NCT Number: NCT06153199
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
Gainesville, Florida, 32608, United States
Location status: Recruiting
Boyi Hu, PhD
SUB_INVESTIGATOR
Heidi Radunovich, PhD
SUB_INVESTIGATOR
Jason Beneciuk, PT, PhD
SUB_INVESTIGATOR
Kelly Gurka, PhD
SUB_INVESTIGATOR
Kim Dunleavy
CONTACT
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Workers
Owners, managers, supervisors
Exclusion criteria
Workers
Short video modules on self-management of back pain without medication and ergonomic adjustments for limiting back pain in nursery and landscape work
Other names: Self-management training
Guidance on ergonomic choices appropriate for work tasks not currently being used that are the most difficult due to back pain, using a checklist
Reminders to implement choices using graphics and gifs as well as motivational messages
Other names: Text and Graphic reminders
Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments
Other names: Video feedback
Time frame: 1 year
Disability Index for functional difficulties related to low back pain scored from 0-24 with low scores indicating lower disability
Time frame: 1 year
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
Time frame: 1 year
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
Time frame: 1 year
Pain in the past 3 months reported on a 5 item scale ranging from not at all to pain every day without a break.
Time frame: 1 year
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
Time frame: 1 year
Number of days in the past week pain is experienced ranging from 0-7
Time frame: 1 year
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
Time frame: 1 year
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.
Time frame: 1 year
Work Ability short form is reported on numeric rating scale from 0 (completely unable to work) to 10 able to work at your best
Time frame: 1 yeat
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.
Time frame: 1 year
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
Time frame: 1 year
20 item instrument with the total of items reported from never to always reported out of 50. Lower values are optimal.
Time frame: 1 year
PROMIS short form 8a Self-efficacy chronic disease management
Time frame: 1 year
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
Time frame: 6 months
Rapid Ergonomic Behavioral Assessment rubric for video analysis for adjusted tasks rated out of a total of 15 indicating risk levels ranging from 1 negligible to very high
Contact information is provided by the study sponsor or research team.
Janeen Blythe, PT, DPT, ATC
CONTACT
Kim Dunleavy, PT, PhD
CONTACT
University of Florida
Other
Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07632820
Back Pain, Neurologic Manifestations
Jacksonville, Florida, United States
View Trial DetailsNCT07633730
Ankylosing Spondylitis (AS), Ankylosis
Istanbul, Pendik, Turkey (Türkiye)
View Trial DetailsNCT04982965
Back Pain, Bone Diseases
La Jolla, California, United States
View Trial DetailsNCT07579182
Activity, Motor, Back Pain
Houston, Texas, United States
View Trial Details