Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

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

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 Overview

• Status: Unknown
• Conditions: Fibromyalgia
• Intervention / Treatment: Other: Experimental: Exercise and Patient-centred education; Other: Active Comparator: Exercise

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Portugal
  • Setúbal, Portugal, 2914-503
    • Recruiting
    • Carmen Caeiro
    • Contact: Carmen Caeiro, PhD; Phone Number: 5382 00351 265 709 382; Email: carmen.caeiro@ess.ips.pt
    • Contact: Patrícia Falcão, BSc Hons; Phone Number: 5382 00351 265 709 382; Email: patricia.falcao@ess.ips.pt

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Exercise and Patient-centred education	Other: Experimental: Exercise and Patient-centred education; 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: Exercise	Other: Active Comparator: Exercise; 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).

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Instituto Politécnico de Setúbal. Escola Superior de Saúde.
• Collaborators: Centro Hospitalar Lisboa Ocidental; Universidade de Lisboa - Faculdade Letras; Centro Hospitalar de Setúbal E.P.E.; Myos - Associação Nacional Contra a Fibromialgia e Síndrome de Fadiga Crónica

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 7, 2020
• Primary Completion (ANTICIPATED): October 1, 2020
• Study Completion (ANTICIPATED): October 1, 2020

Study Registration Dates

• First Submitted: January 5, 2020
• First Submitted That Met QC Criteria: January 6, 2020
• First Posted (ACTUAL): January 7, 2020

Study Record Updates

• Last Update Posted (ACTUAL): March 10, 2020
• Last Update Submitted That Met QC Criteria: March 6, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Exercise; Fibromyalgia; Randomised Controlled Trial; Patient-centred Education
• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: IPSetubalESS_SHARE

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No