FibromyalgiaNCT05435807
Therapeutic Neuroscience Education in Individuals With Fibromyalgia
A study testing Therapeutic Neuroscience Education in people with Fibromyalgia, run by Pamukkale University at 1 site in Turkey (Türkiye).
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Fibromyalgia
- What is being tested?
- Therapeutic Neuroscience Education
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jun 2019to 15 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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),
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- 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.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Pamukkale University
Denizli, Merkezefendi, 20070
About this study
Official title: Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
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).
- Conditions
- Fibromyalgia
- Being tested
- Therapeutic Neuroscience Education
- Medical subject headings
- Fibromyalgia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Therapeutic Neuroscience EducationBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| intervention group | Experimental | Clinical Pilates Exercises+TNE Receives: Behavioral: Therapeutic Neuroscience Education |
| control group | Experimental | Clinical Pilates Exercises Receives: Behavioral: Therapeutic Neuroscience Education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Fibromyalgia Impact Questionnare
Total score ranging from 0 to 100. Higher scores indicate worse functional status
Measured: 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.
Measured: 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.
Measured: 10 min
Symptom Severity Scale
The SSS is scored between 0-12.
Measured: 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.
Measured: 7 min
Pain Catastrophizing Scale
The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
Measured: 10 min
Tampa Scale for Kinesiophobia
The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
Measured: 10 min
Secondary outcomes (2)
Biopsychosocial Questionnaire
It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.
Measured: 10 min
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).
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2022
- Study start1 Jun 2019
- Primary completion20 Dec 2020
- Study completion15 Jun 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FibromyalgiaStudies of the same condition, open and under way.
- More trials run by Pamukkale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pamukkale University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elif Gur Kabul, Pamukkale University
- Investigators
- Bilge Basakcı Calık, Prof., Principal investigator, Pamukkale UniversityUmmuhan Bas ASLAN, Prof., Principal investigator, Pamukkale UniversityUğur Karasu, MD, Principal investigator, Pamukkale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05435807
- Sponsor's protocol ID
- Neuroscience Education
- Status last verified
- Jun 2022
- First submitted
- 18 Jun 2022
- Last updated
- 28 Jun 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigation Of The Efficacy Of Therapeutic Neuroscience Education In Individuals With Fibromyalgia: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05435807
- Acronym / sponsor ID
- Neuroscience Education
- Conditions
- Fibromyalgia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Pamukkale UniversityUniversity, hospital or other
- Study start
- 1 Jun 2019 (actual)
- Primary completion
- 20 Dec 2020 (actual)
- Study completion
- 15 Jun 2021 (actual)
- First posted
- 28 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention group | Experimental | Behavioral: Therapeutic Neuroscience EducationClinical Pilates Exercises+TNE |
| control group | Experimental | Behavioral: Therapeutic Neuroscience EducationClinical Pilates Exercises |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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).
Key exclusion criteria (10 listed)
- 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,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Therapeutic Neuroscience EducationTherapeutic 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. | Behavioural | control group, intervention group |
Primary outcome
Fibromyalgia Impact Questionnare
Time frame: 10 min
Total score ranging from 0 to 100. Higher scores indicate worse functional status
Visual Analogue Scale
Time frame: 5 min
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
Time frame: 10 min
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
Time frame: 7 min
The SSS is scored between 0-12.
Brief Pain Inventory
Time frame: 7 min
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
Time frame: 10 min
The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
Tampa Scale for Kinesiophobia
Time frame: 10 min
The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
2 secondary outcomes
Biopsychosocial Questionnaire
Time frame: 10 min
Dynamic Loewenstein Occupational Therapy Cognitive Assessment
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jun 2022.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bilge Basakcı Calık, Prof. principal investigator
Pamukkale University
Ummuhan Bas ASLAN, Prof. principal investigator
Pamukkale University
Uğur Karasu, MD principal investigator
Pamukkale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Therapeutic Neuroscience Education in people with Fibromyalgia, run by Pamukkale University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Fibromyalgia Impact Questionnare (time frame: 10 min). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jun 2022.