Effectiveness of Pain Neuroscience Education and Strength Training in Fibromyalgia

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

Sponsors

Lead Sponsor: Manuel Rebollo Salas

Source University of Seville
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.

Overall Status Not yet recruiting
Start Date 2021-07-01
Completion Date 2022-06-30
Primary Completion Date 2021-11-30
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
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).
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)
Change from Quality of Life 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
Measure Time Frame
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)
Change from Autonomic Disfunction 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)
Change from Nerve Conduction Velocity 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)
Enrollment 60
Condition
Intervention

Intervention Type: Procedure

Intervention Name: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

Description: 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.

Arm Group Label: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

Intervention Type: Procedure

Intervention Name: USUAL CARE

Description: 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.

Arm Group Label: USUAL CARE

Eligibility

Criteria:

Inclusion Criteria: - Women diagnosed with fibromyalgia. - Duration of pain greater than one year. - Generalized or present paijn 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.

Gender:

Female

Minimum Age:

20 Years

Maximum Age:

65 Years

Healthy Volunteers:

Accepts Healthy Volunteers

Overall Contact

Last Name: Álvaro-José Rodríguez-Domínguez, PT, MSc

Phone: +34629301910

Email: [email protected]

Location
Facility: Contact: Investigator: Grupo de Investigación Área de Fisioterapia CTS 305 - Universidad de Sevilla Álvaro-José Rodríguez-Domínguez, PT, MSc +34629301910 [email protected] Álvaro-José Rodríguez-Domínguez, PT, MSc Principal 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 Sub-Investigator
Location Countries

Spain

Verification Date

2021-04-01

Responsible Party

Type: Sponsor-Investigator

Investigator Affiliation: University of Seville

Investigator Full Name: Manuel Rebollo Salas

Investigator Title: Director

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Label: PAIN NEUROSCIENCE EDUCATION AND STRENGTH TRAINING

Type: Experimental

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

Label: USUAL CARE

Type: Active Comparator

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

Acronym PNE-ST-FM
Study Design Info

Allocation: Randomized

Intervention Model: Parallel Assignment

Primary Purpose: Treatment

Masking: Single (Outcomes Assessor)

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