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

May 16, 2022 updated by: Manuel Rebollo Salas

Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Álvaro-José Rodríguez-Domínguez, PT, MSc
  • Phone Number: +34629301910
  • Email: ajrodom@gmail.com

Study Locations

  • Spain
      • Sevilla, Spain, 41009
        • Recruiting
        • Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
        • Contact:
          • Álvaro-José Rodríguez-Domínguez, PT, MSc
          • Phone Number: +34629301910
          • Email: ajrodom@gmail.com
        • Principal Investigator:
          • Álvaro-José Rodríguez-Domínguez, PT, MSc
        • Sub-Investigator:
          • Manuel Rebollo-Salas, PT, PhD
        • Sub-Investigator:
          • José-Jesús Jiménez-Rejano, PT, PhD
        • Sub-Investigator:
          • Raquel Chillón-Martínez, PT, PhD
        • Sub-Investigator:
          • Mercedes Álvarez-López, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
Subjects will receive 6 PAIN NEUROSCIENCE EDUCATION (PNE) sessions and 12 weeks (3 times/week) of STRENGTH TRAINING (ST)
Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING
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.
Active Comparator: USUAL CARE
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
Procedure: USUAL CARE
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from Self-report 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).
Evaluated by the visual analogue scale (VAS). The total VAS score is between 0-10 cm. A higher score indicates greater pain intensity
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).
Change from Central Sensitization symptoms
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)
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.
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)
Change from Disability
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)
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.
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 Measures

Outcome Measure
Measure Description
Time Frame
Change from viscoelastic properties.
Time Frame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Measured by the Myoton®.
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Change from Autonomic Disfunction symptoms
Time Frame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Measured by the Heart Rate Variability.
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Change from Nerve Conduction Velocity
Time Frame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Measured by the Sensory Nerve Action Potential (SNAP).
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Change from grip strength
Time Frame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Measure by the dynamometer.
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Change from the pressure pain threshold
Time Frame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Measure by the pressure algometer.
at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Manuel Rebollo Salas

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2022

Primary Completion (Anticipated)

December 30, 2022

Study Completion (Anticipated)

September 30, 2023

Study Registration Dates

First Submitted

April 16, 2021

First Submitted That Met QC Criteria

April 21, 2021

First Posted (Actual)

April 22, 2021

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • USeville-AJRD

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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