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Therapeutic Neuroscience Education in Individuals With Fibromyalgia

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05435807
Enrollment
25
Registered
2022-06-28
Start date
2019-06-01
Completion date
2021-06-15
Last updated
2022-06-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Fibromyalgia

Brief summary

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).

Interventions

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.

Sponsors

Pamukkale University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Tampa Scale for Kinesiophobia10 minThe total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
Brief Pain Inventory7 minThis 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.
Pain Catastrophizing Scale10 minThe total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
Fibromyalgia Impact Questionnare10 minTotal score ranging from 0 to 100. Higher scores indicate worse functional status
Visual Analogue Scale5 minVAS 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.
Widespread Pain Index10 minThe WPI evaluates the patient's pain in the last week in terms of 19 regions and is scored between 0-19.
Symptom Severity Scale7 minThe SSS is scored between 0-12.

Secondary

MeasureTime frameDescription
Dynamic Loewenstein Occupational Therapy Cognitive Assessment1 hourThe DLOTCA battery has 28 subtests for 7 cognitive areas.Scoring consists of three components for each subtest: 1. Before meditation score (5 points indicate the best performance). 2. Mediation score (high score (4 or 5) indicates poor performance). 3. After mediation score (5 points show the best performance).
Biopsychosocial Questionnaire10 minIt includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026