Condition category
Musculoskeletal Diseases
Date applied
11/06/2008
Date assigned
29/09/2008
Last edited
02/10/2014
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 Javier Garcia-Campayo

ORCID ID

Contact details

Servicio de Psiquiatría
Hospital Universitario Miguel Servet
Avda Isabel La Católica 1
Zaragoza
50009
Spain
+34 (0)976 25 36 21
jgarcamp@arrakis.es

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

ETES nº PI07/90959

Study information

Scientific title

Acronym

Study hypothesis

Pharmacological and psychological treatments are more effective for the treatment of pain catastrophising in patients with fibromyalgia than usual treatment at primary care level.

Ethics approval

Ethical Review Board of the Regional Health Authority, February 2007, ref: ETES nº PI07/90959

Study design

Multicentre three-arm random allocation controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Fibromyalgia

Intervention

Psychological intervention:
Manualised protocol developed by Prof. Escobar et al, of the University of New Jersey, for the treatment of somatoform disorders that has been adapted by our group for the treatment of fibromyalgia. It includes 10 weekly sessions of cognitive-behaviour therapy.

Pharmacological intervention:
In this group of patients, pregabalin (300 - 450 mg/day), recommended for the treatment of fibromyalgia, associated with duloxetine (60 - 120 mg/day) if there is comorbid depression, will be administered.

Treatment as usual at primary care level:
This group will follow the usual treatment given at primary care level.

Intervention type

Drug

Phase

Not Applicable

Drug names

Pregabalin, duloxetine

Primary outcome measures

The major outcome is pain catastrophising in patients with fibromyalgia. This construct will be assessed with the Spanish version of the Pain Catastrophising Scale. Assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention

Secondary outcome measures

1. The following socio-demographic data will be collected: sex, age, marital status, education, occupation and social class: administered only at baseline
2. The diagnosis of psychiatric disorders will be made with the Structured Polyvalent Psychiatric Interview, a psychiatric interview extensively used for the study of somatoform disorders: administered only at baseline
3. Hamilton test for Anxiety (HAM-A) and for Depression (HAM-D); assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention
4. Fibromyalgia Impact Questionnaire (FIQ): the FIQ is a 10-item self-report questionnaire developed to measure the health status of fibromyalgia patients; assessments will take place at baseline, 3 months, 6 months and 1-year post-intervention

Overall trial start date

01/09/2008

Overall trial end date

31/12/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged 18 - 65 years, either sex
2. Able to understand and read Spanish
3. Fulfil criteria for primary fibromyalgia according to the American College of Rheumatology
4. No previous psychological treatment
5. No pharmacological treatment or acceptance to discontinue it two weeks before the onset of the study
6. Signed informed consent

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180 patients (60 in each of the three groups)

Participant exclusion criteria

1. Severe Axis I psychiatric disorder (dementia, schizophrenia, paranoid disorder, abuse of alcohol and/or drug disorders)
2. Severe Axis II disorder from the clinician viewpoint that prevents the patient from following the treatment protocol
3. Pregnancy or lactation
4. Refusal to participate

Recruitment start date

01/09/2008

Recruitment end date

31/12/2009

Locations

Countries of recruitment

Spain

Trial participating centre

Servicio de Psiquiatría
Zaragoza
50009
Spain

Sponsor information

Organisation

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

Sponsor details

C/ Sinesio Delgado 6
Madrid
28029
Spain
+34 (0)91 82 22 131
oficina.informacion@isciii.es

Sponsor type

Research organisation

Website

http://www.isciii.es

Funders

Funder type

Research organisation

Funder name

The Carlos III Health Institute (Instituto de Salud Carlos III) (Spain) (ref: ETES nº PI07/90959)

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

2009 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/19389246
2014 results in: http://www.ncbi.nlm.nih.gov/pubmed/25270426

Publication citations

  1. Protocol

    García-Campayo J, Serrano-Blanco A, Rodero B, Magallón R, Alda M, Andrés E, Luciano JV, del Hoyo YL, Effectiveness of the psychological and pharmacological treatment of catastrophization in patients with fibromyalgia: a randomized controlled trial., Trials, 2009, 10, 24, doi: 10.1186/1745-6215-10-24.

  2. Results

    Luciano JV, D Amico F, Cerdà-Lafont M, Peñarrubia-María MT, Knapp M, Cuesta-Vargas AI, Serrano-Blanco A, García-Campayo J, Cost-utility of cognitive behavioural therapy versus U.S. food and drug administration recommended drugs and usual care in the treatment of patients with fibromyalgia: an economic evaluation alongside a 6-month randomised controlled trial., Arthritis Res. Ther., 2014, 16, 5, 451, doi: 10.1186/s13075-014-0451-y.

Additional files

Editorial Notes