Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

Study Overview
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Brief Summary
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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.

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Other: Experimental: Exercise and Patient-centred education
* Other: Active Comparator: Exercise


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Parallel assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise and Patient-centred education<br> | Other: Experimental: Exercise and Patient-centred education<br>* 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<br>|
| Active Comparator: Exercise<br> | Other: Active Comparator: Exercise<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain intensity | Measured using the Numeric Pain Rating Scale, NPS, 0-10 | Baseline | 
| Pain intensity | Measured using the Numeric Pain Rating Scale, NPS, 0-10 | 4 weeks | 
| Pain intensity | Measured using the Numeric Pain Rating Scale, NPS, 0-10 | 8 weeks | 
| Pain intensity | Measured using the Numeric Pain Rating Scale, NPS, 0-10 | Follow-up 3 months | 
| Disability and Impact of Fibromyalgia | Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100 | Baseline | 
| Disability and Impact of Fibromyalgia | Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100 | 4 weeks | 
| Disability and Impact of Fibromyalgia | Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100 | 8 weeks | 
| Disability and Impact of Fibromyalgia | Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100 | Follow-up 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuropathic components in pain | Measured using the painDETECT Questionnaire | Baseline | 
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | Baseline | 
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | 4 weeks | 
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | 8 weeks | 
| Health-related Quality of Life | Measured using the EuroQol 5D 3L, EQ 5D-3L | Follow-up 3 months | 
| Patients' perception of improvement or decline in clinical status | Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7 | 4 weeks | 
| Patients' perception of improvement or decline in clinical status | Measured using the Patient Global Impression of Change Scale, PGIC, 1-7 | 8 weeks | 
| Patients' perception of improvement or decline in clinical status | Measured using the Patient Global Impression of Change Scale, PGIC, 1-7 | Follow-up 3 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Fibromyalgia, Exercise, Patient-centred Education, Randomised Controlled Trial