Fibromyalgia
Conditions
Keywords
fibromyalgia, therapeutic exercise, physiotherapy
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.
Interventions
OTHERPE+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.
OTHERET
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Sponsors
University of Valladolid
Universidad de Zaragoza
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Intensity: VAS | Baseline | The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline |
| Fibromyalgia Impact Questionnaire | Baseline | The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Functional Capacity | Baseline | The investigators measure the functional capacity with Senior Fitness Test at baseline |
| body strength | baseline | The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline |
| Pressure pain threshold | baseline | 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 |
| Fatigue | Baseline | The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline |
| kinesiophobia | baseline | The investigators measure the kinesiophobia with TAMPA questionnaire at baseline |
| Quality of life: HAQ | baseline | The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline |
| Central sensitization | baseline | The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline |
| Anxiety and Depression | Baseline | The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline |
| Quality of Sleep | Baseline | The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline |
Countries
Spain
Outcome results
None listed