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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03641495
Other study ID # University of Valladolid
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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