Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

Not Applicable

• Conditions: Fibromyalgia

• Registration Number: NCT04220567
• Lead Sponsor: Instituto Politécnico de Setúbal. Escola Superior de Saúde.

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-01-05
• Study First Submitted QC: 2020-01-06
• Study Start: 2020-01-07
• Study First Posted: 2020-01-07
• Status Verified: 2020-03
• Last Update Submitted: 2020-03-06
• Last Update Posted: 2020-03-10
• Primary Completion: 2020-10
• Study Completion: 2020-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Pain intensity	Follow-up 3 months	Measured using the Numeric Pain Rating Scale, NPS, 0-10
Disability and Impact of Fibromyalgia	Follow-up 3 months	Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100

Secondary Outcome Measures

Name	Time	Method
Neuropathic components in pain	Baseline	Measured using the painDETECT Questionnaire
Patients' perception of improvement or decline in clinical status	Follow-up 3 months	Measured using the Patient Global Impression of Change Scale, PGIC, 1-7
Health-related Quality of Life	Follow-up 3 months	Measured using the EuroQol 5D 3L, EQ 5D-3L

Trial Locations

Locations (1)

Carmen Caeiro; 🇵🇹 Setúbal, Portugal