Therapeutic Neuroscience Education in Individuals With Fibromyalgia

Study Overview
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Brief Summary
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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).

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

Conditions
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Fibromyalgia

Intervention / Treatment
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* Behavioral: Therapeutic Neuroscience Education


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: intervention group<br>Clinical Pilates Exercises+TNE | Behavioral: Therapeutic Neuroscience Education<br>* 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.<br>|
| Experimental: control group<br>Clinical Pilates Exercises | Behavioral: Therapeutic Neuroscience Education<br>* 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.<br>|

What is the study measuring?
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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 |