Condition category
Musculoskeletal Diseases
Date applied
12/09/2003
Date assigned
12/09/2003
Last edited
12/05/2009
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 A Hammond

ORCID ID

Contact details

Southern Derbyshire Acute Hosptials NHS Trust
Department of Rheumatology
Derbyshire Royal Infirmary
London Road
Derby
DE1 2QY
United Kingdom
+44 (0)1332 347141 Ext 2418

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0077117143

Study information

Scientific title

Acronym

Study hypothesis

Null hypothesis: there is no significant difference in health status between people with fibromyalgia attending a relaxation programme and self management programme incorporating psycho-educational approaches.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Condition

Musculoskeletal Diseases: Fibromyalgia

Intervention

91 patients with fibromyalgia will be recruited over a 1 year period and randomly allocated to attend either a self-management programme or a relaxation programme. The self-management programme uses educational and behavioural strategies to increase use of self management methods. Both consist of 10 meetings. Outcomes will be evaluated using a self-report questionnaire mailed out before and at 4 and 10 months after intervention.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Measures of adherence with self-management strategies, functional, psychological and health status as well as demographic and health care utilisation information.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2002

Overall trial end date

31/05/2005

Reason abandoned

Eligibility

Participant inclusion criteria

People with fibromyalgia (diagnosed by Consultant Physician) attending the Rheumatology Department, aged over 18 years, able to read English.

Participant type

Patient

Age group

Adult

Gender

Not Specified

Target number of participants

91

Participant exclusion criteria

People with severe disease/functional/psychological problems will be excluded.

Recruitment start date

01/09/2002

Recruitment end date

31/05/2005

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Southern Derbyshire Acute Hosptials NHS Trust
Derby
DE1 2QY
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Southern Derbyshire Acute Hospitals NHS Trust (UK)

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/17008336

Publication citations

  1. Results

    Hammond A, Freeman K, Community patient education and exercise for people with fibromyalgia: a parallel group randomized controlled trial., Clin Rehabil, 2006, 20, 10, 835-846, doi: 10.1177/0269215506072173.

Additional files

Editorial Notes