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CompletedNCT03524378Updated Nov 17, 2022

Modifiable Work and Movement Solutions Low Back Pain in Seafood Workers

An interventional study of Ergonomic and movement modifications in Chronic Low Back Pain, sponsored by University of Florida. Completed at 2 sites in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2022-11-17.

Sponsored by University of Florida · Not applicable, Interventional, and Treatment

Phase
Not applicable
Study type
Interventional
Enrollment
37
Allocation
Not applicable
Ages
18 Years to 60 Years
Sex
All
01

Study 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.

Read the detailed 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.
02

Conditions studied

  • Chronic Low Back Pain

Keywords

  • repetitive strain
  • ergonomics
  • participatory ergonomics
  • chronic low back pain
  • seafood workers
03

In context

Back Pain

2,373 studies on the registry are indexed under Back Pain; 284 are open to participants now.

This study's enrollment of 37 is below the median of 60 across 1,941 interventional studies indexed under Back Pain.

Browse Back Pain studies →

Lead sponsor

University of Florida is the lead sponsor of 1,254 studies on the registry; 201 are open to participants now.

Of its 170 completed or terminated interventional studies of FDA-regulated products, 136 (80%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 60 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • History of chronic low back pain
  • Employed full time in clam harvesting/processing

Exclusion criteria

Exclusion Criteria:

  • History of spinal surgery in past 3 years
  • Recent hospitalization in the past year for any condition
  • Subjects currently seeking disability
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
37 participants (actual)

Study arms

  • Other
    Ergonomic and movement modifications

    No group assignment - all participants will self select suitable ergonomic or movement modifications

    Behavioral: Ergonomic and movement modifications

Interventions

  • BehavioralErgonomic and movement modifications

    Introduction of basic ergonomic and self-management principles, participants will review video clips of the prioritized and revised solutions. Adjustments in work tasks, movement strategies or self-management techniques will be self selected by workers after an educational session using videotapes of work processes.

06

What researchers measure

Primary outcomes

  1. Patient Specific Functional Scale

    3 work items regarded as the most painful or difficult activities will selected by each participant and rated on a 0-100 scale with inability to complete a task rated as 0/100 and ability to perform the activity without any difficulty due to low back pain as a 100/100. Participants will also report the amount of time that they are able to complete the task without stopping or changing tasks due to low back pain for each activity.

    Time frame: Change from baseline average measured over 4 weeks, after 4 and 8 weeks

  2. Pain rating scales

    Pain ratings for each of the items identified in the patient specific functional scale (best, worst and average ratings) over the past day with 0/100 reflecting no pain, 100/100 most excruciating pain possible

    Time frame: Change from baseline average measured over 4 weeks, after 4 and 8 weeks

Secondary outcomes

  1. Short form pain anxiety symptom scale

    Self reported survey to reflect anxiety (Ranges from 0-5 with 5 being always in pain)

    Time frame: Baseline, Day 1, 4 weeks, 8 weeks

  2. Fear avoidance single item question

    Single item question to reflect fear avoidance measured as both a co-variate or possible outcome

    Time frame: Baseline, Day 1, 4 weeks, 8 weeks

  3. Pain self-efficacy questions

    Two questions to reflect fear avoidance measured as both a co-variate or outcome

    Time frame: Baseline, Day 1, 4 weeks, 8 weeks

  4. Pain coping questions

    Two questions to reflect fear avoidance measured as both a co-variate or outcome

    Time frame: Baseline, Day 1, 4 weeks, 8 weeks

  5. Oswestry Disability Index for low back pain

    Modified Oswestry Disability Index is a valid and reliable self reported instrument reflecting disability related to low back pain. Ten items related to difficulty with activities of daily living are scored on a 0-5 scale, 0 representing no difficulty, 5 representing the greatest disability. An index is calculated by dividing the summed score by the total possible score, which is then multiplied by 100 and expressed as a percentage. 0-20% is considered minimal disability; 21%-40%: moderate disability:41%-60%: severe disability: 61%-80%: extremely severe disability; 81%-100%:complete disability

    Time frame: Baseline, at 4 weeks and after intervention at 8 weeks

Other outcomes

  1. Adoption of strategies

    Number of individuals adopting work-related methods for more than 50% of the time

    Time frame: 8 weeks

07

Study locations

2 sites
  • Cedar Key Aquaculture Association
    Cedar Key, Florida 32625, United States
  • UF Health
    Gainesville, Florida 32611, United States
08

References and documents

Publications

  • Dunleavy K, Kane A, Coffman A, Reidy J, Bishop MD. Outcomes of Participatory Ergonomics and Self-management in Commercial Clam Farmers with Chronic Low Back Pain: A Feasibility Study. J Agromedicine. 2022 Apr;27(2):217-231. doi: 10.1080/1059924X.2021.2004961. Epub 2021 Nov 23. PubMed 34772318 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03524378
Lead sponsor
University of Florida
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
Responsible party
Sponsor
First posted
May 14, 2018
Start date
Jun 1, 2018
Primary completion
Oct 29, 2022
Completion
Oct 29, 2022
Last update
Nov 17, 2022

Study contacts

Kim Dunleavy, PhD
principal investigator · University of Florida

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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