search
Back to results

Pain Neuroscience Education and Motor Imagery-based Exercise Protocol for Patients With Fibromyalgia

Primary Purpose

Fibromyalgia, Pain, Psychology Regression

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Pain neuroscience education (PNE)
Motor imagery-based exercise protocol (MIEP)
Combination Group
Sponsored by
Uskudar University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Fibromyalgia

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Uskudar University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Experimental

Experimental

Active Comparator

Arm Label

Control group

Motor imagery-based exercise protocol (MIEP)

Pain neuroscience education (PNE)

Combination Group

Arm Description

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) applied in this group.

Pain neuroscience education (PNE) applied in this group.

Both Pain neuroscience education (PNE) and Motor imagery-based exercise protocol (MIEP) applied in this group.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)
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.
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.
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.
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.
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.
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.
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.

Full Information

First Posted
May 16, 2023
Last Updated
May 25, 2023
Sponsor
Uskudar University
search

1. Study Identification

Unique Protocol Identification Number
NCT05890326
Brief Title
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

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Completed
Study Start Date
November 20, 2022 (Actual)
Primary Completion Date
January 14, 2023 (Actual)
Study Completion Date
May 2, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Uskudar University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Fibromyalgia, Pain, Psychology Regression

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control group
Arm Type
No Intervention
Arm Description
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.
Arm Title
Motor imagery-based exercise protocol (MIEP)
Arm Type
Experimental
Arm Description
Motor imagery-based exercise protocol (MIEP) applied in this group.
Arm Title
Pain neuroscience education (PNE)
Arm Type
Experimental
Arm Description
Pain neuroscience education (PNE) applied in this group.
Arm Title
Combination Group
Arm Type
Active Comparator
Arm Description
Both Pain neuroscience education (PNE) and Motor imagery-based exercise protocol (MIEP) applied in this group.
Intervention Type
Behavioral
Intervention Name(s)
Pain neuroscience education (PNE)
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Motor imagery-based exercise protocol (MIEP)
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Combination Group
Intervention Description
Subjects received 6 sessions of Pain neuroscience education (PNE) and 12 weeks (2 times a week) of Motor imagery-based exercise protocol (MIEP).
Primary Outcome Measure Information:
Title
Visual Analogue Scale (VAS)
Description
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.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Hospital Anxiety and Depression Scale (HADS)
Description
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)
Time Frame
12 weeks
Title
The Motion Imagery Questionnaire-3 (HLFS-3)
Description
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.
Time Frame
12 weeks
Title
The Pain Beliefs Questionnaire (PBQ)
Description
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.
Time Frame
12 weeks
Title
The Pain Catastrophizing Scale (PCS)
Description
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.
Time Frame
12 weeks
Title
The Tampa Scale for Kinesiophobia (TSK)
Description
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.
Time Frame
12 weeks
Title
Adapting the Scale of Cognitive Emotion Regulation Strategies
Description
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.
Time Frame
12 weeks
Title
Rosenberg Self-esteem Scale
Description
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.
Time Frame
12 weeks
Title
The Body Awareness Questionnaire
Description
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.
Time Frame
12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Selin Kırcali, Msc
Organizational Affiliation
Üsküdar University
Official's Role
Study Director
Facility Information:
Facility Name
Uskudar University
City
Istanbul
ZIP/Postal Code
34662
Country
Turkey

12. IPD Sharing Statement

Learn more about this trial

Pain Neuroscience Education and Motor Imagery-based Exercise Protocol for Patients With Fibromyalgia

We'll reach out to this number within 24 hrs