Participatory ergonomics for the primary prevention of back and neck pain: a cost-effectiveness study

ISRCTN	ISRCTN27472278
DOI	https://doi.org/10.1186/ISRCTN27472278
Protocol serial number	N/A
Sponsor	VU University Medical Centre (The Netherlands)
Funder	The Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Submission date: 07/03/2007
Registration date: 07/03/2007
Last edited: 03/01/2012

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Mr Maurice Driessen, MSc
Scientific

EMGO-instituut
Van der Boechorststraat 7
Amsterdam
1081 BT
Netherlands

Phone	+31 (0)20 444 1710
Email	m.driessen@vumc.nl

Study information

Primary study design	Interventional
Study design	Randomised placebo controlled parallel group multicentre trial
Secondary study design	Randomised controlled trial
Scientific title
Study objectives	Is the participatory ergonomics program for workers without back or neck pain in the previous year, effective in the prevention of back and/or neck pain.
Ethics approval(s)	Approval received from the Medical Ethical Committee of the VU Medical Centre on the 1st January 2007.
Health condition(s) or problem(s) studied	Back and neck pain
Intervention	The intervention is a participative ergonomic program. The participative ergonomics apporoach is based on the active participation and strong commitment of the employer and employee in the process to identify (potential) risk factors in the workplace and to choose the most appropriate solutions for these risks. The program consists of six steps including a workplace observation, interviews and two meetings of one and five hours with (representatives of) workers and management from a department.
Intervention type	Other
Primary outcome measure(s)	The primary outcome measure is the incidence of back and/or neck pain in the year of follow-up, assessed by means of a postal questionnaire. In the baseline and follow-up questionnaires, data on the incidence of back and neck pain will be collected using an adapted version of the Nordic Questionnaire. Cases of back and/or neck pain will be defined as those workers who reported regular of prolonged back pain and/or neck pain in the previous 12 months.
Key secondary outcome measure(s)	Secondary outcome measures are: 1. Functional status 2. Pain intensity and sickness absence 3. Use of ergonomic measures Data on sickness absence will be collected on the basis of company and occupational health services registers. With respect to the economic evaluation data related to direct and indirect costs (costs in paid and unpaid labor as a consequence of sick leave or disability) and quality of life will be collected
Completion date	01/10/2008

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	All
Target sample size at registration	3668
Key inclusion criteria	1. Working more than 20 hours a week 2. More than one year employed
Key exclusion criteria	Workers with back and or neck pain in the three months prior to the intervention will be excluded.
Date of first enrolment	01/10/2007
Date of final enrolment	01/10/2008

Locations

Countries of recruitment

Netherlands

Study participating centre

EMGO-instituut

Amsterdam
1081 BT
Netherlands

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results	24/08/2010	Yes	No
Results article	results	01/09/2011	Yes	No
Results article	results	01/09/2011	Yes	No