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

NCT05890326 | Completed DMC

• 1 other identifier: fibromyalgiaUSK
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• Hospital Anxiety and Depression Scale (HADS)

  12 weeks

• The Motion Imagery Questionnaire-3 (HLFS-3)

  12 weeks

• The Pain Beliefs Questionnaire (PBQ)

  12 weeks

• The Pain Catastrophizing Scale (PCS)

  12 weeks

• The Tampa Scale for Kinesiophobia (TSK)

  12 weeks

Study Arms (4)

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.

Behavioral: Motor imagery-based exercise protocol (MIEP)

Pain neuroscience education (PNE)

EXPERIMENTAL

Pain neuroscience education (PNE) applied in this group.

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.

Behavioral: Combination Group

Interventions

Pain neuroscience education (PNE) 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.

Pain neuroscience education (PNE)

Motor imagery-based exercise protocol (MIEP) 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).

Motor imagery-based exercise protocol (MIEP)

Combination Group BEHAVIORAL

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

Combination Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Uskudar University: lead

Study Sites (1)

Uskudar University

Istanbul, 34662, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Fibromyalgia; Pain

Condition Hierarchy (Ancestors)

Muscular Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neuromuscular Diseases; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Selin Kırcali, Msc

  Üsküdar University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assoc. Prof.

Study Record Dates

• First Submitted: May 16, 2023
• First Posted: June 6, 2023
• Study Start: November 20, 2022
• Primary Completion: January 14, 2023
• Study Completion: May 2, 2023
• Last Updated: June 6, 2023

Record last verified: 2023-05

Locations

TU (1)