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Pain Education and Therapeutic Exercise for Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PE+ET
ET
Sponsored by
Universidad de Zaragoza
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring fibromyalgia, therapeutic exercise, physiotherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Sandra Jiménez del Barrio

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Pain education plus exercise therapy (PE + ET)

Exercise therapy (ET)

Arm Description

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.

Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.

Outcomes

Primary Outcome Measures

Pain Intensity: VAS
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline
Pain Intensity: VAS
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
Fibromyalgia Impact Questionnaire
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline
Fibromyalgia Impact Questionnaire
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention

Secondary Outcome Measures

Fatigue
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline
Fatigue
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention
Quality of Sleep
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Quality of Sleep: Pittsburg Sleeping Questionnaire
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention
Functional Capacity
The investigators measure the functional capacity with Senior Fitness Test at baseline
Functional Capacity
The investigators measure the functional capacity with Senior Fitness Test at the end of treatment
body strength
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline
body strength
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment
Pressure pain threshold
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
Pressure pain threshold
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
Anxiety and Depression
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline
Anxiety and Depression
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention
kinesiophobia
The investigators measure the kinesiophobia with TAMPA questionnaire at baseline
kinesiophobia
The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment
Quality of life: HAQ
The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline
Quality of life: HAQ
The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment
Central sensitization
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
Central sensitization
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment

Full Information

First Posted
August 16, 2018
Last Updated
March 23, 2021
Sponsor
Universidad de Zaragoza
Collaborators
University of Valladolid
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1. Study Identification

Unique Protocol Identification Number
NCT03641495
Brief Title
Pain Education and Therapeutic Exercise for Fibromyalgia
Official Title
Effects of Pain Education and Therapeutic Exercise for Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
September 3, 2018 (Actual)
Primary Completion Date
January 30, 2019 (Actual)
Study Completion Date
January 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidad de Zaragoza
Collaborators
University of Valladolid

4. Oversight

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

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
fibromyalgia, therapeutic exercise, physiotherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Pain education plus exercise therapy (PE + ET)
Arm Type
Experimental
Arm Description
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.
Arm Title
Exercise therapy (ET)
Arm Type
Active Comparator
Arm Description
Exercise therapy based primarily in aerobic exercise according clinical guidelines last recommendations.
Intervention Type
Other
Intervention Name(s)
PE+ET
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
ET
Intervention Description
To perform different whole body aerobic exercises with a mild to moderate intensity according to Borg scale and maximum heart rate.
Primary Outcome Measure Information:
Title
Pain Intensity: VAS
Description
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) pre-intervention at baseline
Time Frame
Baseline
Title
Pain Intensity: VAS
Description
The investigators measure the intensity of pain with a Visual Analogic Scale (VAS) at the end of the intervention
Time Frame
through study completion, an average 10 weeks
Title
Fibromyalgia Impact Questionnaire
Description
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) pre-intervention at baseline
Time Frame
Baseline
Title
Fibromyalgia Impact Questionnaire
Description
The investigators measure the impact of Fibromyalgia syndrome by Fibromyalgia Impact Questionnaire R (FIQ-R) at the end of the intervention
Time Frame
through study completion, an average 10 weeks
Secondary Outcome Measure Information:
Title
Fatigue
Description
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) pre-intervention at baseline
Time Frame
Baseline
Title
Fatigue
Description
The investigators measure the fatigue with Multidimensional Fatigue Inventory (MFI-S) at the end of the intervention
Time Frame
through study completion, an average 10 weeks
Title
Quality of Sleep
Description
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at baseline
Time Frame
Baseline
Title
Quality of Sleep: Pittsburg Sleeping Questionnaire
Description
The investigators measure the quality of sleep with Pittsburg Sleeping Questionnaire Index (PSQI) at the end of the intervention
Time Frame
through study completion, an average 10 weeks
Title
Functional Capacity
Description
The investigators measure the functional capacity with Senior Fitness Test at baseline
Time Frame
Baseline
Title
Functional Capacity
Description
The investigators measure the functional capacity with Senior Fitness Test at the end of treatment
Time Frame
through study completion, an average 10 weeks
Title
body strength
Description
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at baseline
Time Frame
baseline
Title
body strength
Description
The investigators measure the strength of arms with handgrip test, elbow flexion and knee extension with handheld dynamometer at the end of treatment
Time Frame
through study completion, an average 10 weeks
Title
Pressure pain threshold
Description
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
Time Frame
baseline
Title
Pressure pain threshold
Description
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
Time Frame
through study completion, an average 10 weeks
Title
Anxiety and Depression
Description
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at baseline
Time Frame
Baseline
Title
Anxiety and Depression
Description
The investigators measure the anxiety and depression with Hospital Anxiety and Depression Scale (HADS) at the end of the intervention
Time Frame
through study completion, an average 10 weeks
Title
kinesiophobia
Description
The investigators measure the kinesiophobia with TAMPA questionnaire at baseline
Time Frame
baseline
Title
kinesiophobia
Description
The investigators measure the kinesiophobia with TAMPA questionnaire at the end of treatment
Time Frame
through study completion, an average 10 weeks
Title
Quality of life: HAQ
Description
The investigators measure the quality of life with Health Assessment Questionnaire (HAQ) at baseline
Time Frame
baseline
Title
Quality of life: HAQ
Description
The investigators measure the quality of life with ( Health Assessment Questionnaire (HAQ) at the end of treatment
Time Frame
through study completion, an average 10 weeks
Title
Central sensitization
Description
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at baseline
Time Frame
baseline
Title
Central sensitization
Description
The investigators measure the central sensitization with Chronic Pain Self-Efficacy Scale (CPSS) at the end of treatment
Time Frame
through study completion, an average 10 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Facility Information:
Facility Name
Sandra Jiménez del Barrio
City
Soria
ZIP/Postal Code
42004
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
The patient data were confidential and were assigned a number to each patient to maintain confidentiality

Learn more about this trial

Pain Education and Therapeutic Exercise for Fibromyalgia

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