Self-management of Low Back Pain in Horticulture Workers

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

The primary purpose of this hybrid comparative effectiveness and implementation study is to compare two self-management strategies to manage pain, and adjust work-related ergonomic risk in nursery and landscape workers. This cluster randomized pragmatic study will compare interventions with different degrees of support and Specific aim 1 is to determine if self-management plus individualized guided participatory ergonomic choices (SM+PE) is more effective than self-management (SM) 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 SM+PE participant's choices will be guided using branching logic questions matched to their self-identified most difficult work activities due to pain. guide choices matched to participant's most difficult work activities. This group will also: 1) review videos of their work tasks, 2) receive text reminders to support implementation, and 3) supervisors will participate in additional discussions of processes and support of workers. 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 to inform simulated work analysis for calculation of work risk and to compare any changes for the most difficult tasks. 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.

Study Overview

• Status: Not yet recruiting
• Conditions: Back Pain
• Intervention / Treatment: Behavioral: Video training - Self-management; Behavioral: Video training - Ergonomics; Behavioral: Supervisor training; Behavioral: Guided choice of ergonomic options matched to most difficult tasks; Behavioral: Prioritized lists of self management options; Behavioral: Text reminders

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.71-74 Affective or cognitive characteristics potentially impacting adoption and effectiveness (secondary dependent variables or confounders) such as coping, fear, anxiety, depression, will also be collected.75-78 The post- and follow-up survey questions will also reflect adoption, opinions of interventions, effectiveness, facilitators, and barriers.

• Study Type: Interventional
• Enrollment (Estimated): 170
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kim Dunleavy, PT, PhD; Phone Number: 13522736114; Email: kdunleavy@phhp.ufl.edu
• Study Contact Backup: Name: Janeen Blythe, PT, DPT, ATC; Phone Number: 15613191035; Email: janeenmccormick@ufl.edu

Study Locations

• United States
  • Florida
    • Gainesville, Florida, United States, 32608
      • University of Florida
      • Contact: Kim Dunleavy; Phone Number: 734-717-1848; Email: kdunleavy@phhp.ufl.edu
      • Sub-Investigator: Heidi Radunovich, PhD
      • Sub-Investigator: Kelly Gurka, PhD
      • Sub-Investigator: Jason Beneciuk, PT, PhD
      • Sub-Investigator: Boyi Hu, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: Yes

Description

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 (<20) or medium (21-40) 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
6. willing to be videotaped during work activities for movement analysis

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Self-management; Participants will review short video modules on pain self-management without medication and ergonomic work adjustment Participants will be asked to select 1 self-management option and 1 ergonomic option to use for 10 weeks	Behavioral: Video training - Self-management; Short video modules on self-management of back pain without medication; Other Names: Self-management training; Behavioral: Video training - Ergonomics; Short video module on ergonomic adjustment for limiting back pain in nursery and landscape work
Experimental: Self-management and Guided Participatory Ergonomics; Participants will review short video modules on pain self-management without medication and ergonomic work adjustment Supervisors in these work settings will also discuss options to adjust work processes and ways to support workers implement ergonomic strategies Participants will be asked to select 1 self-management option and 1 ergonomic option to use for 10 weeks. This group will receive options guided by their self-identified most difficult work activities due to pain and options that they are not using regularly.	Behavioral: Video training - Self-management; Short video modules on self-management of back pain without medication; Other Names: Self-management training; Behavioral: Video training - Ergonomics; Short video module on ergonomic adjustment for limiting back pain in nursery and landscape work; Behavioral: Supervisor training; In person discussion of work processes and support for workers to implement self-management and ergonomic modifications; Behavioral: Guided choice of ergonomic options matched to most difficult tasks; Survey based guidance on ergonomic choices appropriate for work tasks that are the most difficult due to back pain; Behavioral: Prioritized lists of self management options; Survey based guidance for prioritized choices of self-management; Behavioral: Text reminders; Reminders to implement choices

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Roland Morris Disability Index	Disability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability	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	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	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.	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	1 year
Pain frequency	Number of days in the past week pain is experienced ranging from 0-7	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	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.	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year
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	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.	1 year
Self-efficacy	PROMIS short form 8a Self-efficacy chronic disease management	1 year
Self-efficacy and coping - confidence and control over pain	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	1 year
Ergonomic risk	Rapid Ergonomic Behavioral Assessment rubric for video analysis with specific criteria rated out of a total of 15 indicating risk levels ranging from 1 negligible to very high	6 months

Collaborators and Investigators

• Sponsor: University of Florida
• Investigators: Principal Investigator: Kim Dunleavy, PT, PhD, University of Florida

Study record dates

Study Major Dates

• Study Start (Estimated): March 15, 2024
• Primary Completion (Estimated): December 15, 2028
• Study Completion (Estimated): March 15, 2029

Study Registration Dates

• First Submitted: November 15, 2023
• First Submitted That Met QC Criteria: November 29, 2023
• First Posted (Actual): December 1, 2023

Study Record Updates

• Last Update Posted (Actual): February 22, 2024
• Last Update Submitted That Met QC Criteria: February 21, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: IRB202300756

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No