Virtual Reality-based Motor Imagery in Patients With Fibromyalgia

The Effect of Virtual Reality-Based Motor Imagery on Pain, Psychological Status and Quality of Life in Fibromyalgia Patients

This study investigated the effects of a virtual reality-based motor imagery intervention integrated into a conventional exercise programme on pain outcomes (pain intensity, central sensitisation, pressure pain threshold, galvanic skin response, pain catastrophising), quality of life, sleep quality, fatigue, psychological outcomes (Hospital Anxiety and Depression Scale), imagery ability and patient satisfaction.

Study Overview

• Status: Not yet recruiting
• Conditions: Fibromyalgia Patients
• Intervention / Treatment: Other: conventional exercise + motor imagery without virtual reality; Other: conventional exercise + motor imagery with virtual reality

Detailed Description

The study will include individuals aged 18-60 who have been diagnosed with fibromyalgia. Participants will be randomly assigned to one of two groups using a sealed-envelope method: the traditional exercise + virtual reality-assisted motor imagery group, or the traditional exercise + non-virtual reality motor imagery group. In both groups, participants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. In the experimental group, three virtual reality games targeting the upper extremities, trunk and lower extremities will be shown for three minutes each, followed by two minutes of motor imagery. In the control group, the same protocol will be carried out via a monitor without virtual reality. All assessments will be conducted before treatment and at the end of 6 weeks. Pain intensity, Visual Analogue Scale; central sensitivity, Central Sensitivity Inventory; pain catastrophising, Pain Catastrophising Scale; general quality of life, Fibromyalgia Impact Questionnaire; pressure pain threshold, algometer; sleep quality, Pittsburgh Sleep Quality Index; fatigue severity, Fatigue Severity Scale; psychological state, Hospital Anxiety and Depression Scale; patient satisfaction, Patient's General Impression of Change Scale; and imagery ability, Kinesthetic and Visual Imagery Questionnaire-10.

• Study Type: Interventional
• Enrollment (Estimated): 28
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Büşra CANDİRİ; Phone Number: +905073780717; Email: candiri_17@hotmail.com
• Study Contact Backup: Name: İrem YİĞİT; Phone Number: +905375427930; Email: iremmyigitt@outlook.com

Study Locations

• Turkey (Türkiye)
  • Malatya, Turkey (Türkiye)
    • Inonu University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• To be a volunteer,
• To have been diagnosed with fibromyalgia according to the 2016 ACR diagnostic criteria,
• To be aged between 18 and 60,
• To have had pain symptoms for at least 3 months,
• To be receiving standard medical treatment,

Exclusion Criteria:

• The presence of neurological or orthopaedic conditions that would prevent participation in the rehabilitation programme
• Pregnancy,
• The presence of cognitive impairments that could affect cooperation,
• The presence of serious, uncontrolled health problems,
• A history of lower limb or spinal surgery
• Visual or hearing impairments;
• Serious psychiatric disorders
• A diagnosis of migraine
• Regular physical exercise in the last three months (≥2 days per week)
• Participation in any concurrent physiotherapy or rehabilitation intervention

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: conventional exercise + motor imagery without virtual reality; Participants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. Three virtual reality games targeting the upper limbs, trunk and lower limbs will be used; participants will watch these games on a monitor and visualise the movements.	Other: conventional exercise + motor imagery without virtual reality; Participants in the control groups will undergo a structured conventional exercise programme under the supervision of a physiotherapist, three days a week for six weeks. The conventional exercise programme has been designed to include stretching, postural control and muscle strengthening components. Each session will last approximately 30 minutes. The intensity and difficulty level of the exercises will be gradually increased every two weeks and progressed in a controlled manner. In the control group, recorded versions of virtual reality games will be presented via a standard monitor screen without the use of a virtual reality headset. Participants will watch each video for three minutes and will then be asked to visualise the same movements for two minutes. The total duration of the motor imagery intervention in the control group will also be 15 minutes.; Other Names: control group
Experimental: conventional exercise + motor imagery with virtual reality; Participants will undergo a traditional rehabilitation programme three days a week under the supervision of a physiotherapist. Participants will watch three virtual reality games, each lasting three minutes and targeting the upper limbs, trunk and lower limbs, and will then perform motor imagery for two minutes.	Other: conventional exercise + motor imagery with virtual reality; A structured conventional exercise programme will be implemented three days a week for six weeks. The conventional exercise programme has been designed to include components of stretching, postural control and muscle strengthening. Each session will last approximately 30 minutes. The intensity and difficulty level of the exercises will be gradually increased every two weeks and progressed in a controlled manner. In the experimental group, motor imagery exercises will be performed by creating a virtual environment using the provided virtual reality headset. In this group, a total of three different virtual reality games targeting the upper limbs, trunk and lower limbs will be used. Each game will be viewed for three minutes via the virtual reality headset, after which participants will be asked to mentally visualise the relevant movements for two minutes. The total duration of the motor imagery intervention is planned to be 15 minutes.; Other Names: experimental group

