FibromyalgiaNCT05890326
Pain Neuroscience Education and Motor Imagery-based Exercise Protocol for Patients With Fibromyalgia
A study testing Pain neuroscience education (PNE), Motor imagery-based exercise protocol (MIEP) and Combination Group in people with Fibromyalgia and Pain, run by Uskudar University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Fibromyalgia, Pain, Psychology Regression
- What is being tested?
- Pain neuroscience education (PNE), Motor imagery-based exercise protocol (MIEP) and Combination Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 20 Nov 2022to 2 May 2023
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pain Neuroscience Education and Motor Imagery-based Exercise Protocol in Fibromyalgia
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:
Read more
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.
- Conditions
- Fibromyalgia, Pain, Psychology Regression
- Being tested
- Pain neuroscience education (PNE), Motor imagery-based exercise protocol (MIEP), Combination Group
- Medical subject headings
- Fibromyalgia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pain neuroscience education (PNE)Behavioural
Pain neuroscience education (PNE) is a health education intervention that aims to provide up-to-date information on neuroscience developments in the field of chronic pain. All patients were trained once a week for 12 weeks, in groups of 3-4 people, for a maximum of 6 sessions and a minimum of 60 minutes. During the intervention, psychological factors such as self-efficacy, pain intervention/injury, coping with pain, catastrophic thoughts, emotional response to pain, anxiety, frustration/anger, fear of harm, concerns about pain, and fear of pain were examined. and discussed with patients. The sessions aimed to provide patients with a better understanding of their chronic pain by addressing the multifactorial aspects of chronic pain, sensitization and the plasticity of the brain, thus involving patients in treatment.
Motor imagery-based exercise protocol (MIEP)Behavioural
All patients performed sessions of maximum 60 minutes in groups of 3-4 people twice a week for 12 weeks. This study protocol was developed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The key standard was to practice simple and safe exercises that would encourage the patient to repeat the program at home. The exercises proposed in MIEP were selected according to the following principles: slowness, painlessness, arousing attention, easy to imagine. The main purpose of the motor imagery exercises was to bring the patient back to the state of "feeling and self-perception" of the execution of the movement. More important than the "quantity" of repetition was the painless "quality" of movement. It was performed in 3 phases: relaxation (3 minutes), MI (8.5 minutes per image) and refocus (3 minutes), which included both kinesthetic imagery (KI) and visual imagery (VI).
Combination GroupBehavioural
Subjects received 6 sessions of Pain neuroscience education (PNE) and 12 weeks (2 times a week) of Motor imagery-based exercise protocol (MIEP).
| Study group | Role | What they receive |
|---|---|---|
| Control group | No intervention | No intervention was applied to fibromyalgia patients in this group. This was because it was a control group that would evaluate the effects on outcomes by comparing them with other intervention (behavioral) groups. |
| Motor imagery-based exercise protocol (MIEP) | Experimental | Motor imagery-based exercise protocol (MIEP) applied in this group. Receives: Behavioral: Motor imagery-based exercise protocol (MIEP) |
| Pain neuroscience education (PNE) | Experimental | Pain neuroscience education (PNE) applied in this group. Receives: Behavioral: Pain neuroscience education (PNE) |
| Combination Group | Active comparator | Both Pain neuroscience education (PNE) and Motor imagery-based exercise protocol (MIEP) applied in this group. Receives: Behavioral: Combination Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale (VAS)
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.
Measured: 12 weeks
Secondary outcomes (8)
Hospital Anxiety and Depression Scale (HADS)
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)
Measured: 12 weeks
The Motion Imagery Questionnaire-3 (HLFS-3)
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.
Measured: 12 weeks
The Pain Beliefs Questionnaire (PBQ)
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.
Measured: 12 weeks
The Pain Catastrophizing Scale (PCS)
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.
Measured: 12 weeks
The Tampa Scale for Kinesiophobia (TSK)
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.
Measured: 12 weeks
Adapting the Scale of Cognitive Emotion Regulation Strategies
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.
Measured: 12 weeks
Rosenberg Self-esteem Scale
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.
Measured: 12 weeks
The Body Awareness Questionnaire
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.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2023
- Study start20 Nov 2022
- Primary completion14 Jan 2023
- Study completion2 May 2023
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.
