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Completed

NCT Number: NCT03641495

Pain Education and Therapeutic Exercise for Fibromyalgia

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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sandra Jiménez del Barrio

Soria, 42004, Spain

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

PE+ET

Other

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

Other

To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.

Primary outcomes

  1. Pain Intensity: VAS

    Time frame: Baseline

    The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline

  2. Pain Intensity: VAS

    Time frame: 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

  3. Fibromyalgia Impact Questionnaire

    Time frame: Baseline

    The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline

  4. Fibromyalgia Impact Questionnaire

    Time frame: 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 outcomes

  1. Fatigue

    Time frame: Baseline

    The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline

  2. Fatigue

    Time frame: through study completion, an average 10 weeks

    The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention

  3. Quality of Sleep

    Time frame: Baseline

    The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline

  4. Quality of Sleep: Pittsburg Sleeping Questionnaire

    Time frame: 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

  5. Functional Capacity

    Time frame: Baseline

    The investigators measure the functional capacity with Senior Fitness Test at baseline

  6. Functional Capacity

    Time frame: through study completion, an average 10 weeks

    The investigators measure the functional capacity with Senior Fitness Test at the end of treatment

  7. body strength

    Time frame: baseline

    The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline

  8. body strength

    Time frame: 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

  9. Pressure pain threshold

    Time frame: 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

  10. Pressure pain threshold

    Time frame: 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

  11. Anxiety and Depression

    Time frame: Baseline

    The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline

  12. Anxiety and Depression

    Time frame: 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

  13. kinesiophobia

    Time frame: baseline

    The investigators measure the kinesiophobia with TAMPA questionnaire at baseline

  14. kinesiophobia

    Time frame: through study completion, an average 10 weeks

    The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment

  15. Quality of life: HAQ

    Time frame: baseline

    The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline

  16. Quality of life: HAQ

    Time frame: through study completion, an average 10 weeks

    The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment

  17. Central sensitization

    Time frame: baseline

    The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline

  18. Central sensitization

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Collaborators

  • University of Valladolid

Registry information

Official study title

Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia

Important dates

Study start
2018
Primary completion
2019
Study completion
2019
First posted
Aug 22, 2018
Registry last updated
Mar 26, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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