Clinical trial NCT05890326: Pain Neuroscience Education and Motor Imagery-based Exercise Protocol for Patients With Fibromyalgia
Official title: Pain Neuroscience Education and Motor Imagery-based Exercise Protocol in Fibromyalgia
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Fibromyalgia
Pain
Psychology Regression
Lead sponsor: Uskudar University
Sponsor class: OTHER
First posted: 2023-06-06
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The main aim of this study is to find out whether applying both pain neuroscience education (PNE) and motor imagery-based exercise protocol (MIEP) will primarily reduce the pain of fibromyalgia. These therapies could show an evidence of improvement in fibromyalgia patients. However, there are no studies evaluating their effectiveness in combination.

Secondary outcomes:

To assess motor imagery ability of PNE in fibromyalgia patients

To assess motor imagery ability of MIEP in fibromyalgia patients

To evaluate the motor imagery ability of PNE+MIEP combined in fibromyalgia patients

To evaluate pain beliefs of PNE in fibromyalgia patients

To assess the pain beliefs of MIEP in fibromyalgia patients

Combined PNE+MIEP to assess pain beliefs in fibromyalgia patients.

To assess fear of movement in fibromyalgia patients of PNE

To assess fear of movement in fibromyalgia patients of MIEP

Combined PNE+MIEP to assess fear of movement in patients with fibromyalgia

PNE to assess anxiety, depression, cognitive and mood in patients with fibromyalgia.

To assess anxiety, depression, cognitive and mood in patients with fibromyalgia MIEP

To evaluate anxiety, depression, cognitive and mood in patients with fibromyalgia together with PNE+MIEP

PNE to assess self-esteem and body awareness in fibromyalgia patients.

To assess self-esteem and body awareness in fibromyalgia patients of MIEP

Combined PNE+MIEP to assess self-esteem and body awareness in fibromyalgia patients.


Eligibility criteria: Inclusion Criteria:

* Experiencing widespread chronic pain for more than 12 months
* Pain in at least 12 or more of 18 tender points with a pressure of 5 kg/cm2
* 18 to 60 years old
* Not using pharmacological therapeutics
* Not having participated in any pain program.
* Not having participated in any physical exercise programs in the last twelve

Exclusion Criteria:

* Pregnancy
* Not being able to do a physical activity program
* Currently receiving treatment with any alternative medical methods (eg.hyperbaric).
* Cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease
* Other causes of chronic pain
* Receiving any treatment support related to pain
* Mental disability status

Primary outcomes:
measure: Visual Analogue Scale (VAS)
timeFrame: 12 weeks
Secondary outcomes:
measure: Hospital Anxiety and Depression Scale (HADS)
timeFrame: 12 weeks
measure: The Motion Imagery Questionnaire-3 (HLFS-3)
timeFrame: 12 weeks
measure: The Pain Beliefs Questionnaire (PBQ)
timeFrame: 12 weeks
measure: The Pain Catastrophizing Scale (PCS)
timeFrame: 12 weeks
measure: The Tampa Scale for Kinesiophobia (TSK)
timeFrame: 12 weeks
measure: Adapting the Scale of Cognitive Emotion Regulation Strategies
timeFrame: 12 weeks
measure: Rosenberg Self-esteem Scale
timeFrame: 12 weeks
measure: The Body Awareness Questionnaire
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Istanbul
country: Turkey
facility: Uskudar University
Study officials:
affiliation: Üsküdar University
name: Selin Kırcali, Msc
role: STUDY_DIRECTOR
References: