Clinical trial NCT04855851: Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia
Official title: Effectiveness of Pain Neuroscience Education and Strength Training Program in Patients With Fibromyalgia
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Fibromyalgia
Keywords: Fibromyalgia
Education
Strength training
Lead sponsor: University of Seville
Sponsor class: OTHER
First posted: 2021-04-22
Enrollment: 60
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: Change from Self-report Pain Intensity
timeFrame: 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).
measure: Change from Central Sensitization symptoms
timeFrame: 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)
measure: Change from Disability
timeFrame: 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 outcomes:
measure: Change from viscoelastic properties.
timeFrame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
measure: Change from Autonomic Disfunction symptoms
timeFrame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
measure: Change from Nerve Conduction Velocity
timeFrame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
measure: Change from grip strength
timeFrame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
measure: Change from the pressure pain threshold
timeFrame: at the start of the study (at baseline, 0 week) and after 6 months from the last session (32th week)]
Other outcomes:
Locations:
city: Sevilla
country: Spain
facility: Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla
Study officials:
References:
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