Self-management of Low Back Pain in Horticulture Workers

Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06153199
• Other study ID #: IRB202300756
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2024
• Est. completion date: June 30, 2028

Study information

• Verified date: June 2024
• Source: University of Florida
• Contact: Kim Dunleavy, PT, PhD
• Phone: 13522736114
• Email: kdunleavy[@]phhp.ufl.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 by researchers to match to their self-identified most difficult work activities due to pain and to those strategies that could be used more often rather than just their preferences. This group will also: 1) review videos of their work tasks, and 2) 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 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 164
• Est. completion date: June 30, 2028
• Est. primary completion date: June 30, 2028
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Behavioral:
• Video training - Self-management
Short video modules on self-management of back pain without medication
• Video training - Ergonomics
Short video module on ergonomic adjustment for limiting back pain in nursery and landscape work
• Guided choice of ergonomic options matched to most difficult tasks
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 adjust ergonomic adjustments

Locations

Country	Name	City	State
United States	University of Florida	Gainesville	Florida

Sponsors (1)

Lead Sponsor	Collaborator
University of Florida

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Pain frequency	Number of days in the past week pain is experienced ranging from 0-7	1 year
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	Self-efficacy	PROMIS short form 8a Self-efficacy chronic disease management	1 year
Secondary	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
Secondary	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