Back to resultsTherapeutic Neuroscience Education in Individuals With Fibromyalgia
Primary Purpose
Fibromyalgia
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Therapeutic Neuroscience Education
Sponsored by
About this trial
This is an interventional treatment trial for Fibromyalgia
Eligibility Criteria
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.
Sites / Locations
- Pamukkale University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
intervention group
control group
Arm Description
Clinical Pilates Exercises+TNE
Clinical Pilates Exercises
Outcomes
Primary Outcome Measures
Fibromyalgia Impact Questionnare
Total score ranging from 0 to 100. Higher scores indicate worse functional status
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.
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.
Symptom Severity Scale
The SSS is scored between 0-12.
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.
Pain Catastrophizing Scale
The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
Tampa Scale for Kinesiophobia
The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
Secondary Outcome Measures
Biopsychosocial Questionnaire
It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.
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).
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05435807
Brief Title
Therapeutic Neuroscience Education in Individuals With Fibromyalgia
Official Title
Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
June 1, 2019 (Actual)
Primary Completion Date
December 20, 2020 (Actual)
Study Completion Date
June 15, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Pamukkale University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
intervention group
Arm Type
Experimental
Arm Description
Clinical Pilates Exercises+TNE
Arm Title
control group
Arm Type
Experimental
Arm Description
Clinical Pilates Exercises
Intervention Type
Behavioral
Intervention Name(s)
Therapeutic Neuroscience Education
Intervention Description
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.
Primary Outcome Measure Information:
Title
Fibromyalgia Impact Questionnare
Description
Total score ranging from 0 to 100. Higher scores indicate worse functional status
Time Frame
10 min
Title
Visual Analogue Scale
Description
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
Title
Widespread Pain Index
Description
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
Title
Symptom Severity Scale
Description
The SSS is scored between 0-12.
Time Frame
7 min
Title
Brief Pain Inventory
Description
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
Title
Pain Catastrophizing Scale
Description
The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
Time Frame
10 min
Title
Tampa Scale for Kinesiophobia
Description
The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
Time Frame
10 min
Secondary Outcome Measure Information:
Title
Biopsychosocial Questionnaire
Description
It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.
Time Frame
10 min
Title
Dynamic Loewenstein Occupational Therapy Cognitive Assessment
Description
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).
Time Frame
1 hour
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bilge Basakcı Calık, Prof.
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Ummuhan Bas ASLAN, Prof.
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Uğur Karasu, MD
Organizational Affiliation
Pamukkale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Pamukkale University
City
Denizli
State/Province
Merkezefendi
ZIP/Postal Code
20070
Country
Turkey
12. IPD Sharing Statement
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Therapeutic Neuroscience Education in Individuals With Fibromyalgia
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