Therapeutic Neuroscience Education in Individuals With Fibromyalgia

Pamukkale University25 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Fibromyalgia

Interventions

Therapeutic Neuroscience EducationBEHAVIORAL

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.

Eligibility

Sex: FEMALEMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (1)

Pamukkale University

Denizli, Merkezefendi, Turkey (Türkiye)

Outcomes

Primary Outcomes

Fibromyalgia Impact Questionnare

Total score ranging from 0 to 100. Higher scores indicate worse functional status

Time frame: 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.

Time frame: 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.

Time frame: 10 min

Symptom Severity Scale

The SSS is scored between 0-12.

Time frame: 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.

Time frame: 7 min

Pain Catastrophizing Scale

The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.

Time frame: 10 min

Tampa Scale for Kinesiophobia

The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.

Time frame: 10 min

Secondary Outcomes

Data from ClinicalTrials.gov

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