Condition category
Musculoskeletal Diseases
Date applied
01/06/2007
Date assigned
27/06/2007
Last edited
27/06/2007
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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

  1. 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.

  2. 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.

Additional files

Editorial Notes