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Modifiable Work and Movement Solutions Low Back Pain in Seafood Workers

Primary Purpose

Chronic Low Back Pain

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ergonomic and movement modifications
Sponsored by
University of Florida
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Low Back Pain focused on measuring repetitive strain, ergonomics, participatory ergonomics, chronic low back pain, seafood workers

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Cedar Key Aquaculture Association
  • UF Health

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

Ergonomic and movement modifications

Arm Description

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

Outcomes

Primary Outcome Measures

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.
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

Secondary Outcome Measures

Short form pain anxiety symptom scale
Self reported survey to reflect anxiety (Ranges from 0-5 with 5 being always in pain)
Fear avoidance single item question
Single item question to reflect fear avoidance measured as both a co-variate or possible outcome
Pain self-efficacy questions
Two questions to reflect fear avoidance measured as both a co-variate or outcome
Pain coping questions
Two questions to reflect fear avoidance measured as both a co-variate or outcome
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

Full Information

First Posted
April 20, 2018
Last Updated
November 14, 2022
Sponsor
University of Florida
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)
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1. Study Identification

Unique Protocol Identification Number
NCT03524378
Brief Title
Modifiable Work and Movement Solutions Low Back Pain in Seafood Workers
Official Title
Chronic Low Back Pain in Seafood Workers: a Pilot Intervention Study to Identify Modifiable Work and Movement Solutions
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2018 (Actual)
Primary Completion Date
October 29, 2022 (Actual)
Study Completion Date
October 29, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Florida
Collaborators
National Institute for Occupational Safety and Health (NIOSH/CDC)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Low Back Pain
Keywords
repetitive strain, ergonomics, participatory ergonomics, chronic low back pain, seafood workers

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Within-subject control
Masking
None (Open Label)
Allocation
N/A
Enrollment
37 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ergonomic and movement modifications
Arm Type
Other
Arm Description
No group assignment - all participants will self select suitable ergonomic or movement modifications
Intervention Type
Behavioral
Intervention Name(s)
Ergonomic and movement modifications
Intervention Description
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.
Primary Outcome Measure Information:
Title
Patient Specific Functional Scale
Description
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
Title
Pain rating scales
Description
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 Outcome Measure Information:
Title
Short form pain anxiety symptom scale
Description
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
Title
Fear avoidance single item question
Description
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
Title
Pain self-efficacy questions
Description
Two questions to reflect fear avoidance measured as both a co-variate or outcome
Time Frame
Baseline, Day 1, 4 weeks, 8 weeks
Title
Pain coping questions
Description
Two questions to reflect fear avoidance measured as both a co-variate or outcome
Time Frame
Baseline, Day 1, 4 weeks, 8 weeks
Title
Oswestry Disability Index for low back pain
Description
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 Pre-specified Outcome Measures:
Title
Adoption of strategies
Description
Number of individuals adopting work-related methods for more than 50% of the time
Time Frame
8 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: History of chronic low back pain Employed full time in clam harvesting/processing Exclusion Criteria: History of spinal surgery in past 3 years Recent hospitalization in the past year for any condition Subjects currently seeking disability
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kim Dunleavy, PhD
Organizational Affiliation
University of Florida
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cedar Key Aquaculture Association
City
Cedar Key
State/Province
Florida
ZIP/Postal Code
32625
Country
United States
Facility Name
UF Health
City
Gainesville
State/Province
Florida
ZIP/Postal Code
32611
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
34772318
Citation
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.
Results Reference
derived

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Modifiable Work and Movement Solutions Low Back Pain in Seafood Workers

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