Pain Education and Therapeutic Exercise for Fibromyalgia

Fibromyalgia Clinical Trial

Official title:

Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03641495
• Other study ID #: University of Valladolid
• Status: Completed
• Phase: N/A
• Start date: September 3, 2018
• Est. completion date: January 30, 2019

Study information

• Verified date: March 2021
• Source: Universidad de Zaragoza
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 30, 2019
• Est. primary completion date: January 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes

Intervention

Other:
• PE+ET
To explain the physiology of nervous system and the mechanism and modulation of acute and chronic pain. To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
• ET
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Locations

Country	Name	City	State
Spain	Sandra Jiménez del Barrio	Soria

Sponsors (2)

Lead Sponsor	Collaborator
Universidad de Zaragoza	University of Valladolid

Country where clinical trial is conducted

Spain, 

Outcome

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