Therapeutic Neuroscience Education in Individuals With Fibromyalgia

NCT ID: NCT05435807

Last Updated: 2022-06-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-06-01

Study Completion Date

2021-06-15

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).

Detailed Description

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Conditions

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Fibromyalgia

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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intervention group

Clinical Pilates Exercises+TNE

Group Type EXPERIMENTAL

Therapeutic Neuroscience Education

Intervention Type BEHAVIORAL

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.

control group

Clinical Pilates Exercises

Group Type EXPERIMENTAL

Therapeutic Neuroscience Education

Intervention Type BEHAVIORAL

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.

Interventions

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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.

Intervention Type BEHAVIORAL

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Pamukkale University

OTHER

Sponsor Role lead

Responsible Party

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Elif Gur Kabul

research assistant

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Bilge Basakcı Calık, Prof.

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Ummuhan Bas ASLAN, Prof.

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Uğur Karasu, MD

Role: PRINCIPAL_INVESTIGATOR

Pamukkale University

Locations

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Pamukkale University

Denizli, Merkezefendi, Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Other Identifiers

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Neuroscience Education

Identifier Type: -

Identifier Source: org_study_id

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