|- candidate number||2471|
|- NTR Number||NTR906|
|- Date ISRCTN created||7-mrt-2007|
|- date ISRCTN requested||6-mrt-2007|
|- Date Registered NTR||16-feb-2007|
|- Secondary IDs||N/A |
|- Public Title||Participatory ergonomics for the primary prevention of back and neck pain; a cost-effectiveness study.|
|- Scientific Title||Participatory ergonomics for the primary prevention of back and neck pain; a cost-effectiveness study.|
|- hypothesis||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. |
|- Healt Condition(s) or Problem(s) studied||Neck complaints, Prevention, Participatory ergonomics, Back pain, Workers|
|- Inclusion criteria||1. Working more than 20 hours a week;|
2. more than one year employed.
|- Exclusion criteria||1. Workers with back and or neck pain in the 3 months prior to the intervention will be excluded.|
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-okt-2007|
|- planned closingdate||1-okt-2008|
|- Target number of participants||3668|
|- Interventions||The interventions 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 out of six steps including a workplace observation, interviews and two meetings of 1,5 hours with (representatives of) workers and management of a department. |
|- Primary outcome||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. |
|- Secondary outcome||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 tot the economic evaluation data related to direct and indirect costs (costs in paid and unpaid labor as a consequence of sickleave or disability) and quality of life will be collected.
|- Trial web site||N/A|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| Maurice Driessen|
|- CONTACT for SCIENTIFIC QUERIES||Dr. Han J.R. Anema|
|- Sponsor/Initiator ||VU University Medical Center, EMGO+ Institute|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Summary|
Low back and neck pain are the most common and expensive musculoskeletal disorders in Western countries. Physical and psychosocial factors in the workplace have been identified as risk factors for back and neck pain. However, the (cost)effectiveness of ergonomic programs for the primary prevention of back or neck pain has not been evaluated yet in a well designed study.
To evaluate the (cost-)effectiveness of a participatory ergonomics intervention to prevent back and/or neck pain in workers.
Design Randomized controlled trial with two arms; Randomization of workers to the participatory ergonomics program takes place on the level of departments to avoid contamination between workers receiving the intervention or not (n=2x1027).
Intervention The intervention is based on a structured method with active participation of both the workers and management. After an ergonomic evaluation, risk factors in the workplace will be identified and most appropriate ergonomic solutions will be chosen in a meeting on a consensus basis. In addition, all the workers (including controls) receive a movie in prevention of musculoskeletal disorders.
At least 2568 workers will be recruited in collaboration with KLM Health Services, Occupational Health Services of VU/VU Medical Center and the 'Nederlandse Spoorwegen'. Inclusion criteria for workers to participate are: working for more than 20 hours a week and employed for more than one year. Workers who have had neck and/or back pain in the past 12 months, will be excluded.
Primary outcome measure is the incidence of back and/or neck pain in the year of the follow-up.
Secondary outcome measures are:
Functional status, Pain intensity (10-point scale), sickness absense, direct and indirect costs and quality of life.
Measurements are at baseline, 26 and 52 weeks after start of the intervention.
Back and neck pain; prevention; participatory ergonomics; cost-effectiveness.
|- Main changes (audit trail)|
|- RECORD||16-feb-2007 - 15-mei-2008|