Therapeutic Neuroscience Education in Individuals With Fibromyalgia
- Conditions
- Fibromyalgia
- Interventions
- Behavioral: Therapeutic Neuroscience Education
- Registration Number
- NCT05435807
- Lead Sponsor
- Pamukkale University
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 25
- 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).
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description intervention group Therapeutic Neuroscience Education Clinical Pilates Exercises+TNE control group Therapeutic Neuroscience Education Clinical Pilates Exercises
- Primary Outcome Measures
Name Time Method Brief Pain Inventory 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.
Tampa Scale for Kinesiophobia 10 min The total score ranges from 17 to 68, with a higher score indicating high kinesiophobia.
Widespread Pain Index 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 7 min The SSS is scored between 0-12.
Fibromyalgia Impact Questionnare 10 min Total score ranging from 0 to 100. Higher scores indicate worse functional status
Visual Analogue Scale 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.
Pain Catastrophizing Scale 10 min The total score ranges from 0 to 52, with higher scores indicating a high level of catastrophizing.
- Secondary Outcome Measures
Name Time Method Dynamic Loewenstein Occupational Therapy Cognitive Assessment 1 hour The 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 Questionnaire 10 min It includes 30 items that are answered using a 5-point Likert-type scale. Higher scores indicate a poor biopsychosocial status.
Trial Locations
- Locations (1)
Pamukkale University
🇹🇷Denizli, Merkezefendi, Turkey