Condition category
Musculoskeletal Diseases
Date applied
04/04/2008
Date assigned
30/04/2008
Last edited
06/02/2013
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Marie Birk Jørgensen

ORCID ID

Contact details

Lersø Parkallé 105
Copenhagen Ø
2100
Denmark
+45 39 16 53 46
mbj@arbejdsmiljoforskning.dk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

TKIF2006-018

Study information

Scientific title

Preventing deterioration among cleaners

Acronym

FINALE 4

Study hypothesis

1. Physical coordination training reduces shoulder and neck pain in cleaners
2. Physical coordination training is more effective than cognitive behavioural training in reducing pain in the short term (months)
3. Cognitive behavioural training is more effective than physical coordination training in increasing physical activity in the long term (years)

Ethics approval

Ethics approval received from the Committees on Biomedical Research Ethics of the Capital Region of Denmark on the 13th May 2008 (ref: H-C-2007-0033).

Study design

Cluster randomised controlled intervention trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Shoulder and neck pain

Intervention

Participants are randomised in clusters related to their team at the workplace to receive one of the following for one year:

1. Physical coordination training:
Three weekly training sessions at the work place of 20 minutes duration is offered to the participants during the first three months of intervention. The training persists of physically hard exercises that demands high activation of stabilising muscles around the trunk and shoulder girdle. The amount of training sessions is slowly reduced during the subsequent three months and during the last six months, there will only be one meeting every month, where the participants are introduced to new interesting types of physical activity.

2. Cognitive behavioural training:
Two monthly training sessions at the work place of two hours duration is offered to the participants during the first three months of intervention. The training persists of information and cognitive exercises regarding biological causes of pain, differentiation between pain and injury, and strategies for relaxation. The amount of training sessions is reduced to one every month during three months and then the duration of the sessions is reduced to one hour per session during the last six months. Here the participants' success with training cognitively and behaviourally is evaluated and the participants receive help to proceed.

3. Health check (control):
The reference group receives one health check during the whole one year intervention period of one-hour duration. The health check is given in order to give the participants a feeling of output for their participation in the tests and questionnaires. The health check includes pulmonary-function test and fitness test. The results are given to the participants but no instruction is given regarding treatment, unless it is ethically irresponsible.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Sick leave, obtained through participating companies annual registrations
2. Work ability, measured using the Work Ability Index Questionnaire (developed by the Finnish Institute of Occupational Health)

Both primary and secondary outcomes will be measured before the intervention (timepoint 1 [Oct/Nov 2008]), after the first intensive intervention period (timepoint 2 [Jan/Feb 2009]) and after the one-year intervention (timepoint 3 [Oct/Nov 2009]).

Secondary outcome measures

1. Musculoskeletal pain, measured using the Nordic Council of Ministers quiestionnaire on musculoskeletal complaints
2. Physical capacity (strength, coordination), measured as isometric maximal voluntary contraction in four exercises:
2.1. Trunk flexion
2.2. Trunk extension
2.3. Shoulder lift
2.4. Shoulder abduction
As a measure of postural sway on a force platform and as a measure of stability in a force steadiness exercise for the shoulder muscles
3. Kinesiophobia

Both primary and secondary outcomes will be measured before the intervention (timepoint 1 [Oct/Nov 2008]), after the first intensive intervention period (timepoint 2 [Jan/Feb 2009]) and after the one-year intervention (timepoint 3 [Oct/Nov 2009]).

Overall trial start date

01/08/2007

Overall trial end date

01/12/2010

Reason abandoned

Eligibility

Participant inclusion criteria

1. Cleaners at larger cleaning departments
2. Aged 18 - 65 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

400

Participant exclusion criteria

1. Angina pectoris
2. Pregnancy
3. Life-threatening diseases

Recruitment start date

01/08/2007

Recruitment end date

01/12/2010

Locations

Countries of recruitment

Denmark

Trial participating centre

Lersø Parkallé 105
Copenhagen Ø
2100
Denmark

Sponsor information

Organisation

The Ministry of Culture Committee on Sports Research (Denmark)

Sponsor details

H.C. Andersens Boulevard 2
København V
1553
Denmark
+45 33 74 55 52
evajen@kumadm.dk

Sponsor type

Government

Website

http://www.kumadm.dk/sw69098.asp

Funders

Funder type

Government

Funder name

The Ministry of Culture Committee on Sports Research (Denmark) (ref: TKIF2006-018)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

1. 2010 protocol in http://www.ncbi.nlm.nih.gov/pubmed/20214807
2. 2010 results in http://www.ncbi.nlm.nih.gov/pubmed/20546592
3. 2011 results in http://www.ncbi.nlm.nih.gov/pubmed/21985226
4. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22356733

Publication citations

  1. Protocol

    Holtermann A, Jørgensen MB, Gram B, Christensen JR, Faber A, Overgaard K, Ektor-Andersen J, Mortensen OS, Sjøgaard G, Søgaard K, Worksite interventions for preventing physical deterioration among employees in job-groups with high physical work demands: background, design and conceptual model of FINALE., BMC Public Health, 2010, 10, 120, doi: 10.1186/1471-2458-10-120.

  2. Results

    Jørgensen MB, Rasmussen CD, Ekner D, Søgaard K, Successful reach and adoption of a workplace health promotion RCT targeting a group of high-risk workers., BMC Med Res Methodol, 2010, 10, 56, doi: 10.1186/1471-2288-10-56.

  3. Results

    Jørgensen MB, Ektor-Andersen J, Sjøgaard G, Holtermann A, Søgaard K, A randomised controlled trial among cleaners--effects on strength, balance and kinesiophobia., BMC Public Health, 2011, 11, 776, doi: 10.1186/1471-2458-11-776.

  4. Results

    Jespersen T, Jørgensen MB, Hansen JV, Holtermann A, Søgaard K, The relationship between low back pain and leisure time physical activity in a working population of cleaners--a study with weekly follow-ups for 1 year., BMC Musculoskelet Disord, 2012, 13, 28, doi: 10.1186/1471-2474-13-28.

Additional files

Editorial Notes