Clinical trial NCT06153199: Self-management of Low Back Pain in Horticulture Workers
Official title: Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Back Pain
Keywords: Self-management
Ergonomics
Horticulture workers
Video training
Guided participatory choices
Text message reminders
Lead sponsor: University of Florida
Sponsor class: OTHER
First posted: 2023-12-01
Enrollment: 164
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: 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 small or medium size 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

Primary outcomes:
measure: Roland Morris Disability Index
timeFrame: 1 year
measure: Numeric Pain Rating Severity
timeFrame: 1 year
measure: Pain Interference
timeFrame: 1 year
measure: Pain persistence
timeFrame: 1 year
measure: Pain impact
timeFrame: 1 year
measure: Pain frequency
timeFrame: 1 year
measure: Adoption
timeFrame: 1 year
measure: Difficulty with work tasks
timeFrame: 1 year
measure: Work ability
timeFrame: 1 year
measure: Use of medication and substances
timeFrame: 1 yeat
Secondary outcomes:
measure: Depression scale
timeFrame: 1 year
measure: Pain anxiety Symptom Scale
timeFrame: 1 year
measure: Self-efficacy for Chronic Disease Management
timeFrame: 1 year
measure: Coping Skills Questionaire
timeFrame: 1 year
measure: Ergonomic risk
timeFrame: 6 months
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Kim Dunleavy, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: