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Recruiting NCT06153199

Self-management of Low Back Pain in Horticulture Workers

No phase Interventional Back Pain

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Self-management videos, Check lists for ergonomic options, Text reminders, Video review.
Who it may be relevant to
Registry conditions: Back Pain. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Interventions

  • Behavioral 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
  • 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
  • Behavioral Text reminders
    Reminders to implement choices using graphics and gifs as well as motivational messages
  • Behavioral Video review
    Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments

Primary outcome measures

  • Roland Morris Disability Index [Time frame: 1 year]
  • Numeric Pain Rating Severity [Time frame: 1 year]
  • Pain Interference [Time frame: 1 year]
  • Pain persistence [Time frame: 1 year]
  • Pain impact [Time frame: 1 year]
  • Pain frequency [Time frame: 1 year]
  • Adoption [Time frame: 1 year]
  • Difficulty with work tasks [Time frame: 1 year]
  • Work ability [Time frame: 1 year]
  • Use of medication and substances [Time frame: 1 yeat]
Secondary outcome measures (5)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • University of Florida — Gainesville

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. PMID 39874582

Identifiers

NCT: NCT06153199 · IRB202300756

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