Therapeutic Neuroscience Education in Individuals With Fibromyalgia

Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial

The aim of this study was to investigate the effects of Therapeutic Neuroscience Education (TNE) in individuals with Fibromyalgia (FM). The study included 25 females with FM, randomly separated into two groups as the intervention group (Clinical Pilates Exercises+TNE, n=11) and the control group (Clinical Pilates Exercises, n=14).

Study Overview

• Status: Completed
• Conditions: Fibromyalgia
• Intervention / Treatment: Behavioral: Therapeutic Neuroscience Education

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Turkey
  • Merkezefendi
    • Denizli, Merkezefendi, Turkey, 20070
      • Pamukkale University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• age between 18-65 years,
• female gender,
• a VAS of at least 40mm to report the pain intensity of the last week,
• having been diagnosed with FM for at least 1 year to present a range of somatic and cognitive symptoms in addition to widespread pain,
• using a fixed dose of medication for at least the past 6 months (serotonin noradrenaline reuptake inhibitors [Ex, duloxetine, milnacipran]; alpha 2-delta receptor ligand [Ex, pregabalin]; gabapentinoids).

Exclusion Criteria:

• the presence of another disease which may affect the physical condition,
• cognitive impairment at a level preventing cooperation,
• being pregnant,
• inability to understand or speak Turkish,
• concurrent autoimmune or inflammatory disease,
• the presence of a central nervous system disease (eg multiple sclerosis, Parkinson's disease),
• serious psychiatric conditions (eg, psychotic disorders) that would prevent participation,
• participation in a rehabilitation program in the past year,
• have been exercising regularly for 6 months,
• not participating in at least 75% of treatments.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: NONE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: intervention group; Clinical Pilates Exercises+TNE	Behavioral: Therapeutic Neuroscience Education; Therapeutic Neuroscience Education (TNE) is an intervention used by physiotherapists, which can be defined as a cognitive behavioral therapy method. By helping patients better understand the biological process that underlies their painful condition, it aims to achieve therapeutic effects such as reducing pain and the fear associated with musculoskeletal injuries and increasing movement and functionality.
EXPERIMENTAL: control group; Clinical Pilates Exercises	Behavioral: Therapeutic Neuroscience Education; Therapeutic Neuroscience Education (TNE) is an intervention used by physiotherapists, which can be defined as a cognitive behavioral therapy method. By helping patients better understand the biological process that underlies their painful condition, it aims to achieve therapeutic effects such as reducing pain and the fear associated with musculoskeletal injuries and increasing movement and functionality.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Fibromyalgia Impact Questionnare	Total score ranging from 0 to 100. Higher scores indicate worse functional status	10 min
Visual Analogue Scale	VAS is used to convert values that cannot be measured numerically, such as pain, into numerical values. Two end definitions of the parameter to be evaluated are written at the two ends of a 10 cm line and the patient is asked to mark this line indicating the appropriate level of their condition. In this study, 0='no pain' and 10='worst possible pain' were defined.	5 min
Widespread Pain Index	The WPI evaluates the patient's pain in the last week in terms of 19 regions and is scored between 0-19.	10 min
Symptom Severity Scale	The SSS is scored between 0-12.	7 min
Brief Pain Inventory	This is a short and easy-to-apply inventory that can be used to assess pain, which consists of the two sections of Pain Severity (4 items) and Pain Interference (7 items). The total score in both categories ranges from 0 to 10, with higher scores indicating more pain and more pain causes more disability.	7 min
Pain Catastrophizing Scale	The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.	10 min
Tampa Scale for Kinesiophobia	The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.	10 min

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Biopsychosocial Questionnaire	It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.	10 min
Dynamic Loewenstein Occupational Therapy Cognitive Assessment	The DLOTCA battery has 28 subtests for 7 cognitive areas.Scoring consists of three components for each subtest: Before meditation score (5 points indicate the best performance).; Mediation score (high score (4 or 5) indicates poor performance).; After mediation score (5 points show the best performance).	1 hour

Collaborators and Investigators

• Sponsor: Pamukkale University
• Investigators: Principal Investigator: Bilge Basakcı Calık, Prof., Pamukkale University; Principal Investigator: Ummuhan BAŞ ASLAN, Prof., Pamukkale University; Principal Investigator: Uğur Karasu, MD, Pamukkale University

Study record dates

Study Major Dates

• Study Start (ACTUAL): June 1, 2019
• Primary Completion (ACTUAL): December 20, 2020
• Study Completion (ACTUAL): June 15, 2021

Study Registration Dates

• First Submitted: June 18, 2022
• First Submitted That Met QC Criteria: June 23, 2022
• First Posted (ACTUAL): June 28, 2022

Study Record Updates

• Last Update Posted (ACTUAL): June 28, 2022
• Last Update Submitted That Met QC Criteria: June 23, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Muscular Diseases; Neuromuscular Diseases; Fibromyalgia; Myofascial Pain Syndromes
• Other Study ID Numbers: Neuroscience Education

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No