Recruitment

Recruitment Status
Recruiting
Estimated Enrollment
34

Summary

Conditions
Chronic Low Back Pain
Type
Interventional
Phase
Not Applicable
Design
Allocation: N/AIntervention Model: Single Group AssignmentMasking: None (Open Label)Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 60 years
Gender
Both males and females

Description

This pilot/feasibility pre-post intervention study will use a participatory ergonomic approach without a control group or randomization. The participatory approach will foster capacity building by creating support within the workplace communities and by involving seafood workers in developing contex...

This pilot/feasibility pre-post intervention study will use a participatory ergonomic approach without a control group or randomization. The participatory approach will foster capacity building by creating support within the workplace communities and by involving seafood workers in developing context specific solutions for their own work practice, increasing the potential for adoption and success. Phase 1: Specific Aim 1: Identify modifiable, sector-specific work and movement solutions with that can reduce the burden or severity of chronic lower back pain Development of rapid prototype video clips: clam workers will be videotaped performing typical work tasks during daily operations on the boat, as well as transporting, sorting and packing clams will be analyzed. Key movements and positions such as lifting, prolonged static flexed positions that may be contributing to repetitive stress in the low back region will be categorized. Short clips will be edited to create examples of movements and positions for each category potentially contributing to low back pain. Prioritization of specific tasks and relevant solutions by key leaders: Up to 10 participants with a history of chronic low back pain for more than 3 months will be recruited by the Cedar Key Aquaculture Association for the initial pilot testing of research methods. Once participants have provided informed consent, they will complete a general demographic survey, functional disability and pain questionnaire and surveys to measure co-variates that include pain fear and anxiety, self-efficacy and coping questions. Focus groups will be held in the participant's work settings with consented individuals from the same work teams to ensure application within a specific context and promote discussion directed towards the best outcomes. Participants will discuss major tasks and factors contributing to their low back pain using the video clips to target discussions and their opinions of options that would help alleviate or prevent pain. Only clips from the relevant teams will be used for each focus group. The focus groups will be recorded and transcribed for analysis and as a record of discussion. Basic principles of ergonomic adaptation and movement modification for repetitive work activities on and off the boat and lifting will be introduced using demonstrations and discussion in a small group format. Participants will discuss other possible solutions. Self-management including movement strategies and pain relief techniques will be introduced and demonstrated by the principal investigator. The educational session will be videotaped to ensure all relevant discussions are considered during the development of interventions and to assist with reliability of intervention delivery. At the end of the focus group and educational session, participants will prioritize their most problematic work tasks and most relevant and feasible solutions. In a follow up visit, participants will be videotaped demonstrating the tasks and selected methods to reduce or prevent repetitive stress determined from the focus group. With permission from the participants, selected videos will be edited to provide clips to be used in subsequent workshops. Only participants who agree to be videotaped for educational purposes will be included in this session. Phase II: Specific Aim 2: Determine the extent that participants adopt identified solution(s), and the impact of their self-selected work and movement modifications on their functional difficulty in the workplace related to low back pain. In addition to the workers recruited for specific aim 1, up to 24 additional clam workers for a total of up to 34 participants will be recruited with the same criteria; chronic low back pain for more than 3 months, over the age of 18 and employed full time in clam gathering/preparation. Baseline: Once participants have provided informed consent, they will complete a general demographic survey, functional disability and pain questionnaire and surveys to measure co-variates that include pain fear and anxiety, self-efficacy and coping questions. Functional disability, pain reports and work related functional ability will be recorded once a week for 4 weeks. Implementation of interventions, focus group discussion and identification of individual solutions: After the baseline period, workers will contribute to small focus groups of 4-6 individuals in their work team. After introduction of basic ergonomic and self-management principles, participants will review video clips of the prioritized and revised solutions identified in Specific Aim 1. After indicating their preferences, the feasibility of solutions will be discussed. Following this discussion, participants will indicate if they believe that the adjustments in work tasks, movement strategies or self-management apply to their work, are easy to implement and are likely to decrease their back pain. Workers will suggest any additional options to implement the ergonomic principles. At the end of the focus group, participants will select 3 options to use in their work activities for 8 weeks. Follow up: The research team will contact participants by text or phone once a week to provide reminders. At 4 weeks the initial survey data will be repeated. The frequency and consistency of use of the solutions during work activities will be reported to reflect adoption, along with any pre-post changes in measures. After completion of the 8 weeks, individuals will also comment on the effectiveness, feasibility and impact of solutions on their low back pain and job performance. Participants will also be asked to suggest options for implementation and provide feedback on how to optimize the intervention for wider dissemination, and if they would recommend the solutions to co-workers.

Tracking Information

NCT #
NCT03524378
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
Investigators
Principal Investigator: Kim Dunleavy, PhD University of Florida