Effectiveness of early part-time sick leave in musculoskeletal disorders

ISRCTN	ISRCTN30911719
DOI	https://doi.org/10.1186/ISRCTN30911719
Protocol serial number	322139
Sponsor	Finnish Institute of Occupational Health
Funder	Ministry of Social Affairs and Health, Social Insurance Department, the Finnish Work Environment Fund (ref. 106304)

Submission date: 19/12/2007
Registration date: 21/01/2008
Last edited: 26/06/2013

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Eira Viikari-Juntura
Scientific

Topeliuksenkatu 41 a A
Helsinki
00250
Finland

Email	eira.viikari-juntura@ttl.fi

Study information

Primary study design	Interventional
Study design	Single-center randomized controlled trial
Secondary study design	Randomised controlled trial
Study type	Participant information sheet
Scientific title
Study objectives	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.
Health condition(s) or problem(s) studied	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(s)	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
Key secondary outcome measure(s)	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.
Completion date	30/06/2009

Eligibility

Participant type(s)	Patient
Age group	Adult
Lower age limit	18 Years
Sex	All
Target sample size at registration	600
Key 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
Key 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
Date of first enrolment	01/01/2008
Date of final enrolment	30/06/2009

Locations

Countries of recruitment

Finland

Study participating centre

Topeliuksenkatu 41 a A

Helsinki
00250
Finland

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/03/2012		Yes	No
Results article	results	01/01/2013		Yes	No
Protocol article	protocol	25/02/2008		Yes	No
Participant information sheet	Participant information sheet	11/11/2025	11/11/2025	No	Yes
Study website	Study website	11/11/2025	11/11/2025	No	Yes