Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT03524378 |
| Other study ID # |
IRB201702245 - N |
| Secondary ID |
3U54OH011230-02S |
| Status |
Completed |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
June 1, 2018 |
| Est. completion date |
October 29, 2022 |
Study information
| Verified date |
November 2022 |
| Source |
University of Florida |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Chronic low back pain has been identified as a major problem for seafood and agricultural
workers, and is known to affect worker health and productivity. The aims of this study are
to: 1) identify modifiable, sector-specific, work and movement solutions with the potential
to reduce the burden or severity of chronic lower back pain in clam workers and 2) determine
the extent that participants adopt identified solution(s), and the impact on functional
difficulty and low back pain.
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 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
1. 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.
2. 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.
1. 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.
2. 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.
3. 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.
