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Chronic Low Back PainNCT03524378

Modifiable Work and Movement Solutions Low Back Pain in Seafood Workers

A study testing Ergonomic and movement modifications in people with Chronic Low Back Pain, run by University of Florida at 2 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages 18 to 60 years
Conditions the study is for
Chronic Low Back Pain
What is being tested?
Ergonomic and movement modifications
Could I receive a placebo?
No, everyone receives an active treatment
How many people
37 participants
Where
2 sitesUnited States
Study dates
1 Jun 2018to 29 Oct 2022
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 60 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

2 sites in 1 country.

United States2 sites
  • Cedar Key Aquaculture Association

    Cedar Key, Florida, 32625

  • UF Health

    Gainesville, Florida, 32611

Other trials in United States

About this study

Official title: Chronic Low Back Pain in Seafood Workers: a Pilot Intervention Study to Identify Modifiable Work and Movement Solutions

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.
Being tested
Ergonomic and movement modifications
Keywords
repetitive strain, ergonomics, participatory ergonomics, chronic low back pain, seafood workers

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Ergonomic and movement modificationsBehavioural

    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.

Study groups in NCT03524378
Study groupRoleWhat they receive
Ergonomic and movement modificationsOtherNo group assignment - all participants will self select suitable ergonomic or movement modifications
Receives: Behavioral: Ergonomic and movement modifications

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 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

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

Secondary outcomes (5)
  1. Short form pain anxiety symptom scale

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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Baseline, at 4 weeks and after intervention at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 May 2018
  2. Study start1 Jun 2018
  3. Primary completion29 Oct 2022
  4. Study completion29 Oct 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Within-subject control
Masking
None (open label)
Enrolment
37 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03524378
Sponsor's protocol ID
IRB201702245 - N
Other IDs
3U54OH011230-02S1, 6U54OH011230-05M002
Status last verified
Nov 2022
First submitted
20 Apr 2018
Last updated
17 Nov 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

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

Questions about this trial

What is this clinical trial studying?

A study testing Ergonomic and movement modifications in people with Chronic Low Back Pain, run by University of Florida at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Nov 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patient Specific Functional Scale (time frame: Change from baseline average measured over 4 weeks, after 4 and 8 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03524378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Nov 2022.

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