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Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia (PNE-ST-FM)

Primary Purpose

Fibromyalgia

Status
Recruiting
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
USUAL CARE
Sponsored by
Manuel Rebollo Salas
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Fibromyalgia, Education, Strength training

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  • Women diagnosed with fibromyalgia.
  • Duration of pain greater than one year.
  • Generalized or present pain in more than two body regions.
  • Not having participated in pain neuroscience education program.
  • Not having participated in physical exercise programs in the last three months.

Exclusion Criteria:

  • Presence of other diseases not related to the musculoskeletal system.
  • Being under medical treatment not related to pain.
  • being under physiotherapeutic treatment related to pain.
  • Unavailability to carry out a physical exercise program.
  • Pregnant or puerperium women.
  • Inability to perform or complete the necessary tests to measure the study variables.

Sites / Locations

  • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de SevillaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

USUAL CARE

Arm Description

Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE) sessions and 12 weeks (3 times/week) of STRENGTH TRAINING (ST)

The subjects of this group will receive Usual Care. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients, and recommendation of aerobic and flexibility exercise

Outcomes

Primary Outcome Measures

Change from Self-report Pain Intensity
Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity
Change from Central Sensitization symptoms
Measured by the Central Sensitization Inventory (CSI). The total CSI score is between 0-100 points. Scores equal to or greater than 40 points are considered positive for Central Sensitization.
Change from Disability
Measured by the Fibromyalgia Impact Questionnaire (FIQ). The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state.

Secondary Outcome Measures

Change from viscoelastic properties.
Measured by the Myoton®.
Change from Autonomic Disfunction symptoms
Measured by the Heart Rate Variability.
Change from Nerve Conduction Velocity
Measured by the Sensory Nerve Action Potential (SNAP).
Change from grip strength
Measure by the dynamometer.
Change from the pressure pain threshold
Measure by the pressure algometer.

Full Information

First Posted
April 16, 2021
Last Updated
May 16, 2022
Sponsor
Manuel Rebollo Salas
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1. Study Identification

Unique Protocol Identification Number
NCT04855851
Brief Title
Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia
Acronym
PNE-ST-FM
Official Title
Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Recruiting
Study Start Date
March 1, 2022 (Actual)
Primary Completion Date
December 30, 2022 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Manuel Rebollo Salas

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
The main goal of this study is to get to know if applying both, pain neuroscience education (PNE) plus strength training (ST) will reduce the pain of fibromyalgia (FM). Both therapies have shown evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their efficacy in combination.
Detailed Description
At present, the increase in knowledge about the neuroscience of pain has led to the integration of psychological factors, such as cognitions and beliefs about pain, fear-avoidance behaviors or catastrophism within the integrative perception of the concept . This has led to the development of therapeutic strategies aimed at the reconceptualization of pain through a treatment method called Pain Neuroscience Education (PNE), having shown evidence in the treatment of pain, disability, catastrophism and physical performance. But despite current advances in pain neuroscience, there are still pain syndromes, such as fibromyalgia, that are the subject of debate and controversy. Fibromyalgia is a syndrome that causes generalized musculoskeletal pain, fatigue, sleep disorders, and physical disability. It is the main cause of chronic generalized musculoskeletal pain, with a prevalence of 1-5% of the world population. Scientific research has provided new insight for the diagnosis of fibromyalgia patients, who are characterized by a central sensitization process. Objectives: To assess the effectiveness of Pain Neuroscience Education and Strength Training to decrease pain and disability; and increasing quality of life and functionality in patients with Fibromyalgia.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Fibromyalgia, Education, Strength training

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
Arm Type
Experimental
Arm Description
Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE) sessions and 12 weeks (3 times/week) of STRENGTH TRAINING (ST)
Arm Title
USUAL CARE
Arm Type
Active Comparator
Arm Description
The subjects of this group will receive Usual Care. In Spain, the treatment provided is mainly pharmacological, adjusted to the symptomatic profile of theses patients, and recommendation of aerobic and flexibility exercise
Intervention Type
Procedure
Intervention Name(s)
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
Intervention Description
The subjects of this group will receive an amount of six sessions that will be applied within 12 weeks. Every 15 days, the subjects will come for a consultation to receive a PNE session and review of the exercise program, which will be carried out 3 times a week for 12 weeks.
Intervention Type
Procedure
Intervention Name(s)
USUAL CARE
Intervention Description
Aerobic exercises will consist of a standard table of low intensity stretching exercises, commonly prescribed to fibromyalgia patients. There will be three series of 30 seconds of each stretch, having a total duration of approximately 40 minutes. Each session will be held twice a week, following the recommendations of the "American College of Sport Medicine". Monitoring will be performed every 15 days by a physiotherapist.
Primary Outcome Measure Information:
Title
Change from Self-report Pain Intensity
Description
Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity
Time Frame
at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week).
Title
Change from Central Sensitization symptoms
Description
Measured by the Central Sensitization Inventory (CSI). The total CSI score is between 0-100 points. Scores equal to or greater than 40 points are considered positive for Central Sensitization.
Time Frame
at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week)
Title
Change from Disability
Description
Measured by the Fibromyalgia Impact Questionnaire (FIQ). The total FIQ score is between 0-100. Thus, 0 represents the highest functional capacity and quality of life and 100 the worst state.
Time Frame
at the start of the study (at baseline, 0 week), after the last treatment session (12th week), 1 month from the last session (16th week), 3 months from the last session (20th week) and 6 months from the last session (32th week)
Secondary Outcome Measure Information:
Title
Change from viscoelastic properties.
Description
Measured by the Myoton®.
Time Frame
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Title
Change from Autonomic Disfunction symptoms
Description
Measured by the Heart Rate Variability.
Time Frame
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Title
Change from Nerve Conduction Velocity
Description
Measured by the Sensory Nerve Action Potential (SNAP).
Time Frame
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Title
Change from grip strength
Description
Measure by the dynamometer.
Time Frame
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Title
Change from the pressure pain threshold
Description
Measure by the pressure algometer.
Time Frame
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Women diagnosed with fibromyalgia. Duration of pain greater than one year. Generalized or present pain in more than two body regions. Not having participated in pain neuroscience education program. Not having participated in physical exercise programs in the last three months. Exclusion Criteria: Presence of other diseases not related to the musculoskeletal system. Being under medical treatment not related to pain. being under physiotherapeutic treatment related to pain. Unavailability to carry out a physical exercise program. Pregnant or puerperium women. Inability to perform or complete the necessary tests to measure the study variables.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Álvaro-José Rodríguez-Domínguez, PT, MSc
Phone
+34629301910
Email
ajrodom@gmail.com
Facility Information:
Facility Name
Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Álvaro-José Rodríguez-Domínguez, PT, MSc
Phone
+34629301910
Email
ajrodom@gmail.com
First Name & Middle Initial & Last Name & Degree
Álvaro-José Rodríguez-Domínguez, PT, MSc
First Name & Middle Initial & Last Name & Degree
Manuel Rebollo-Salas, PT, PhD
First Name & Middle Initial & Last Name & Degree
José-Jesús Jiménez-Rejano, PT, PhD
First Name & Middle Initial & Last Name & Degree
Raquel Chillón-Martínez, PT, PhD
First Name & Middle Initial & Last Name & Degree
Mercedes Álvarez-López, MD

12. IPD Sharing Statement

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Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

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