Pain Neuroscience Education and Motor Imagery-based Exercise Protocol for Patients With Fibromyalgia
- Conditions
- FibromyalgiaPainPsychology Regression
- Interventions
- Behavioral: Pain neuroscience education (PNE)Behavioral: Combination GroupBehavioral: Motor imagery-based exercise protocol (MIEP)
- Registration Number
- NCT05890326
- Lead Sponsor
- Uskudar University
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Pain neuroscience education (PNE) Pain neuroscience education (PNE) Pain neuroscience education (PNE) applied in this group. Combination Group Combination Group Both Pain neuroscience education (PNE) and Motor imagery-based exercise protocol (MIEP) applied in this group. Motor imagery-based exercise protocol (MIEP) Motor imagery-based exercise protocol (MIEP) Motor imagery-based exercise protocol (MIEP) applied in this group.
- Primary Outcome Measures
Name Time Method Visual Analogue Scale (VAS) 12 weeks Using a ruler, the score is determined by measuring the distance (mm) on the 10-cm line between the "no pain" anchor and the patient's mark, providing a range of scores from 0-100. A higher score indicates greater pain intensity.
- Secondary Outcome Measures
Name Time Method The Pain Catastrophizing Scale (PCS) 12 weeks The Pain Catastrophizing Scale (PCS) is a 13-item self-report measure designed to assess catastrophic thinking related to pain among adults with or without chronic pain. Patients are asked to rate the degree to which they have any of the thoughts described in the questionnaire using a 5-point Likert scale ranging from 0 (never) to 4 (always). The total score is the sum of the scores for the individual items, and ranges from 0 to 52.
The Pain Beliefs Questionnaire (PBQ) 12 weeks The Pain Beliefs Questionnaire (PBQ), a 32-item self-report measure of the pain beliefs of children and adolescents with chronic pain, assesses cognitive appraisals that may influence children's coping strategies, disability, mood, and pain severity. For each item on the PBQ, respondents indicate how true the statement is on a 5-point rating scale ranging from "not at all true" (0) to "very true" (4). Subscale total scores are computed by averaging items pertaining to each subscale.
Rosenberg Self-esteem Scale 12 weeks Rosenberg self-esteem scale is: The scale ranges from 0-30. Scores between 15 and 25 are within normal range; scores below 15 suggest low self-esteem.
Adapting the Scale of Cognitive Emotion Regulation Strategies 12 weeks The scale aims to determine the level of cognitive emotion regulation strategies used by a person against a particular event or events in general, regardless of clinical or non-clinical distinction. The scale, consisting of 36 items and 9 sub-dimensions, has a five-point Likert-type rating (1 = never, 2 = rarely, 3 = sometimes, 4 = often, 5 = always). There are 4 items in each sub-dimension and the lowest score from a sub-dimension is 4 and the highest score is 20.
The Motion Imagery Questionnaire-3 (HLFS-3) 12 weeks The Motion Imagery Questionnaire-3 (HLFS-3) is an adaptation of the Motion Imagery Questionnaire. It consists of 3 subscales and a total of 12 items evaluating external visual imagery, internal visual imagery and kinesthetic imagery. Before starting the evaluation, the participants were given the necessary information about the survey. Each of the 12 tasks in the questionnaire was first performed physically, then the participant returned to the starting position and imaged according to the desired imagery type.
Scoring was made between 1 and 7, with 1 point: very difficult to see/feel, 7 points: very easy to see/feel. While calculating the score, the internal visual imagery, external visual imagery and kinesthetic imagery scores were added separately and averaged by dividing by 4. As a result, the score of each subscale was obtained.The Tampa Scale for Kinesiophobia (TSK) 12 weeks The Tampa Scale for Kinesiophobia (TSK) is a 17-item questionnaire that quantifies fear of movement. Individual item scores range from 1-4, with the negatively worded items (4,8,12,16) having a reverse scoring (4-1). The 17 item TSK total scores range from 17 to 68 where the lowest 17 means no or negligible kinesiophobia, and the higher scores indicate an increasing degree of kinesiophobia.
Hospital Anxiety and Depression Scale (HADS) 12 weeks HADS - One questionnaire, comprising of fourteen questions The questionnaire features seven questions for anxiety and seven for depression of which can be answered within 2 - 5 minutes. Responses are scored on a scale of 3 to 0 - The maximum score is therefore 21 for Anxiety and 21 for Depression.
Odd numbers: 1, 3, 5, 7, 9, 11 and 13 are Anxiety Questions (Grey in Colour) Even numbers: 2, 4, 6, 8, 10, 12 and 14 are Depression Questions (White in Colour)
The two sub-scales, anxiety and depression, have been found to be independent measures. In its current form the HADS is now divided into four stages:
Scores of: 0-7 (Normal) 8-10 (Mild) 11-15 (Moderate) 16-21 (Severe)The Body Awareness Questionnaire 12 weeks The body awareness questionnaire is a 18 item scale, with the total scale score calculated as a sum of the items. Items are scored on a 1-7 scale, with the total scale score calculated as a sum of the items. The questions with asterisks are reverse scored.
Trial Locations
- Locations (1)
Uskudar University
🇹🇷Istanbul, Turkey