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

NCT ID: NCT05890326

Last Updated: 2023-06-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-11-20
• Study Completion Date: 2023-05-02

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.

Conditions

Fibromyalgia; Pain; Psychology Regression

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Control group

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Motor imagery-based exercise protocol (MIEP)

Motor imagery-based exercise protocol (MIEP) applied in this group.

Group Type: EXPERIMENTAL

Motor imagery-based exercise protocol (MIEP)

Intervention Type: BEHAVIORAL

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).

Pain neuroscience education (PNE)

Pain neuroscience education (PNE) applied in this group.

Group Type: EXPERIMENTAL

Pain neuroscience education (PNE)

Intervention Type: BEHAVIORAL

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.

Combination Group

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

Group Type: ACTIVE_COMPARATOR

Combination Group

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

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).

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Uskudar University

OTHER

Sponsor Role: lead

Responsible Party

Mesut Karahan

Assoc. Prof.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Selin Kırcali, Msc

Role: STUDY_DIRECTOR

Üsküdar University

Locations

Uskudar University

Istanbul, , Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

fibromyalgiaUSK

Identifier Type: -

Identifier Source: org_study_id