Condition category
Musculoskeletal Diseases
Date applied
Date assigned
Last edited
Retrospectively registered
Overall trial status
Recruitment status
No longer recruiting
Publication status

Plain English Summary

Not provided at time of registration

Trial website

Contact information



Primary contact

Prof Eira Viikari-Juntura


Contact details

Topeliuksenkatu 41 a A

Additional identifiers

EudraCT number number

Protocol/serial number


Study information

Scientific title


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


Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Patient information in Finnish:


Musculoskeletal disorders


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



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


Overall trial end date


Reason abandoned (if study stopped)


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


Age group




Target number of participants


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


Recruitment end date



Countries of recruitment


Trial participating centre

Topeliuksenkatu 41 a A

Sponsor information


Finnish Institute of Occupational Health

Sponsor details

Topeliuksenkatu 41 a A
+358 (0)30 4741

Sponsor type

Research organisation



Funder type


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


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
2. 2012 results in
3. 2013 results in

Publication citations

  1. 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.

  2. 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.

  3. 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.

Additional files

Editorial Notes