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

Manuel Rebollo Salas

Status: Completed

Conditions: Fibromyalgia

Treatments: Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING; Procedure: USUAL CARE

Study type: Interventional

Funder types: Other

Identifiers

NCT04855851

USeville-AJRD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: Female

Ages: 20 to 65 years old

Volunteers: Accepts 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

Experimental group

Description:

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

Treatment:

Procedure: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

USUAL CARE

Active Comparator group

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

Treatment:

Procedure: USUAL CARE