Assessment of socioeconomic impact of rheumatological care to patients with temporary work disability of musculoskeletal origin

ISRCTN ISRCTN38768940
DOI https://doi.org/10.1186/ISRCTN38768940
Secondary identifying numbers FIS 98/1050
Submission date
01/06/2007
Registration date
27/06/2007
Last edited
27/06/2007
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

Dr Juan Angel Jover
Scientific

Servicio de Reumatología
Hospital Clínico San Carlos
C/ Martín Lagos, s/n
Madrid
28040
Spain

Phone +34 91 330 36 15
Email jjover.hcsc@salud.madrid.org

Study information

Study designRandomized, controlled study, unblinded for both patients and physicians, of two years duration (recruitment one year, follow-up one year)
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study acronymIT-ME-98
Study objectivesA population-based, clinical program offered to patients with recent-onset work disability caused by Musculoskeletal Disorders (MSDs) is cost-effective with respect to standard care.
Ethics approval(s)The study protocol was approved by the institutional review board of the Hospital Clínico San Carlos and reviewed by the Fondo de Investigaciones Sanitarias (the research agency of the Ministry of Health). Date of approval June 2, 1998.
Health condition(s) or problem(s) studiedMusculoskeletal disorders causing temporary work disability.
InterventionThe intervention was a specific clinical program. The control group received standard care.

At the first 45-minute visit, patients received a specific diagnosis, reassurance that no serious disease was present, instructions on self-management, instructions on taking medications on a fixed schedule, and information on indications for return to work before complete symptom remission. Return to work was negotiated with patients and was never forced on them. Instructions on self-management included instructions to avoid bed rest, instructions to promote early mobilization of the painful regions, restrictions on the use of splint and neck collars, training in stretching and strengthening exercises, teaching of ergonomic care, delivery of booklets in instances of back or neck pain, and information on optimal levels of physical activity. Patients with higher degrees of disability or abnormal pain behavior received immediate extra reassurance, information on pain-relieving positions, and a telephone call or second visit within 72 hours.

Specific protocols were created for low-back, neck, shoulder, arm and hand, knee, and foot pain and included the three-level clinical-management system described below. Moving a patient from the lower to the upper levels of the system implied the need for further diagnostic or therapeutic procedures and was indicated 1) after a patient spent a predefined period at the lower level without return to work or substantial clinical improvement or 2) by the clinical judgment of the rheumatologist.

At the first level of the system, patients received the clinical management started at the first visit, including a diagnosis based on clinical criteria, pharmacologic treatment of pain and inflammation, pharmacologic treatment of anxiety and depression, peripheral intra- and periarticular injections, and education. Time spent at the first level averaged 2 to 6 weeks. At the second level, patients received maintenance of therapy plus referral for formal rehabilitation and laboratory tests, radiography, computerized tomography, magnetic resonance imaging, and electromyography. After 4 to 8 weeks with no improvement at the second level, patients were moved to the third level and received further diagnostic procedures or referral for surgical or other specialized care. “Red flags” were defined, including age greater than 50 years for patients with axial pain, previous trauma, cancer, serious medical illness, inflammatory pain, night pain, drug abuse, corticosteroid use, fever, weight loss, progressively deteriorating function, and progressive neurologic deficit. The presence of a red flag precluded the use of the level system, and the patient in question was managed according to clinical criteria, with a focus on excluding serious illness.
Intervention typeOther
Primary outcome measureEfficacy was defined as the differences between groups in the following:
1. Duration of all episodes of MSD-related temporary work disability
2. Number of episodes of MSD-related temporary work disability per patient, assessed one year after the end of inclusion period
3. Number and outcome of proposals for permanent work disability
Secondary outcome measures1. Relative efficacy is expressed as the percentage of days on temporary work disability saved per patient and as the total number of days on temporary work disability saved in the intervention group (number of episodes in the intervention group x [mean duration of episodes in control group - mean duration of episodes in intervention group]).
2. Cost-efficacy was defined as the amount of money required to save 1 day of temporary work disability.
3. Cost-benefit was defined as dollars invested divided by dollars saved.
Net benefit was defined as dollars saved minus dollars invested.
Overall study start date01/03/1998
Completion date01/03/2001

Eligibility

Participant type(s)Patient
Age groupAdult
SexBoth
Target number of participants13077 (7805 in control group and 5272 in intervention group)
Key inclusion criteriaThe issue of a “common diseases” temporary work disability initiation form, with an MSD-related cause reported by the primary care physician. The MSD-related causes included the following:
1. All arthropathies
2. Connective tissue disorders
3. Back disorders
4. Soft-tissue rheumatisms
5. Bone and cartilage disorders
6. Musculoskeletal pain not caused by cancer
7. Nerve entrapment syndromes
Key exclusion criteria1. Patients who had “common diseases” temporary work disability form with an MSD-related cause resulting from trauma or surgery.
2. Patients who had “work accidents” or “professional diseases” noted on the temporary work disability initiation form. Work accidents are primarily sudden, external, violent causes of disease occurring at work or during travel to work, and they represent less than 27% of cases of temporary work disability. Professional diseases include silicosis, asbestos-related mesotelioma, and noise-induced hearing loss, and they represent less than 1% of cases of temporary work disability.
Date of first enrolment01/03/1998
Date of final enrolment01/03/2001

Locations

Countries of recruitment

  • Spain

Study participating centre

Servicio de Reumatología
Madrid
28040
Spain

Sponsor information

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Government

C/ Sinesio Delgado
Nº 6 (Pabellón Nº 4)
Madrid
28029
Spain

Phone +34 91 822 21 00
Email Oficina.informacion@isciii.es
Website http://www.isciii.es/htdocs/en/investigacion/investigacion_presentacion.jsp
ROR logo "ROR" https://ror.org/00ca2c886

Funders

Funder type

Government

Research Funding Agency of the Spanish Ministry of Health (Fondo de Investigación Sanitaria; FIS)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article Results: 20/09/2005 Yes No
Results article Results: 15/03/2007 Yes No