- 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Uskudar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mesut Karahan, Uskudar University
- Investigators
- Selin Kırcali, Msc, Study director, Üsküdar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05890326
- Sponsor's protocol ID
- fibromyalgiaUSK
- Status last verified
- May 2023
- First submitted
- 16 May 2023
- Last updated
- 6 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Neuroscience Education and Motor Imagery-based Exercise Protocol in Fibromyalgia
- ClinicalTrials.gov ID
- NCT05890326
- Acronym / sponsor ID
- fibromyalgiaUSK
- Conditions
- Fibromyalgia, Pain, Psychology Regression
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Uskudar UniversityUniversity, hospital or other
- Study start
- 20 Nov 2022 (actual)
- Primary completion
- 14 Jan 2023 (actual)
- Study completion
- 2 May 2023 (actual)
- First posted
- 6 Jun 2023 (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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Control group | No intervention | –No intervention was applied to fibromyalgia patients in this group. This was because it was a control group that would evaluate the effects on outcomes by comparing them with other intervention (behavioral) groups. |
| Motor imagery-based exercise protocol (MIEP) | Experimental | Behavioral: Motor imagery-based exercise protocol (MIEP)Motor imagery-based exercise protocol (MIEP) applied in this group. |
| Pain neuroscience education (PNE) | Experimental | Behavioral: Pain neuroscience education (PNE)Pain neuroscience education (PNE) applied in this group. |
| Combination Group | Active comparator | Behavioral: Combination GroupBoth Pain neuroscience education (PNE) and Motor imagery-based exercise protocol (MIEP) applied in this group. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
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 |
|---|---|---|
| Pain neuroscience education (PNE)Pain neuroscience education (PNE) is a health education intervention that aims to provide up-to-date information on neuroscience developments in the field of chronic pain. All patients were trained once a week for 12 weeks, in groups of 3-4 people, for a maximum of 6 sessions and a minimum of 60 minutes. During the intervention, psychological factors such as self-efficacy, pain intervention/injury, coping with pain, catastrophic thoughts, emotional response to pain, anxiety, frustration/anger, fear of harm, concerns about pain, and fear of pain were examined. and discussed with patients. The sessions aimed to provide patients with a better understanding of their chronic pain by addressing the multifactorial aspects of chronic pain, sensitization and the plasticity of the brain, thus involving patients in treatment. | Behavioural | Pain neuroscience education (PNE) |
| Motor imagery-based exercise protocol (MIEP)All patients performed sessions of maximum 60 minutes in groups of 3-4 people twice a week for 12 weeks. This study protocol was developed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) guidelines. The key standard was to practice simple and safe exercises that would encourage the patient to repeat the program at home. The exercises proposed in MIEP were selected according to the following principles: slowness, painlessness, arousing attention, easy to imagine. The main purpose of the motor imagery exercises was to bring the patient back to the state of "feeling and self-perception" of the execution of the movement. More important than the "quantity" of repetition was the painless "quality" of movement. It was performed in 3 phases: relaxation (3 minutes), MI (8.5 minutes per image) and refocus (3 minutes), which included both kinesthetic imagery (KI) and visual imagery (VI). | Behavioural | Motor imagery-based exercise protocol (MIEP) |
| Combination GroupSubjects received 6 sessions of Pain neuroscience education (PNE) and 12 weeks (2 times a week) of Motor imagery-based exercise protocol (MIEP). | Behavioural | Combination Group |
Primary outcome
Visual Analogue Scale (VAS)
Time frame: 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.
8 secondary outcomes
Hospital Anxiety and Depression Scale (HADS)
Time frame: 12 weeks
The Motion Imagery Questionnaire-3 (HLFS-3)
Time frame: 12 weeks
The Pain Beliefs Questionnaire (PBQ)
Time frame: 12 weeks
The Pain Catastrophizing Scale (PCS)
Time frame: 12 weeks
The Tampa Scale for Kinesiophobia (TSK)
Time frame: 12 weeks
Adapting the Scale of Cognitive Emotion Regulation Strategies
Time frame: 12 weeks
Rosenberg Self-esteem Scale
Time frame: 12 weeks
The Body Awareness Questionnaire
Time frame: 12 weeks
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 6 Jun 2023.
Related trials for Fibromyalgia
Active, not recruiting
Objective Measurement of Pain Regulation in Individuals Who Have Received Internet-delivered Exposure-based Cognitive Behavior Therapy
Fibromyalgia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Recruiting
Exercise Interventions and Dietary Advice in Fibromyalgia and IBS
Fibromyalgia, Irritable Bowel Syndrome
Recruiting
Whole-body Cryotherapy in Those With Chronic Fatigue: A Feasibility Study
ME/CFS, Fibromyalgia (FM)
Recruiting
Auricular Acupuncture for Autonomic Balance and Pain in Fibromyalgia
Fibromyalgia Syndrome
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.
Selin Kırcali, Msc study director
Üsküdar 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 Pain neuroscience education (PNE), Motor imagery-based exercise protocol (MIEP) and Combination Group in people with Fibromyalgia and Pain, run by Uskudar 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 6 inclusion and 7 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 6 Jun 2023. 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?
Visual Analogue Scale (VAS) (time frame: 12 weeks). 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 6 Jun 2023.