Therapeutic Neuroscience Education in Individuals With Fibromyalgia
Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
1 other identifier
interventional
25
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 15, 2021
CompletedFirst Submitted
Initial submission to the registry
June 18, 2022
CompletedFirst Posted
Study publicly available on registry
June 28, 2022
CompletedJune 28, 2022
June 1, 2022
1.6 years
June 18, 2022
June 23, 2022
Conditions
Outcome Measures
Primary Outcomes (7)
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 Outcomes (2)
Biopsychosocial Questionnaire
10 min
Dynamic Loewenstein Occupational Therapy Cognitive Assessment
1 hour
Study Arms (2)
intervention group
EXPERIMENTALClinical Pilates Exercises+TNE
control group
EXPERIMENTALClinical Pilates Exercises
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.
Eligibility Criteria
You may qualify if:
- 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).
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Pamukkale University
Denizli, Merkezefendi, 20070, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Bilge Basakcı Calık, Prof.
Pamukkale University
- PRINCIPAL INVESTIGATOR
Ummuhan Bas ASLAN, Prof.
Pamukkale University
- PRINCIPAL INVESTIGATOR
Uğur Karasu, MD
Pamukkale University
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- research assistant
Study Record Dates
First Submitted
June 18, 2022
First Posted
June 28, 2022
Study Start
June 1, 2019
Primary Completion
December 20, 2020
Study Completion
June 15, 2021
Last Updated
June 28, 2022
Record last verified: 2022-06