Pain Education and Therapeutic Exercise for Fibromyalgia

Not Applicable

Completed

• Conditions: Fibromyalgia
• Interventions: Other: PE+ET; Other: ET

• Registration Number: NCT03641495
• Lead Sponsor: Universidad de Zaragoza

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2018-08-16
• Study First Submitted QC: 2018-08-21
• Study First Posted: 2018-08-22
• Study Start: 2018-09-03
• Primary Completion: 2019-01-30
• Study Completion: 2019-01-30
• Status Verified: 2021-03
• Last Update Submitted: 2021-03-23
• Last Update Posted: 2021-03-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Pain education plus exercise therapy (PE + ET)	PE+ET	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.
Exercise therapy (ET)	ET	Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.

Primary Outcome Measures

Name	Time	Method
Pain Intensity: VAS	through study completion, an average 10 weeks	The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
Fibromyalgia Impact Questionnaire	through study completion, an average 10 weeks	The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention

Secondary Outcome Measures

Name	Time	Method
Functional Capacity	through study completion, an average 10 weeks	The investigators measure the functional capacity with Senior Fitness Test at the end of treatment
body strength	through study completion, an average 10 weeks	The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment
Central sensitization	through study completion, an average 10 weeks	The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment
Fatigue	through study completion, an average 10 weeks	The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention
Quality of Sleep	Baseline	The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Quality of Sleep: Pittsburg Sleeping Questionnaire	through study completion, an average 10 weeks	The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention
Quality of life: HAQ	through study completion, an average 10 weeks	The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment
Pressure pain threshold	through study completion, an average 10 weeks	The investigators measure the pressure pain threshold of the 18 points described initially by the American College of rheumatology with a digital algometer at the end of treatment
Anxiety and Depression	through study completion, an average 10 weeks	The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention
kinesiophobia	through study completion, an average 10 weeks	The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment

Trial Locations

Locations (1)

Sandra Jiménez del Barrio; 🇪🇸 Soria, Spain