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Completed

NCT Number: NCT04855851

Effectiveness of Pain Neuroscience Education and Strength Training in 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.

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Key information

Conditions

Fibromyalgia Muscular Diseases Musculoskeletal Diseases Nervous System Diseases Neuromuscular Diseases Rheumatic Diseases

Age range

20 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla

Seville, Spain, 41009

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

Procedure

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.

usual care

Procedure

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 outcomes

  1. 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

  2. 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.

  3. 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.

Secondary outcomes

  1. 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®.

  2. 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.

  3. 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).

  4. 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.

  5. 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.

Sponsors and collaborators

Lead sponsor

Manuel Rebollo Salas

Other

Registry information

Official study title

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

Acronym: PNE-ST-FM

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Apr 22, 2021
Registry last updated
Aug 26, 2025

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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