Effectiveness of Exercise and Patient-centred Education on Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04220567
• Other study ID #: IPSetubalESS_SHARE
• Status: Recruiting
• Phase: N/A
• Start date: January 7, 2020
• Est. completion date: October 2020

Study information

• Verified date: March 2020
• Source: Instituto Politécnico de Setúbal. Escola Superior de Saúde.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2020
• Est. primary completion date: October 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

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
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).

Locations

Country	Name	City	State
Portugal	Carmen Caeiro	Setúbal

Sponsors (5)

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

Country where clinical trial is conducted

Portugal, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Measured using the Numeric Pain Rating Scale, NPS, 0-10	Baseline
Primary	Pain intensity	Measured using the Numeric Pain Rating Scale, NPS, 0-10	4 weeks
Primary	Pain intensity	Measured using the Numeric Pain Rating Scale, NPS, 0-10	8 weeks
Primary	Pain intensity	Measured using the Numeric Pain Rating Scale, NPS, 0-10	Follow-up 3 months
Primary	Disability and Impact of Fibromyalgia	Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100	Baseline
Primary	Disability and Impact of Fibromyalgia	Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100	4 weeks
Primary	Disability and Impact of Fibromyalgia	Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100	8 weeks
Primary	Disability and Impact of Fibromyalgia	Measured using the Revised Fibromyalgia Impact Questionnaire, FIQr, 0-100	Follow-up 3 months
Secondary	Neuropathic components in pain	Measured using the painDETECT Questionnaire	Baseline
Secondary	Health-related Quality of Life	Measured using the EuroQol 5D 3L, EQ 5D-3L	Baseline
Secondary	Health-related Quality of Life	Measured using the EuroQol 5D 3L, EQ 5D-3L	4 weeks
Secondary	Health-related Quality of Life	Measured using the EuroQol 5D 3L, EQ 5D-3L	8 weeks
Secondary	Health-related Quality of Life	Measured using the EuroQol 5D 3L, EQ 5D-3L	Follow-up 3 months
Secondary	Patients` perception of improvement or decline in clinical status	Measured using the The Patient Global Impression of Change Scale, PGIC, 1-7	4 weeks
Secondary	Patients` perception of improvement or decline in clinical status	Measured using the Patient Global Impression of Change Scale, PGIC, 1-7	8 weeks
Secondary	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