Contact information
Type
Scientific
Primary contact
Dr Juan Angel Jover
ORCID ID
Contact details
Servicio de Reumatología
Hospital Clínico San Carlos
C/ Martín Lagos
s/n
Madrid
28040
Spain
+34 91 330 36 15
jjover.hcsc@salud.madrid.org
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
FIS 98/1050
Study information
Scientific title
Acronym
IT-ME-98
Study hypothesis
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
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.
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
Trial setting
Not specified
Trial type
Not Specified
Patient information sheet
Condition
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
Phase
Not Specified
Drug names
Primary outcome measures
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 trial start date
01/03/1998
Overall trial end date
01/03/2001
Reason abandoned
Eligibility
Participant 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
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
13077 (7805 in control group and 5272 in intervention group)
Participant 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.
Recruitment start date
01/03/1998
Recruitment end date
01/03/2001
Locations
Countries of recruitment
Spain
Trial participating centre
Servicio de Reumatología
Madrid
28040
Spain
Sponsor information
Organisation
The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain)
Sponsor details
C/ Sinesio Delgado
Nº 6 (Pabellón Nº 4)
Madrid
28029
Spain
+34 91 822 21 00
Oficina.informacion@isciii.es
Sponsor type
Government
Website
http://www.isciii.es/htdocs/en/investigacion/investigacion_presentacion.jsp
Funders
Funder type
Government
Funder name
Research Funding Agency of the Spanish Ministry of Health (Fondo de Investigación Sanitaria; FIS)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16172439
Results: http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=17330282
Publication citations
-
Results
Abásolo L, Blanco M, Bachiller J, Candelas G, Collado P, Lajas C, Revenga M, Ricci P, Lázaro P, Aguilar MD, Vargas E, Fernández-Gutiérrez B, Hernández-García C, Carmona L, Jover JA, A health system program to reduce work disability related to musculoskeletal disorders., Ann. Intern. Med., 2005, 143, 6, 404-414.
-
Results
Abásolo L, Carmona L, Hernández-García C, Lajas C, Loza E, Blanco M, Candelas G, Fernández-Gutiérrez B, Jover JA, Musculoskeletal work disability for clinicians: time course and effectiveness of a specialized intervention program by diagnosis., Arthritis Rheum., 2007, 57, 2, 335-342, doi: 10.1002/art.22529.