NCT02498197

Brief Summary

There is high prevalence of back pain and neck-shoulder pain among blue collar workers. Physical excessive exposures such as heavy lifting or working with a bended or twisted back are independent risk factors for back pain among workers in the construction industry. Participatory ergonomic initiatives increase the success of interventions aimed at reducing physical excessive exposures. The objectives are in two phases to; 1) determine which work-tasks in selected job-groups involve the highest load of the back and shoulders during a normal working day (using EMG, Actigraphs, Video). 2) investigate whether a participatory intervention can reduce physical workloads, drawing on information from objective measurements from phase 1.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
80

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2016

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 29, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

July 15, 2015

Completed
8 months until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2017

Completed
Last Updated

August 13, 2018

Status Verified

August 1, 2018

Enrollment Period

1.3 years

First QC Date

June 29, 2015

Last Update Submit

August 10, 2018

Conditions

Musculoskeletal Disorders

Outcome Measures

Primary Outcomes (1)

  • Excessive physical load

    The primary outcome of the present study is the change from baseline to follow-up in frequency of events with excessive physical load

    change from baseline to 3 months follow-up

Secondary Outcomes (3)

  • Pain intensity (0-10)

    change from baseline to 3 months follow-up

  • WAI questionnaire

    change from baseline to 3 months follow-up

  • Self-efficacy Questionnaire

    change from baseline to 3 months follow-up

Other Outcomes (1)

  • Social Capital questionnaire

    change from baseline to 3 months follow-up

Study Arms (2)

Participatory Intervention

EXPERIMENTAL

Participatory intervention with workers and their leaders. Workshops with presentation of work tasks with excessive physical load and subsequently plans to reduce these loads

Behavioral: Participatory Intervention

Control

ACTIVE COMPARATOR

Receive standard information about correct lifting technics, use of assistive technology, and ergonomics

Behavioral: Control

Interventions

Participatory InterventionBEHAVIORAL
Participatory Intervention
ControlBEHAVIORAL
Control

Eligibility Criteria

Age18 Years - 67 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Full time construction workers who are member of a labor union and can read and understand Danish.
  • The type of work must include manual work that involves lifting

You may not qualify if:

  • life-threatening diseases
  • pregnancy
  • hypertension \>160/100 mmHg
  • unable to participate in the measurements

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Research Centre for the Working Environment

Copenhagen, 2100, Denmark

Location

Related Publications (2)

  • Brandt M, Madeleine P, Samani A, Ajslev JZ, Jakobsen MD, Sundstrup E, Andersen LL. Effects of a Participatory Ergonomics Intervention With Wearable Technical Measurements of Physical Workload in the Construction Industry: Cluster Randomized Controlled Trial. J Med Internet Res. 2018 Dec 19;20(12):e10272. doi: 10.2196/10272.

    PMID: 30567694DERIVED

  • Brandt M, Madeleine P, Ajslev JZ, Jakobsen MD, Samani A, Sundstrup E, Kines P, Andersen LL. Participatory intervention with objectively measured physical risk factors for musculoskeletal disorders in the construction industry: study protocol for a cluster randomized controlled trial. BMC Musculoskelet Disord. 2015 Oct 16;16:302. doi: 10.1186/s12891-015-0758-0.

    PMID: 26474867DERIVED

MeSH Terms

Conditions

Musculoskeletal Diseases

Study Officials

  • Lars L Andersen, PhD

    National Research Centre for the Working Environment, Denmark

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, PhD

Study Record Dates

First Submitted

June 29, 2015

First Posted

July 15, 2015

Study Start

March 1, 2016

Primary Completion

June 1, 2017

Study Completion

December 1, 2017

Last Updated

August 13, 2018

Record last verified: 2018-08

Locations

DK(1)