Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

N/AUnknownNCT04220567

Instituto Politécnico de Setúbal. Escola Superior de Saúde.60 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Fibromyalgia

Interventions

Experimental: Exercise and Patient-centred educationOTHER

An eight-week programme based on 24 sessions of exercise supervised by a physiotherapist. Exercise will be carried out three times a week. Once a week the exercise session is performed autonomously by patient at home (according to the physiotherapist's recommendations). Patient-centred Education will follow the principles of transformative learning \& incorporate patients' narratives. It will precede 9 of the 24 exercise sessions and be delivered by the same physiotherapist

Active Comparator: ExerciseOTHER

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Carmen Caeiro

Setúbal, Portugal

RECRUITING

Outcomes

Primary Outcomes

Pain intensity

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

Time frame: Baseline

Pain intensity

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

Time frame: 4 weeks

Pain intensity

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

Time frame: 8 weeks

Pain intensity

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

Time frame: Follow-up 3 months

Disability and Impact of Fibromyalgia

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

Time frame: Baseline

Disability and Impact of Fibromyalgia

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

Time frame: 4 weeks

Disability and Impact of Fibromyalgia

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

Time frame: 8 weeks

Disability and Impact of Fibromyalgia

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

Time frame: Follow-up 3 months

Secondary Outcomes

Neuropathic components in pain

Data from ClinicalTrials.gov

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