Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

Not Applicable

Active, not recruiting

• Conditions: Fibromyalgia
• Interventions: Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING; Procedure: USUAL CARE

• Registration Number: NCT04855851
• Lead Sponsor: Manuel Rebollo Salas

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.

Study Timeline

• Study First Submitted: 2021-04-16
• Study First Submitted QC: 2021-04-21
• Study First Posted: 2021-04-22
• Study Start: 2022-03-01
• Primary Completion: 2023-12-30
• Status Verified: 2024-04
• Last Update Submitted: 2024-04-07
• Last Update Posted: 2024-04-09
• Study Completion: 2025-06-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING	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)
USUAL CARE	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

Primary Outcome Measures

Name	Time	Method
Change from Disability	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.
Change from Self-report 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).	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	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.

Secondary Outcome Measures

Name	Time	Method
Change from the pressure pain threshold	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.
Change from viscoelastic properties.	at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]	Measured by the Myoton®.
Change from grip strength	at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]	Measure by the dynamometer.
Change from Nerve Conduction Velocity	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).
Change from Autonomic Disfunction symptoms	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.

Trial Locations

Locations (1)

Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla; 🇪🇸 Sevilla, Spain