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Pain Education and Therapeutic Exercise for Fibromyalgia

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ClinicalTrials.gov Identifier: NCT03641495
Recruitment Status : Not yet recruiting
First Posted : August 22, 2018
Last Update Posted : August 22, 2018
Sponsor:
Collaborator:
University of Valladolid
Information provided by (Responsible Party):
Sandra Jiménez, 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.


Condition or disease Intervention/treatment Phase
Fibromyalgia Other: PE+ET Other: ET Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia
Estimated Study Start Date : September 3, 2018
Estimated Primary Completion Date : January 30, 2019
Estimated Study Completion Date : August 30, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pain education plus exercise therapy (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.

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.


Active Comparator: Exercise therapy (ET)
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
Other: ET
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.




Primary Outcome Measures :
  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 Outcome Measures :
  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

  19. Analysis of tryptophan metabolites [ Time Frame: baseline ]
    The investigators measure the tryptophan metabolites with blood test analysis at baseline

  20. Analysis of tryptophan metabolites [ Time Frame: through study completion, an average 10 weeks ]
    The investigators measure the tryptophan metabolites with blood test analysis at baseline



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Diagnosed medically with Fibromyalgia
  • Diagnosed according to the American College of Rheumatology criteria

Exclusion Criteria:

  • Any kind of contraindications for physical activity
  • Body Mass Index > 30
  • Previous surgery last year
  • Medication modifications in the last 6 weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03641495


Locations
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Spain
Sandra Jiménez del Barrio Not yet recruiting
Soria, Spain, 42004
Contact: Sandra Jimenez, PhD    677231049    jimenezsandra89@gmail.com   
Sub-Investigator: Luis Ceballos, MsC         
Sponsors and Collaborators
Universidad de Zaragoza
University of Valladolid

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Responsible Party: Sandra Jiménez, Principal Investigator, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT03641495     History of Changes
Other Study ID Numbers: University of Valladolid
First Posted: August 22, 2018    Key Record Dates
Last Update Posted: August 22, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The patient data were confidential and were assigned a number to each patient to maintain confidentiality

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Sandra Jiménez, Universidad de Zaragoza:
fibromyalgia
therapeutic exercise
physiotherapy

Additional relevant MeSH terms:
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Fibromyalgia
Myofascial Pain Syndromes
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases