Clinical trial NCT04539171: Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia
Official title: Effectiveness of a Group Intervention Through Education in Pain Neurophysiology and Exercise in Women With Fibromyalgia: a Quasi-experimental Study in Primary Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Keywords: Central Nervous System Sensitization
Chronic pain
Fibromyalgia
Neuroscience
Patient education
Lead sponsor: Maimónides Biomedical Research Institute of Córdoba
Sponsor class: OTHER
Collaborators: name: Castilla-León Health Service
First posted: 2020-09-04
Enrollment: 53
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Quasi-experimental, controlled, non-randomized study
Primary purpose: TREATMENT

Brief summary: This study evaluates the effects of a pain neuroscience education (PNE) and physical exercise (PE) program in women with fibromyalgia. The intervention group receives PNE and PE program supervised by a physiotherapist and a Family Doctor and the control group standard care, in primary care.

Detailed description: Objectives: To evaluate the effectiveness of a PNE and PE in patients with fibromyalgia (FM).

Design: Quasi-experimental, controlled, non-randomized study, in Primary Care facilities.

Intervention: 6 weekly sessions (2 hours each), and a reminder session one month later.

Main measurements: Compliance with FM criteria, assessed using the Widespread Pain Index (WPI) and the Severity of Symptoms (SS) questionnaires, impact of FM in daily life (Fibromyalgia Impact Questionnaire: FIQ) and quality of live. Assessments are made at baseline, one month following the 6th session, and during the 6- and 12-month follow-up.

Eligibility criteria: Inclusion Criteria:

* Women with FM (2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia)
* Women ≥ 18 years
* Agree to participate in the study and sign informed consent.

Exclusion Criteria:

* Oncological pain
* Motor control alteration that prevents the execution of the planned PE program
* Patients with associated pathologies that make it impossible to perform physical exercise program
* Any disabling mental illness or intellectual deficit that prevents understanding the contents of PNE program

Primary outcomes:
measure: Fulfillment of diagnostic criteria for fibromyalgia
timeFrame: Change from baseline to 12 months follow-up
Secondary outcomes:
measure: Impact of fibromyalgia on daily life
timeFrame: Change from baseline to 12 months follow-up
measure: Catastrophism
timeFrame: Change from baseline to 12 months follow-up
measure: Anxiety
timeFrame: Change in score from baseline to 12 months follow-up
measure: Depression
timeFrame: Change in score of both subscales from baseline to 12 months follow-up
measure: Pain intensity
timeFrame: Change from baseline to 12 months follow-up
measure: Impact of pain in person's daily performance
timeFrame: Change from baseline to 12 months follow-up
measure: Functional capacity
timeFrame: Change from baseline to 12 months follow-up
Other outcomes:
Locations:
city: Burgos
country: Spain
facility: Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)
Study officials:
affiliation: Gerencia de Atención Primaria de Burgos. Castilla-León Health Service (Sacyl)
name: Pilar San Teodoro-Blanco, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Areso-Boveda PB, Mambrillas-Varela J, Garcia-Gomez B, Moscosio-Cuevas JI, Gonzalez-Lama J, Arnaiz-Rodriguez E, Del Barco MBA, Teodoro-Blanco PS. Effectiveness of a group intervention using pain neuroscience education and exercise in women with fibromyalgia: a pragmatic controlled study in primary care. BMC Musculoskelet Disord. 2022 Apr 4;23(1):323. doi: 10.1186/s12891-022-05284-y.