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Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

Primary Purpose

Fibromyalgia

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Pain Neuroscience Education and Physical Exercise
Sponsored by
Maimónides Biomedical Research Institute of Córdoba
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia focused on measuring Central Nervous System Sensitization, Chronic pain, Fibromyalgia, Neuroscience, Patient education

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention

Control

Arm Description

Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later

Standard of care.

Outcomes

Primary Outcome Measures

Fulfillment of diagnostic criteria for fibromyalgia
2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia: dichotomous variable (complies or does not comply). A patient satisfies diagnostic criteria for fibromyalgia if the following 3 conditions are met: Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9. Symptoms have been present at a similar level for at least 3 months. The patient does not have a disorder that would otherwise explain the pain. WPI: number of areas in which the patient has had pain over the last week (score between 0 and 19), with 0 = fully active and 5 = dead). SS: sum of the severity of 3 symptoms (fatigue, waking unrefreshed, cognitive symptoms) plus the extent (severity) of somatic symptoms in general (final score between 0 and 12: higher scores mean a worse outcome)

Secondary Outcome Measures

Impact of fibromyalgia on daily life
Evaluation of physical functionality, global impact and severity of symptoms: Fibromyalgia Impact Questionnaire (FIQ), which ranges from 0 to 100, with higher scores indicating worse outcome
Catastrophism
Pain-related catastrophizing behaviours and cognitions of individuals: Pain Catastrophizing Scale (PCS), which ranges from 0 to 52, with higher scores indicating worse outcome
Anxiety
Anxiety sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome
Depression
Depression sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome
Pain intensity
Pain intensity sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-40, with higher scores indicating worse outcome
Impact of pain in person's daily performance
Pain impact sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-70, with higher scores indicating worse outcome
Functional capacity
Difficulty in performing activities of daily living: Health Assessment Questionnaire (HAQ), which ranges from 0 to 60, with higher scores indicating worse outcome

Full Information

First Posted
August 26, 2020
Last Updated
August 31, 2020
Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Castilla-León Health Service
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1. Study Identification

Unique Protocol Identification Number
NCT04539171
Brief Title
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

2. Study Status

Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
January 15, 2018 (Actual)
Primary Completion Date
October 31, 2019 (Actual)
Study Completion Date
October 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Maimónides Biomedical Research Institute of Córdoba
Collaborators
Castilla-León Health Service

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
Keywords
Central Nervous System Sensitization, Chronic pain, Fibromyalgia, Neuroscience, Patient education

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Quasi-experimental, controlled, non-randomized study
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
53 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention
Arm Type
Experimental
Arm Description
Pain neuroscience education (Health education) and Physical exercise program: 6 weekly sessions (2 hours each), and a reminder session one month later
Arm Title
Control
Arm Type
No Intervention
Arm Description
Standard of care.
Intervention Type
Other
Intervention Name(s)
Pain Neuroscience Education and Physical Exercise
Intervention Description
Patients assigned to the experimental group perform a PNE program consisting of seven sessions, with therapeutic PE. PNE is a health education intervention aims to provide up-to-date information on neuroscience advances in the field of chronic pain.
Primary Outcome Measure Information:
Title
Fulfillment of diagnostic criteria for fibromyalgia
Description
2010 American College of Rheumatology Diagnostic Criteria for fibromyalgia: dichotomous variable (complies or does not comply). A patient satisfies diagnostic criteria for fibromyalgia if the following 3 conditions are met: Widespread pain index (WPI) ≥7 and symptom severity (SS) scale score ≥5 or WPI 3-6 and SS scale score ≥9. Symptoms have been present at a similar level for at least 3 months. The patient does not have a disorder that would otherwise explain the pain. WPI: number of areas in which the patient has had pain over the last week (score between 0 and 19), with 0 = fully active and 5 = dead). SS: sum of the severity of 3 symptoms (fatigue, waking unrefreshed, cognitive symptoms) plus the extent (severity) of somatic symptoms in general (final score between 0 and 12: higher scores mean a worse outcome)
Time Frame
Change from baseline to 12 months follow-up
Secondary Outcome Measure Information:
Title
Impact of fibromyalgia on daily life
Description
Evaluation of physical functionality, global impact and severity of symptoms: Fibromyalgia Impact Questionnaire (FIQ), which ranges from 0 to 100, with higher scores indicating worse outcome
Time Frame
Change from baseline to 12 months follow-up
Title
Catastrophism
Description
Pain-related catastrophizing behaviours and cognitions of individuals: Pain Catastrophizing Scale (PCS), which ranges from 0 to 52, with higher scores indicating worse outcome
Time Frame
Change from baseline to 12 months follow-up
Title
Anxiety
Description
Anxiety sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome
Time Frame
Change in score from baseline to 12 months follow-up
Title
Depression
Description
Depression sub-scale of the Hospital Anxiety and Depression Scale (HAD), which ranges from 0 to 21, with higher scores indicating worse outcome
Time Frame
Change in score of both subscales from baseline to 12 months follow-up
Title
Pain intensity
Description
Pain intensity sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-40, with higher scores indicating worse outcome
Time Frame
Change from baseline to 12 months follow-up
Title
Impact of pain in person's daily performance
Description
Pain impact sub-scale of the Brief Pain Questionnaire (BPI), which ranges between 0-70, with higher scores indicating worse outcome
Time Frame
Change from baseline to 12 months follow-up
Title
Functional capacity
Description
Difficulty in performing activities of daily living: Health Assessment Questionnaire (HAQ), which ranges from 0 to 60, with higher scores indicating worse outcome
Time Frame
Change from baseline to 12 months follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pilar San Teodoro-Blanco, MD
Organizational Affiliation
Gerencia de Atención Primaria de Burgos. Castilla-León Health Service (Sacyl)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Unidad de Fisioterapia Burgos Centro. GAP Burgos (Sacyl)
City
Burgos
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
We plan to share IPD, upon reasonable request, at the time the data be published. We will share all IPD that underlie results in a publication.
IPD Sharing Time Frame
At the time the study results are published.
IPD Sharing Access Criteria
Upon reasonable request after an individualized evaluation of each request by the research team.
Citations:
PubMed Identifier
35379222
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.
Results Reference
derived

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Pain Neuroscience Education and Physical Exercise Program in Fibromyalgia

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