Effectiveness of early part-time sick leave in musculoskeletal disorders

Plain English Summary

Not provided at time of registration

Study website

http://www.ttl.fi/osasairausvapaahanke

Type

Scientific

Contact name

Prof Eira Viikari-Juntura

ORCID ID

Contact details

Topeliuksenkatu 41 a A
Helsinki
00250
Finland
eira.viikari-juntura@ttl.fi

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

322139

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(s)

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

Study setting(s)

Not specified

Study 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

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 study start date

01/01/2008

Overall study end date

30/06/2009

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(s)

Patient

Age group

Adult

Lower age limit

18 Years

Sex

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

Countries of recruitment

Finland

Study participating centre

Topeliuksenkatu 41 a A
Helsinki
00250
Finland

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

http://www.ttl.fi/internet/english

ROR

https://ror.org/030wyr187

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

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs