Pain Education and Therapeutic Exercise for Fibromyalgia

University of Zaragoza

Status: Completed

Conditions: Fibromyalgia

Treatments: Other: ET; Other: PE+ET

Study type: Interventional

Funder types: Other

Identifiers

NCT03641495

University of Valladolid

Details and patient eligibility

About

Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and psychological problems. The European League Againts Rheumatism (EULAR) described an algorithm how to treat step by step these patients.

The objective of this trial is to evaluate if patient education plus therapeutic exercise is more effective in pain intensity, fatigue, function, strength, pain threshold, anxiety, depression, quality of life, quality of sleep, kinesiophobia, pain coping and biochemical and genetic markers and compared to therapeutic exercise.

For this purpose the investigators conduct a randomized controlled trial double-blind (patient and examiner). The investigators included patients diagnosed of fibromyalgia according to the American College of Rheumatology (ACR).

Patients included are randomized into 2 groups one receive education of pain neurophysiology plus exercise therapy and the other only exercise therapy. Groups receive 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment. And also some variables are measured before and after each session.

Enrollment: 32 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Diagnosed medically with Fibromyalgia
• Diagnosed according to the American College of Rheumatology criteria
• Agreement to attend to treatment sessions

Exclusion criteria

• Any kind of contraindications for physical activity
• Other kind of diseases that could limit the intervention
• Previous surgery last year
• Medication modifications in the last 3 months

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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32 participants in 2 patient groups

Pain education plus exercise therapy (PE + ET)

Experimental group

Description:

Pain education according to the book "Explain Pain" written by Lorimer Moseley and David Butler Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.

Treatment:

Other: PE+ET

Exercise therapy (ET)

Active Comparator group

Description:

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.

Treatment:

Other: ET