[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT06153199":3,"trial-entities:NCT06153199":161,"trial-summary:NCT06153199":165},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":20,"study_type":27,"primary_purpose":28,"phases":29,"enrollment_info":31,"interventions":34,"primary_outcomes":59,"secondary_outcomes":92,"sex":109,"minimum_age":110,"maximum_age":111,"healthy_volunteers":112,"eligibility_criteria":113,"std_ages":117,"locations":120,"central_contacts":144,"overall_officials":152,"references":155,"see_also_links":160},"NCT06153199","IRB202300756","Self-management of Low Back Pain in Horticulture Workers","Effectiveness and Implementation of Self-management Strategies for Low Back Pain Among Horticulture Workers","RECRUITING","2026-06-30","2025-07","2025-07-31","2024-06-06","University of Florida","OTHER",false,"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.","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.",[19],"Back Pain",[21,22,23,24,25,26],"Self-management","Ergonomics","Horticulture workers","Video training","Guided participatory choices","Text message reminders","INTERVENTIONAL","PREVENTION",[30],"NA",{"count":32,"type":33},164,"ESTIMATED",[35,43,47,53],{"type":36,"name":37,"description":38,"armGroupLabels":39,"otherNames":41},"BEHAVIORAL","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",[37,40],"Self-management videos + Multimodal personalized support",[42],"Self-management training",{"type":36,"name":44,"description":45,"armGroupLabels":46},"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",[40],{"type":36,"name":48,"description":49,"armGroupLabels":50,"otherNames":51},"Text reminders","Reminders to implement choices using graphics and gifs as well as motivational messages",[40],[52],"Text and Graphic reminders",{"type":36,"name":54,"description":55,"armGroupLabels":56,"otherNames":57},"Video review","Participants will review videos of their movement during their most difficult work tasks to help problem solving to adjust ergonomic adjustments",[40],[58],"Video feedback",[60,64,67,70,73,76,79,82,85,88],{"measure":61,"description":62,"timeFrame":63},"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",{"measure":65,"description":66,"timeFrame":63},"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",{"measure":68,"description":69,"timeFrame":63},"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",{"measure":71,"description":72,"timeFrame":63},"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.",{"measure":74,"description":75,"timeFrame":63},"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",{"measure":77,"description":78,"timeFrame":63},"Pain frequency","Number of days in the past week pain is experienced ranging from 0-7",{"measure":80,"description":81,"timeFrame":63},"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",{"measure":83,"description":84,"timeFrame":63},"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.",{"measure":86,"description":87,"timeFrame":63},"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",{"measure":89,"description":90,"timeFrame":91},"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 yeat",[93,96,99,102,105],{"measure":94,"description":95,"timeFrame":63},"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",{"measure":97,"description":98,"timeFrame":63},"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.",{"measure":100,"description":101,"timeFrame":63},"Self-efficacy for Chronic Disease Management","PROMIS short form 8a Self-efficacy chronic disease management",{"measure":103,"description":104,"timeFrame":63},"Coping Skills Questionaire","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",{"measure":106,"description":107,"timeFrame":108},"Ergonomic risk","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","6 months","ALL","18 Years",null,true,{"inclusion":114,"exclusion":115,"raw_text":116},[],[],"Inclusion Criteria:\n\nWorkers\n\n1. working full time (30 hours or more per week) in physically demanding nursery or landscape work\n2. currently employed or self-employed in nursery or landscape businesses\n3. 18 years of age or older\n4. English or Spanish speaking\n5. experiencing continuous or intermittent LBP over the past 3 months\n\nOwners, managers, supervisors\n\n1. 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.\n2. All owners, managers, and supervisors who are willing to participate will be enrolled.\n\nExclusion Criteria:\n\nWorkers\n\n1. history of major trauma, surgery, or spinal nerve blocks in the past year\n2. seeking disability or workman's compensation\n3. self-disclosed pregnancy",[118,119],"ADULT","OLDER_ADULT",[121],{"facility":13,"status":8,"city":122,"state":123,"zip":124,"country":125,"contacts":126,"geoPoint":141},"Gainesville","Florida","32608","United States",[127,132,135,137,139],{"name":128,"role":129,"phone":130,"email":131},"Kim Dunleavy","CONTACT","734-717-1848","kdunleavy@phhp.ufl.edu",{"name":133,"role":134},"Heidi Radunovich, PhD","SUB_INVESTIGATOR",{"name":136,"role":134},"Kelly Gurka, PhD",{"name":138,"role":134},"Jason Beneciuk, PT, PhD",{"name":140,"role":134},"Boyi Hu, PhD",{"lat":142,"lon":143},29.65163,-82.32483,[145,148],{"name":146,"role":129,"phone":147,"email":131},"Kim Dunleavy, PT, PhD","13522736114",{"name":149,"role":129,"phone":150,"email":151},"Janeen Blythe, PT, DPT, ATC","15613191035","janeenmccormick@ufl.edu",[153],{"name":146,"affiliation":13,"role":154},"PRINCIPAL_INVESTIGATOR",[156],{"pmid":157,"type":158,"citation":159},"39874582","BACKGROUND","Dunleavy K, Radunovich HL, Beneciuk JM, Hu B, Yang Y, Blythe JM, Gurka KK. Self-Management Strategies for Low Back Pain Among Horticulture Workers: Protocol for a Type II Hybrid Effectiveness-Implementation Study. JMIR Res Protoc. 2025 Jan 28;14:e64817. doi: 10.2196\u002F64817.",[],{"nct_id":4,"conditions":162,"biomarkers":164},[163],"Lower Back Pain",[],{"nct_id":4,"found":112,"summary":166,"prompt_version":175},{"design":167,"status":168,"heading":6,"summary":169,"follow_up":170,"word_count":171,"commitments":172,"compensation":173,"drugs_mentioned":174},"This is a randomized study comparing two self-management strategies for low back pain in horticulture workers.","completed","This study is testing two ways to help horticulture workers manage low back pain (LBP). It compares self-management videos alone to self-management videos combined with personalized support. The personalized support includes checklists for ergonomic options (ways to arrange your workspace to prevent injury), text reminders, and video reviews of your movements during difficult work tasks. You might be able to join if you are 18 or older, work full-time in physically demanding nursery or landscape jobs, speak English or Spanish, and have had continuous or intermittent LBP for the past 3 months. The study will measure how much your pain severity, pain interference (how much pain affects your daily life), and disability improve after one year. The study plans to enroll 164 participants, but its current status is unclear.","Participants will be followed for one year to assess pain and disability.",129,"Not specified in the trial record.","Not stated in the trial record.",[37,48,54],"v2"]