Plain English Summary
Not provided at time of registration
Trial website
Contact information
Type
Scientific
Primary contact
Prof Eira Viikari-Juntura
ORCID ID
Contact details
Topeliuksenkatu 41 a A
Helsinki
00250
Finland
eira.viikari-juntura@ttl.fi
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
322139
Study information
Scientific title
Acronym
Study hypothesis
Our hypothesis is that employees whose work time is temporarily reduced and work load adjusted during early stage of disability will have less disability days and faster return to regular work duties than employees on conventional sick leave.
Ethics approval
Approved by the Coordinating Ethics Committee of Hospital District of Helsinki and Uusimaa on 20 December 2005 (HUS 461/E0/05). Amendment was approved on 24 October 2006.
Study design
Single-center randomized controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Patient information in Finnish: http://www.ttl.fi/osasairausvapaa
Condition
Musculoskeletal disorders
Intervention
Intervention: Part-time sick leave (daily work load reduced by restricting work time by about 50%, and, if necessary, remaining work tasks modified so that working should be possible despite the symptoms)
Control: Full-time sick leave
Intervention type
Other
Phase
Not Specified
Drug names
Primary outcome measure
1. Number of days from the initial visit to the return to regular work activities
2. Total number of part- and full-time sick leave days during one- and two-year follow-up
Secondary outcome measures
1. Pain, measured using numerical scale 0 to 10 (0 = no pain, 10 = unbearable pain) at 0, 1, 3, 8, 12 and 52 weeks
2. Self-assessed function (Oswestry back questionnaire; shortened Disabilities of the Arm, Shoulder and Hand questionnaire [Quick DASH]; Comprehensive OsteoArthritis Test [COAT]) at 0, 1, 3, 8, 12 and 52 weeks
Costs and benefits to the employee, employer and society will be estimated in both study groups.
Overall trial start date
01/01/2008
Overall trial end date
30/06/2009
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Employees who seek medical advice in the occupational health service primarily due to musculoskeletal pain in the neck or shoulder region, back or upper or lower extremities, are eligible to the study. The symptoms and related disability must warrant prescription of full-time sick leave according to the current practice, but the physician considers the employee to be able to work part-time without the risk of the health condition to deteriorate.
Specific inclusion criteria:
1. 18 to 60 years of age
2. Permanent or long-term employment (30 hours or more per week)
3. No sick leave or other absence exceeding two weeks during the preceding month
4. Not more than 30 days on sick leave due to any health problem during three preceding months
5. Employee is not listed for any surgery that requires more than one week of sickness absence
6. No plan for longer absence from work during 12 months after enrollment
7. An employee can be enrolled only once
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
600
Participant exclusion criteria
1. General exclusion criteria:
1.1. Acute infections
1.2. Major accidental injury
1.3. Active inflammatory arthritis
1.4. Suspected occupational injury or disease
1.5. Malignant tumour diagnosed or treated during the preceding year
1.6. Severe mental disorder;
1.7. Pregnancy
1.8. Severe pain (>7 on a scale from 0 to 10)
1.9. Pain interferes with sleep severely (>7 on scale from 0 to 10)
Pain area specific exclusion criteria:
2. Back region:
2.1. Muscle weakness in the lower extremities related to back pain
2.2. Positive straight-leg-raising test
2.3. Pain-related trunk list
2.4. Painful spasm of the back when bending forward
3. Neck and shoulder region:
3.1. Muscle weakness in the upper extremities related to the pain
3.2. Head compression or movements induce radiating pain below elbow level
3.3. Painful torticollis
4. Shoulder and upper extremity regions:
4.1. Muscle weakness related to the pain
4.2. Severe pain in movements interfering with most functions
5. Lower extremities:
5.1. Pain prevents walking
Recruitment start date
01/01/2008
Recruitment end date
30/06/2009
Locations
Countries of recruitment
Finland
Trial participating centre
Topeliuksenkatu 41 a A
Helsinki
00250
Finland
Sponsor information
Organisation
Finnish Institute of Occupational Health
Sponsor details
Topeliuksenkatu 41 a A
Helsinki
00250
Finland
+358 (0)30 4741
eira.viikari-juntura@ttl.fi
Sponsor type
Research organisation
Website
Funders
Funder type
Government
Funder name
Ministry of Social Affairs and Health, Social Insurance Department, the Finnish Work Environment Fund (ref. 106304)
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
Basic results (scientific)
Publication list
1. 2008 protocol in http://www.ncbi.nlm.nih.gov/pubmed/18294405
2. 2012 results in http://www.ncbi.nlm.nih.gov/pubmed/22033811
3. 2013 results in http://www.ncbi.nlm.nih.gov/pubmed/22538838
Publication citations
-
Results
Viikari-Juntura E, Kausto J, Shiri R, Kaila-Kangas L, Takala EP, Karppinen J, Miranda H, Luukkonen R, Martimo KP, Return to work after early part-time sick leave due to musculoskeletal disorders: a randomized controlled trial., Scand J Work Environ Health, 2012, 38, 2, 134-143, doi: 10.5271/sjweh.3258.
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Results
Shiri R, Kausto J, Martimo KP, Kaila-Kangas L, Takala EP, Viikari-Juntura E, Health-related effects of early part-time sick leave due to musculoskeletal disorders: a randomized controlled trial., Scand J Work Environ Health, 2013, 39, 1, 37-45, doi: 10.5271/sjweh.3301.
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Martimo KP, Kaila-Kangas L, Kausto J, Takala EP, Ketola R, Riihimäki H, Luukkonen R, Karppinen J, Miranda H, Viikari-Juntura E, Effectiveness of early part-time sick leave in musculoskeletal disorders., BMC Musculoskelet Disord, 2008, 9, 23, doi: 10.1186/1471-2474-9-23.