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain assessment	Pain during rest and activity will be assessed using the VAS. The VAS is a 10-cm scale where 0 points indicate 'no pain' and 10 points indicate 'the worst pain imaginable'. Participants will be asked to mark the scale based on their assessment of pain intensity over the past 24 hours. Pain intensity will be measured using the scale and recorded in centimetres.	baseline
pain assessment	Pain during rest and activity will be assessed using the VAS. The VAS is a 10-cm scale where 0 points indicate 'no pain' and 10 points indicate 'the worst pain imaginable'. Participants will be asked to mark the scale based on their assessment of pain intensity over the past 24 hours. Pain intensity will be measured using the scale and recorded in centimetres.	6 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pressure Pain Threshold Assessment	An algometer will be used to assess the pressure pain threshold. During the assessment, tender points at the occipital base, lower cervical region, trapezius, supraspinatus, second costochondral joint, lateral epicondyle and medial knee border will be measured bilaterally. In addition, the patient will be asked to stand upright so that the tender points of the gluteus and greater trochanter can also be assessed. Each measurement will be repeated three times bilaterally, and the average of the values obtained will be recorded.	Baseline
Pressure pain threshold assessment	An algometer will be used to assess the pressure pain threshold. During the assessment, tender points at the occipital base, lower cervical region, trapezius, supraspinatus, second costochondral joint, lateral epicondyle and medial knee border will be measured bilaterally. In addition, the patient will be asked to stand upright so that the tender points of the gluteus and greater trochanter can also be assessed. Each measurement will be repeated three times bilaterally, and the average of the values obtained will be recorded.	6 weeks
Galvanic Skin Response	Galvanic skin response is an important physiological parameter that measures changes in the electrical conductivity of the skin surface and reflects sympathetic nervous system activity. It is frequently used as a non-invasive, reliable and sensitive method for assessing autonomic nervous system responses. In this study, galvanic skin response measurements will be carried out using a galvanic skin response sensor to be acquired as part of the project, with the aim of objectively evaluating the effects of a virtual reality-based motor imagery intervention on autonomic physiological responses. The galvanic skin response will be recorded.	Baseline
Galvanic Skin Response	Galvanic skin response is an important physiological parameter that measures changes in the electrical conductivity of the skin surface and reflects sympathetic nervous system activity. It is frequently used as a non-invasive, reliable and sensitive method for assessing autonomic nervous system responses. In this study, galvanic skin response measurements will be carried out using a galvanic skin response sensor to be acquired as part of the project, with the aim of objectively evaluating the effects of a virtual reality-based motor imagery intervention on autonomic physiological responses. The galvanic skin response will be recorded .	6 weeks
Central Sensitivity Inventory	The Central Sensitivity Inventory is a patient-completed questionnaire used to assess the severity of central sensitivity symptoms associated with chronic pain. The questionnaire consists of 9 items, each of which examines pain and associated symptoms originating from the central nervous system. High scores on the scale indicate that symptoms of central sensitisation are more pronounced and severe; low scores, on the other hand, indicate a milder level of central sensitisation.	Baseline
Central Sensitivity Inventory	The Central Sensitivity Inventory is a patient-completed questionnaire used to assess the severity of central sensitivity symptoms associated with chronic pain. The questionnaire consists of 9 items, each of which examines pain and associated symptoms originating from the central nervous system. High scores on the scale indicate that symptoms of central sensitisation are more pronounced and severe; low scores, on the other hand, indicate a milder level of central sensitisation.	6 weeks
Pain Catastrophising Scale	A 13-item self-report instrument that assesses individuals' catastrophising regarding pain, i.e. their negative cognitive and emotional responses. The scale covers the dimensions of pain exaggeration, feelings of helplessness and persistent negative thoughts. A high score is associated with an intensified perception of pain in patients with chronic pain .	Baseline
Pain Catastrophising Scale	A 13-item self-report instrument that assesses individuals' catastrophising regarding pain, i.e. their negative cognitive and emotional responses. The scale covers the dimensions of pain exaggeration, feelings of helplessness and persistent negative thoughts. A high score is associated with an intensified perception of pain in patients with chronic pain	6 weeks
Revised Fibromyalgia Impact Questionnaire	The Revised Fibromyalgia Impact Questionnaire is used to assess the overall impact of fibromyalgia on a patient's daily life, functional status and symptom burden. It is a reliable and valid tool for monitoring disease severity and response to treatment in both clinical practice and research. The scale consists of three sub-sections: functional status, overall impact and symptoms, and contains a total of 21 items. Items are scored on a scale of 0-10, and the sub-sections are adjusted using specific weightings to produce an overall score out of 100. A higher score is associated with a more severe clinical presentation and a lower quality of life.	Baseline
Revised Fibromyalgia Impact Questionnaire	The Revised Fibromyalgia Impact Questionnaire is used to assess the overall impact of fibromyalgia on a patient's daily life, functional status and symptom burden. It is a reliable and valid tool for monitoring disease severity and response to treatment in both clinical practice and research. The scale consists of three sub-sections: functional status, overall impact and symptoms, and contains a total of 21 items. Items are scored on a scale of 0-10, and the sub-sections are adjusted using specific weightings to produce an overall score out of 100. A higher score is associated with a more severe clinical presentation and a lower quality of life.	6 weeks
