Self-management of Low Back Pain in Horticulture Workers

NCT ID: NCT06153199

Last Updated: 2025-07-31

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

164 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-06-06

Study Completion Date

2026-06-30

Brief Summary

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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

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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

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Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Self-management videos

Intervention Type BEHAVIORAL

Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work

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

Group Type EXPERIMENTAL

Self-management videos

Intervention Type BEHAVIORAL

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 options

Intervention Type BEHAVIORAL

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 reminders

Intervention Type BEHAVIORAL

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

Video review

Intervention Type BEHAVIORAL

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

Interventions

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Self-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

Intervention Type BEHAVIORAL

Check 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

Intervention Type BEHAVIORAL

Text reminders

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

Intervention Type BEHAVIORAL

Video review

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

Intervention Type BEHAVIORAL

Other Intervention Names

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Self-management training Text and Graphic reminders Video feedback

Eligibility Criteria

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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

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Florida

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Kim Dunleavy, PT, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Florida

Locations

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University of Florida

Gainesville, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Kim Dunleavy, PT, PhD

Role: CONTACT

13522736114

Janeen Blythe, PT, DPT, ATC

Role: CONTACT

15613191035

Facility Contacts

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Kim Dunleavy

Role: primary

734-717-1848

References

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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.

Reference Type BACKGROUND
PMID: 39874582 (View on PubMed)

Other Identifiers

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IRB202300756

Identifier Type: -

Identifier Source: org_study_id

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