Effectiveness of early part-time sick leave in musculoskeletal disorders
| ISRCTN | ISRCTN30911719 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN30911719 |
| Secondary identifying numbers | 322139 |
- 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
Scientific
Topeliuksenkatu 41 a A
Helsinki
00250
Finland
| eira.viikari-juntura@ttl.fi |
Study information
| 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 |
| Participant information sheet | Patient information in Finnish: http://www.ttl.fi/osasairausvapaa |
| 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 | 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 |
| Completion date | 30/06/2009 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 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
00250
Finland
Sponsor information
Finnish Institute of Occupational Health
Research organisation
Research organisation
Topeliuksenkatu 41 a A
Helsinki
00250
Finland
| Phone | +358 (0)30 4741 |
|---|---|
| eira.viikari-juntura@ttl.fi | |
| Website | http://www.ttl.fi/internet/english |
"ROR" |
https://ror.org/030wyr187 |
Funders
Funder type
Government
Ministry of Social Affairs and Health, Social Insurance Department, the Finnish Work Environment Fund (ref. 106304)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 25/02/2008 | Yes | No | |
| Results article | results | 01/03/2012 | Yes | No | |
| Results article | results | 01/01/2013 | Yes | No |
