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Effectiveness of Pain Science Education in Patients With Fibromyalgia Syndrome Living in Rural Areas.

M

María Catalina Osuna Pérez

Status

Enrolling

Conditions

Fibromyalgia Syndrome

Treatments

Procedure: Pain Science Education

Study type

Interventional

Funder types

Other

Identifiers

NCT07280273
PSE-RURAL

Details and patient eligibility

About

Fibromyalgia Syndrome (FMS) is a complex chronic pain disorder characterized by widespread pain associated with numerous symptoms. It is more common in women over 50 years of age with low educational and socioeconomic status living in rural areas. Pain Science Education (PSE) is one of the most widely used treatments for chronic pain management. This treatment consists of an educational intervention aimed at reconceptualizing and modifying erroneous cognitions regarding pain in these patients.

The objective of this study is to evaluate the effectiveness of PSE in patients with FMS living in rural areas. They will be randomly assigned to one of two treatment groups. The intervention group will receive two adapted in-person sessions (90 minutes per session/week) by a therapist experienced in teaching PSE. The control group will begin the conventional treatment they received before participating in the study. After the end of the study, patients in the control group will be given their intervention group records. The variables measured will include the impact of FMS on daily life, pain sensitivity, central sensitization, pain catastrophizing, fear of movement, anxiety and depression, self-efficacy, and assessment of knowledge and beliefs about PSE. Assessments will be conducted before the intervention, after the second PSE session, and three months later by the same researcher.

Enrollment

54 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Diagnosis of FM that meets the 2016 American College of Rheumatology (ACR) diagnostic criteria.
  • Residence in a rural area of the province of Jaén (Spain).
  • Age between 18 and 65 years.
  • Spanish reading ability.
  • Understanding and acceptance of the informed consent form to participate in the study.

Exclusion criteria

  • -Patients diagnosed with any mental illness that prevents adherence to the intervention.
  • Patients diagnosed with inflammatory rheumatic disease.
  • Having a scheduled surgical intervention during the data collection process that could interfere with the results.
  • Being pregnant or breastfeeding.
  • Modification of pharmacological treatment during the study or in the last three months before the intervention.

These criteria have been established from a review of other clinical trials conducted with similar interventions in patients with FMS.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

54 participants in 2 patient groups

PSE group
Experimental group
Treatment:
Procedure: Pain Science Education
Control group
No Intervention group

Trial contacts and locations

1

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Central trial contact

María Catalina Osuna-Pérez, PhD; Noelia Zagalaz-Anula, PhD

Data sourced from clinicaltrials.gov

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