Condition category
Musculoskeletal Diseases
Date applied
15/12/2008
Date assigned
23/12/2008
Last edited
23/12/2008
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 Susanna Maddali Bongi

ORCID ID

Contact details

Associazione per lo studio della Sclerosi Sistemica e delle Malattie Fibrosanti (ASSMaF)
Viale Pieraccini 18
Firenze
50139
Italy

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Rehabilitation of fibromyalgia: efficacy of the Rességuier method - a randomised controlled trial

Acronym

Study hypothesis

Rehabilitation holds an important role in the treatment of fibromyalgia syndrome (FMS). Despite numerous studies, an agreement on a specific rehabilitation line, adaptable to the needs of a heterogeneous group of patients, has not been found yet. The Rességuier method is a rehabilitation technique never experimented in fibromyalgia.

Ethics approval

Not provided at the time of registration

Study design

Randomised controlled single centre trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Fibromyalgia

Intervention

FMS patients were recruited and randomly assigned to the Group A and Group B. The patients of Group A were individually treated with the Rességuier method for 8 weeks, 1 session a week. The patients of Group B were observed for 8 weeks.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Reduction of pain (Numerical Rating Scale [NRS]: 0 - 10)
2. Improvement of disability and quality of life, assessed by the 36-item Short Form (SF-36) Health Survey and Fibromyalgia Impact Questionnaire (FIQ)

Secondary outcome measures

1. Quality of movement (NRS: 0 - 10)
2. Ability to relax mind and body (NRS: 0 - 10)

Overall trial start date

10/01/2007

Overall trial end date

10/12/2007

Reason abandoned

Eligibility

Participant inclusion criteria

1. Diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) criteria
2. No age limits

Participant type

Patient

Age group

Other

Gender

Both

Target number of participants

36

Participant exclusion criteria

Does not meet the inclusion criteria

Recruitment start date

10/01/2007

Recruitment end date

10/12/2007

Locations

Countries of recruitment

Italy

Trial participating centre

Associazione per lo studio della Sclerosi Sistemica e delle Malattie Fibrosanti (ASSMaF)
Firenze
50139
Italy

Sponsor information

Organisation

University of Florence (Italy)

Sponsor details

Department of Medicine
Viale GB Morgagni 85
Florence
50134
Italy

Sponsor type

University/education

Website

http://www.unifi.it

Funders

Funder type

University/education

Funder name

University of Florence (Italy) - Department of Medicine

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