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale is used to measure patients' levels of anxiety and depression. It is a self-report scale comprising a total of 14 items. Seven items assess anxiety levels, whilst the other seven assess depression levels. Each item is scored on a scale of 0 to 3 using a 4-point Likert-type scale. The cut-off value is set at 10 for anxiety and 7 for depression.	Baseline
Hospital Anxiety and Depression Scale	The Hospital Anxiety and Depression Scale is used to measure patients' levels of anxiety and depression. It is a self-report scale comprising a total of 14 items. Seven items assess anxiety levels, whilst the other seven assess depression levels. Each item is scored on a scale of 0 to 3 using a 4-point Likert-type scale. The cut-off value is set at 10 for anxiety and 7 for depression.	6 weeks
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index will be used to assess sleep quality over the past month. It consists of a total of 24 questions, 18 of which are answered by the individual, and the assessment is based on seven components: subjective sleep quality, time taken to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime functional impairment. Each item is scored on a scale of 0-3, and the sum of the component scores forms the overall sleep quality score. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.	Baseline
Pittsburgh Sleep Quality Index	The Pittsburgh Sleep Quality Index will be used to assess sleep quality over the past month. It consists of a total of 24 questions, 18 of which are answered by the individual, and the assessment is based on seven components: subjective sleep quality, time taken to fall asleep, sleep duration, habitual sleep efficiency, sleep disturbances, use of sleep medication, and daytime functional impairment. Each item is scored on a scale of 0-3, and the sum of the component scores forms the overall sleep quality score. The total score ranges from 0 to 21, with higher scores indicating poorer sleep quality.	6 weeks
Fatigue Severity Scale	The Fatigue Severity Scale assesses individuals' levels of fatigue over the past month. It is a 9-item self-report instrument. Each item is scored on a scale of 1 to 7, with higher scores indicating greater fatigue severity .	Baseline
Fatigue Severity Scale	The Fatigue Severity Scale assesses individuals' levels of fatigue over the past month. It is a 9-item self-report instrument. Each item is scored on a scale of 1 to 7, with higher scores indicating greater fatigue severity.	6 weeks
Patient's General Perception of Change Scale	Following completion of the exercise programme, patients will be asked to assess changes in their symptoms before and after treatment. The 7-point Likert-scale PGPCS will be used to subjectively measure patients' response to treatment. The scale allows patients to rate changes in their general health status as follows: 1) improved considerably, 2) improved a lot, 3) improved slightly, 4) no change, 5) slightly worse, 6) worse, 7) much worse. It is widely used in clinical trials and routine practice to assess patients' response to treatment quickly and effectively.	Baseline
Patient's General Perception of Change Scale	Following completion of the exercise programme, patients will be asked to assess changes in their symptoms before and after treatment. The 7-point Likert-scale PGPCS will be used to subjectively measure patients' response to treatment. The scale allows patients to rate changes in their general health status as follows: 1) improved considerably, 2) improved a lot, 3) improved slightly, 4) no change, 5) slightly worse, 6) worse, 7) much worse. It is widely used in clinical trials and routine practice to assess patients' response to treatment quickly and effectively.	6 weeks
Kinesthetic and Visual Imagery Questionnaire	The Kinesthetic and Visual Imagery Questionnaire aims to determine the extent to which individuals can visualise and kinesthetically perceive the movements they imagine. All items are administered whilst the participant is seated and consist of two subscales: visual imagery and kinesthetic imagery. In the Kinesthetic and Visual Imagery Questionnaire, each item is scored on a scale of 1-5 (1 = no sensation/image, 5 = as intense as if performing the movement/as clear as the real thing), with the total score ranging from 10 to 50; higher scores indicate better imagery ability.	Baseline
Kinesthetic and Visual Imagery Questionnaire	The Kinesthetic and Visual Imagery Questionnaire aims to determine the extent to which individuals can visualise and kinesthetically perceive the movements they imagine. All items are administered whilst the participant is seated and consist of two subscales: visual imagery and kinesthetic imagery. In the Kinesthetic and Visual Imagery Questionnaire, each item is scored on a scale of 1-5 (1 = no sensation/image, 5 = as intense as if performing the movement/as clear as the real thing), with the total score ranging from 10 to 50; higher scores indicate better imagery ability.	6 weeks

Collaborators and Investigators

• Sponsor: Inonu University

Study record dates

Study Major Dates

• Study Start (Estimated): March 25, 2026
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: April 7, 2026
• First Submitted That Met QC Criteria: April 7, 2026
• First Posted (Actual): April 14, 2026

Study Record Updates

• Last Update Posted (Actual): April 14, 2026
• Last Update Submitted That Met QC Criteria: April 7, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Keywords: exercise; rehabilitation; virtual reality; Fibromyalgia; motor imagery
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Nervous System Diseases; Muscular Diseases; Neuromuscular Diseases; Rheumatic Diseases; Behavior; Fibromyalgia; Motor Activity; Investigative Techniques; Epidemiologic Research Design; Epidemiologic Methods; Research Design; Methods; Control Groups
• Other Study ID Numbers: 2026/9676

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No