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Completed

NCT Number: NCT04817605

Effects of Therapeutic Exercise in Patients With Fibromyalgia

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.

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Key information

Conditions

Therapeutic Exercise Chronic Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Sandra Jiménez 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

Therapeutic exercise

Other

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.

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Universidad de Zaragoza

Other

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 26, 2021
Registry last updated
May 18, 2023

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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