Modifiable Work and Movement Solutions Low Back Pain in Seafood Workers

NCT03524378 | Completed

• 3 other identifiers: IRB201702245 - N3U54OH011230-02S16U54OH011230-05M002
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 2

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.

Conditions

Chronic Low Back Pain

Keywords

repetitive strain; ergonomics; participatory ergonomics; chronic low back pain; seafood workers

Outcome Measures

Primary Outcomes (2)

• 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.

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

• 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

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

Secondary Outcomes (5)

• Short form pain anxiety symptom scale

  Baseline, Day 1, 4 weeks, 8 weeks

• Fear avoidance single item question

  Baseline, Day 1, 4 weeks, 8 weeks

• Pain self-efficacy questions

  Baseline, Day 1, 4 weeks, 8 weeks

• Pain coping questions

  Baseline, Day 1, 4 weeks, 8 weeks

• Oswestry Disability Index for low back pain

  Baseline, at 4 weeks and after intervention at 8 weeks

Other Outcomes (1)

• Adoption of strategies

  8 weeks

Study Arms (1)

Ergonomic and movement modifications

OTHER

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

Behavioral: Ergonomic and movement modifications

Interventions

Ergonomic and movement modifications BEHAVIORAL

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.

Ergonomic and movement modifications

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Florida: lead
• National Institute for Occupational Safety and Health (NIOSH/CDC): collaborator

Study Sites (2)

Cedar Key Aquaculture Association

Cedar Key, Florida, 32625, United States

Location

UF Health

Gainesville, Florida, 32611, United States

Location

Related Publications (1)

• 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.

  PMID: 34772318 DERIVED

MeSH Terms

Interventions

Ergonomics

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture

Study Officials

• Kim Dunleavy, PhD

  University of Florida

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Within-subject control

Study Record Dates

• First Submitted: April 20, 2018
• First Posted: May 14, 2018
• Study Start: June 1, 2018
• Primary Completion: October 29, 2022
• Study Completion: October 29, 2022
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)