Condition category
Musculoskeletal Diseases
Date applied
06/06/2007
Date assigned
27/06/2007
Last edited
04/07/2007
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

Rheumatology
Hospital Clinico San Carlos
Martin Lagos s/n
Madrid
28040
Spain

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Early CBT in TWD-MSD (Temporary Work Disability-MusculoSkeletal Disorders)

Study hypothesis

To evaluate whether a Cognitive Behavioral Treatment (CBT), complementary to a rheumatologic specific program, offered to patients with poor evolution of work disability caused by musculoskeletal disorders (MSDs) is cost-effective.

Ethics approval

Ethics Committee of Clinical Investigation, Hospital Clínico San Carlos, approved on 30 June 2004 (ref: 0-04/139).

Study design

Randomized controlled study.

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Musculoskeletal disorders-related temporary work disability

Intervention

A psychologist will deliver CBT that is complementary to a rheumatologic specific program. One session lasts 45 minutes. The number of sessions is not previously fixed, and varies between 1 and a maximum of 8. The control group will receive standard care.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Efficacy was defined as the differences between groups in the following (assessed for each participant 6 months after inclusion into the study):
1. Duration of all MSD-TWD episodes
2. Number of MSD-TWD episodes per patient
3. Number or relapses of MSD-TWD episodes
4. Duration or relapses of MSD-TWD episodes
5. Number and outcome of proposal for permanent work disability

Secondary outcome measures

Cost measures

Overall trial start date

15/10/2004

Overall trial end date

15/04/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Musculoskeletal disorders-related temporary work disability for at least 3 weeks
2. Admitted to the rheumatologic specialized care

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

200

Participant exclusion criteria

Patients with more than 8 weeks MSD-related temporary work disability.

Recruitment start date

15/10/2004

Recruitment end date

15/04/2007

Locations

Countries of recruitment

Spain

Trial participating centre

Rheumatology
Madrid
28040
Spain

Sponsor information

Organisation

Musculoskeletal Disease Foundation and FREMAP Foundation

Sponsor details

Ercon Consultores
Calle Jorge Juan 78
Madrid
28009
Spain

Sponsor type

Research organisation

Website

http://www.fremap.es/

Funders

Funder type

Hospital/treatment centre

Funder name

Foundation for Biomedical Investigation (Fundación para la Investigación Biomédica, Hospital Clinico San Carlos) (Spain)

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

Publication citations

Additional files

Editorial Notes