Is a Combined Programme of Exercise and Patient-centred Education More Effective Than Exercise Alone in Individuals With Fibromyalgia? A Randomised Controlled Trial

Instituto Politécnico de Setúbal. Escola Superior de Saúde.1 site in 1 country60 target enrollmentJanuary 7, 2020

ConditionsFibromyalgia

Overview

Phase: N/A
Intervention: Not specified
Conditions: Fibromyalgia
Sponsor: Instituto Politécnico de Setúbal. Escola Superior de Saúde.
Enrollment: 60
Locations: 1
Primary Endpoint: Pain intensity
Last Updated: 6 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

This study aims to compare the effects of an eight-week exercise and patient-centred education programme with eight-week exercise alone programme on disability, pain intensity, health-related quality of life and patient global impression of change.

A prospective, parallel, double-blinded and multi-centre randomised controlled trial will be carried out.

Registry

clinicaltrials.gov

Start Date

January 7, 2020

End Date

October 2020

Last Updated

6 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Instituto Politécnico de Setúbal. Escola Superior de Saúde.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Diagnosis of fibromyalgia according to the American College of Rheumatology criteria (2016)

Exclusion Criteria

•Presence of uncontrolled medical disorders (cardiovascular/ metabolic/ neurological/ renal)
•Presence of active oncological disease (or until 5 years and undergoing treatment)
•Presence of inflammatory rheumatic diseases other than fibromyalgia
•Presence of inflammatory osteoarticular disease or severe osteoarthritis (grade IV de Kellgren - Lawrence Classification of Osteoarthritis)
•Previous orthopaedic (column or lower limb) or cardiothoracic surgery in the year before;
•Disability not compatible with the exercise practice required
•Pregnancy
•Attendance to a physiotherapy programme including exercise in the previous three months
•Difficulty in written communication that prevent the fulfilment of self-reported questionnaires.

Outcomes

Primary Outcomes

Pain intensity

Time Frame: Follow-up 3 months

Measured using the Numeric Pain Rating Scale, NPS, 0-10

Disability and Impact of Fibromyalgia

Time Frame: Follow-up 3 months

Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

Secondary Outcomes

Neuropathic components in pain(Baseline)
Patients' perception of improvement or decline in clinical status(Follow-up 3 months)
Health-related Quality of Life(Follow-up 3 months)