Condition category
Musculoskeletal Diseases
Date applied
17/02/2006
Date assigned
20/02/2006
Last edited
28/10/2008
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 Kati Thieme

ORCID ID

Contact details

1959 NE Pacific Street
Box 356540
Seattle
Washington
98195-6540
United States of America
+1 206 685 2082
thiemek@u.washington.edu

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

Th 899/2-1, Th 899/2-2

Study information

Scientific title

Acronym

CBTOBTFMS

Study hypothesis

1. Cognitive-Behavioral Therapy (CBT) and Operant-Behavioral Therapy (OBT) will produce significant improvements in pain, physical functioning, and emotional distress in Fibromyalgia Syndrome (FMS) patients
2. CBT and OBT will produce significantly greater improvements in pain, physical functioning, and emotional distress than the Attention Placebo (AP) treatment
3. CBT will produce significantly greater effects than the OBT and AP groups on coping and catastrophizing responses. Since the OBT indirectly focuses on inappropriate beliefs, it will produce significantly greater improvements on coping and catastrophizing than the AP group.
4. OBT will produce significantly greater reductions in pain, behaviors, physical therapy, and medication than CBT or AP treatments. Since CBT indirectly focuses on maladaptive behaviors, it will produce significantly greater improvements in pain behaviors than the AP group.

Ethics approval

Approved by Charite, Humboldt-University, Berlin, Germany on 01/02/2000, reference number 1270/2000

Study design

Randomized, placebo-controlled clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Fibromyalgia syndrome

Intervention

The operant- and cognitive-behavioral pain therapy were compared to an attention placebo group (a social discussion group), a physiotherapy and a wait-list control group

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Pain
2. Physical impairment
3. Affective distress

Secondary outcome measures

1. Coping
2. Catastrophizing
3. Pain behaviour
4. Number of physician visits
5. Spouse behavior

Overall trial start date

01/04/2000

Overall trial end date

01/04/2005

Reason abandoned

Eligibility

Participant inclusion criteria

1. Participants must suffer from FMS as validated by a rheumatologist
2. They must meet the American College of Rheumatology (ACR) criteria for FMS
3. Pain for a period of at least six months
4. Married, and must show willingness of the spouse to be involved
5. Ability to complete the questionnaires and understand the treatment components

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

180

Participant exclusion criteria

1. Inflammatory rheumatic diseases
2. Acute episode of carcinoma
3. Psychotic episode
4. Opioid abuse

Recruitment start date

01/04/2000

Recruitment end date

01/04/2005

Locations

Countries of recruitment

Germany

Trial participating centre

1959 NE Pacific Street
Washington
98195-6540
United States of America

Sponsor information

Organisation

German Research Council (Deutsche Forschungsgemeinschaft) (DFG)

Sponsor details

DFG
Kennedyallee 40
Bonn
53170
Germany
+49 (0)22 8885 2626
Anne.Brueggemann@dfg.de

Sponsor type

Research organisation

Website

http://www.dfg.de

Funders

Funder type

Charity

Funder name

German Research Council (Deutsche Forschungsgemeinschaft) (DFG)

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

2006 results in http://www.ncbi.nlm.nih.gov/pubmed/16859516

Publication citations

  1. Results

    Thieme K, Flor H, Turk DC, Psychological pain treatment in fibromyalgia syndrome: efficacy of operant behavioural and cognitive behavioural treatments., Arthritis Res. Ther., 2006, 8, 4, R121, doi: 10.1186/ar2010.

Additional files

Editorial Notes