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 design	Randomized, controlled study, unblinded for both patients and physicians, of two years duration (recruitment one year, follow-up one year)
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study acronym	IT-ME-98
Study objectives	A 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) studied	Musculoskeletal disorders causing temporary work disability.
Intervention	The 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 type	Other
Primary outcome measure	Efficacy 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 measures	1. 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 date	01/03/1998
Completion date	01/03/2001

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	13077 (7805 in control group and 5272 in intervention group)
Key inclusion criteria	The 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 criteria	1. 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 enrolment	01/03/1998
Date of final enrolment	01/03/2001

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"	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 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?
Results article	Results:	20/09/2005		Yes	No
Results article	Results:	15/03/2007		Yes	No