fewer
- 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.
Who cannot join
- Workers
- history of major trauma, surgery, or spinal nerve blocks in the past year
- seeking disability or workman's compensation
- self-disclosed pregnancy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Florida
Gainesville, Florida, 32608
Kim Dunleavy, 734-717-1848, kdunleavy@phhp.ufl.edu
Heidi Radunovich, PhD
About this study
Official title: 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.
Read the 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.
- Conditions
- Back Pain
- Being tested
- Self-management videos, Check lists for ergonomic options, Text reminders, Video review
- Keywords
- Self-management, Ergonomics, Horticulture workers, Video training, Guided participatory choices, Text message reminders
- Medical subject headings
- Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Self-management videosBehavioural
Also called Self-management training
Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work
Check lists for ergonomic optionsBehavioural
Guidance on ergonomic choices appropriate for work tasks not currently being used that are the most difficult due to back pain, using a checklist
Text remindersBehavioural
Also called Text and Graphic reminders
Reminders to implement choices using graphics and gifs as well as motivational messages
Video reviewBehavioural
Also called Video feedback
Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments
| Study group | Role | What they receive |
|---|---|---|
| Self-management videos | Active comparator | 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 Receives: Behavioral: Self-management videos |
| Self-management videos + Multimodal personalized support | Experimental | 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 Receives: Behavioral: Self-management videos; Behavioral: Check lists for ergonomic options; Behavioral: Text reminders; Behavioral: Video review |
What is being measured
The primary outcome is the main question the study is designed to answer.
Roland Morris Disability Index
Disability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability
Measured: 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
Measured: 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
Measured: 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.
Measured: 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
Measured: 1 year
Pain frequency
Number of days in the past week pain is experienced ranging from 0-7
Measured: 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
Measured: 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.
Measured: 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
Measured: 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.
Measured: 1 yeat
Secondary outcomes (5)
Depression scale
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
Measured: 1 year
Pain anxiety Symptom Scale
20 item instrument with the total of items reported from never to always reported out of 50. Lower values are optimal.
Measured: 1 year
Self-efficacy for Chronic Disease Management
PROMIS short form 8a Self-efficacy chronic disease management
Measured: 1 year
Coping Skills Questionaire
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
Measured: 1 year
Ergonomic risk
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2023
- Study start6 Jun 2024
- Primary completion30 Jun 2026 (estimated)
- Study completion30 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Back PainStudies of the same condition, open and under way.
- More trials run by University of FloridaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Kim Dunleavy, PT, PhD, Principal investigator, University of Florida
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06153199
- Sponsor's protocol ID
- IRB202300756
- Status last verified
- Jul 2025
- First submitted
- 15 Nov 2023
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 39874582
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers
- ClinicalTrials.gov ID
- NCT06153199
- Acronym / sponsor ID
- IRB202300756
- Conditions
- Back Pain
- Keywords
- Self-management, Ergonomics, Horticulture workers, Video training, Guided participatory choices, Text message reminders
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- University of FloridaUniversity, hospital or other
- Study start
- 6 Jun 2024 (actual)
- Primary completion
- 30 Jun 2026 (estimated)
- Study completion
- 30 Jun 2026 (estimated)
- First posted
- 1 Dec 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Self-management videos | Active comparator | Behavioral: Self-management videosParticipants 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 | Experimental | Behavioral: Self-management videos, Behavioral: Check lists for ergonomic options, Behavioral: Text reminders, Behavioral: Video reviewParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (4 listed)
- Workers
- history of major trauma, surgery, or spinal nerve blocks in the past year
- seeking disability or workman's compensation
- self-disclosed pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Self-management videosAlso: Self-management trainingShort video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work | Behavioural | Self-management videos, Self-management videos + Multimodal personalized support |
| Check lists for ergonomic optionsGuidance on ergonomic choices appropriate for work tasks not currently being used that are the most difficult due to back pain, using a checklist | Behavioural | Self-management videos + Multimodal personalized support |
| Text remindersAlso: Text and Graphic remindersReminders to implement choices using graphics and gifs as well as motivational messages | Behavioural | Self-management videos + Multimodal personalized support |
| Video reviewAlso: Video feedbackParticipants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments | Behavioural | Self-management videos + Multimodal personalized support |
Primary outcome
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.
5 secondary outcomes
Depression scale
Time frame: 1 year
Pain anxiety Symptom Scale
Time frame: 1 year
Self-efficacy for Chronic Disease Management
Time frame: 1 year
Coping Skills Questionaire
Time frame: 1 year
Ergonomic risk
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
- Background: PubMed 39874582Dunleavy 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Kim Dunleavy, PT, PhD principal investigator
University of Florida
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Self-management videos, Check lists for ergonomic options and Text reminders in people with Back Pain, run by University of Florida at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kim Dunleavy, PT, PhD (13522736114, kdunleavy@phhp.ufl.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Roland Morris Disability Index (time frame: 1 year). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06153199, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2025.