Recruiting

Observational Study

Sponsor:

University of Florida

Code:

NCT06153199

Conditions

Back Pain

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

Self-management videos

Check lists for ergonomic options

Text reminders

Video review

Study Details

Brief 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 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.

Conditions

Back Pain

Study ID

NCT06153199

Start date

Jun 6, 2024

Status verified date

Jul, 2025

Completion date

Jun 30, 2026

Anticipated

Primary completion date

Jun 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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 Design

Enrollment

164 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

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

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

Interventions

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

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

Text reminders

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

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 measure

  • 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 ]

Central Contacts and Locations

Central contacts

Janeen Blythe, PT, DPT, ATC

15613191035janeenmccormick@ufl.edu

Locations

University of Florida

Recruiting

Gainesville, Florida, United States, 32608

Contacts

More Information

Sponsor

University of Florida

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • Self-management
  • Ergonomics
  • Horticulture workers
  • Video training
  • Guided participatory choices
  • Text message reminders

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of Florida on 2025-07-31.