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

Pain Clinical Trial

Official title:

Pain Neuroscience Education and Motor Imagery-based Exercise Protocol in Fibromyalgia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05890326
• Other study ID #: fibromyalgiaUSK
• Status: Completed
• Phase: N/A
• Start date: November 20, 2022
• Est. completion date: May 2, 2023

Study information

• Verified date: May 2023
• Source: Uskudar University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 2, 2023
• Est. primary completion date: January 14, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Fibromyalgia
• Myofascial Pain Syndromes
• Pain

Intervention

Behavioral:
• 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.
• 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).
• Combination Group
Subjects received 6 sessions of Pain neuroscience education (PNE) and 12 weeks (2 times a week) of Motor imagery-based exercise protocol (MIEP).

Locations

Country	Name	City	State
Turkey	Uskudar University	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Uskudar University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	12 weeks
Secondary	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)	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks
Secondary	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.	12 weeks