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Effects of Therapeutic Exercise in Patients With Fibromyalgia

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ClinicalTrials.gov Identifier: NCT04817605
Recruitment Status : Recruiting
First Posted : March 26, 2021
Last Update Posted : March 26, 2021
Sponsor:
Information provided by (Responsible Party):
Sandra Jiménez, Universidad de Zaragoza

Study Description
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Brief Summary:

Fibromyalgia syndrome is characterized by chronic generalized musculoskeletal pain associated with fatigue, sleep disturbances and some biochemical markers. 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 therapeutic exercise is effective on fatigue, pain threshold, quality of life, quality of sleep, pain coping and biochemical and genetic markers.

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 one group receiving exercise therapy consisting of 3 treatment sessions a week over 10 weeks.

The variables are measured at the beginning and end of treatment.


Condition or disease Intervention/treatment Phase
Therapeutic Exercise Chronic Pain Other: Therapeutic Exercise Early Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Effects of Therapeutic Exercise in Patients With Fibromyalgia
Actual Study Start Date : March 10, 2021
Estimated Primary Completion Date : June 10, 2021
Estimated Study Completion Date : June 20, 2021

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Exercise Therapy Other: Therapeutic Exercise
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.


Outcome Measures
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Primary Outcome Measures :
  1. Pain intensity [ Time Frame: Baseline ]
    VAS

  2. Pain intensity [ Time Frame: through study completion, an average 10 weeks ]
    VAS

  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 [ Time Frame: through study completion, an average 10 weeks ]
    The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Central sensitization [ Time Frame: Baseline ]
    The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline

  4. Central sensitization [ Time Frame: through study completion, an average 10 weeks ]
    The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS)

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

  6. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT04817605


Locations
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Spain
Sandra Jiménez Jiménez-del-Barrio Recruiting
Soria, Spain, 42004
Contact: Sandra J Jiménez-del-Barrio, PhD    677231049    sandra.jimenez.barrio@uva.es   
Contact: Luis C Ceballos-Laita, PhD    677380938    luis.ceballos@uva.es   
Sponsors and Collaborators
Universidad de Zaragoza
More Information
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Responsible Party: Sandra Jiménez, University of Valladolid Faculty of Health Sciences, Universidad de Zaragoza
ClinicalTrials.gov Identifier: NCT04817605    
Other Study ID Numbers: UVa
First Posted: March 26, 2021    Key Record Dates
Last Update Posted: March 26, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Fibromyalgia
Chronic Pain
Pain
Neurologic Manifestations
Muscular Diseases
 Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases