Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07528599

Virtual Reality-based Motor Imagery in Patients With Fibromyalgia

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Inonu University

Malatya, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

conventional exercise + motor imagery without virtual reality

Other

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

conventional exercise + motor imagery with virtual reality

Other

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

Primary outcomes

  1. pain assessment

    Time frame: baseline

    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.

  2. pain assessment

    Time frame: 6 weeks

    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.

Secondary outcomes

  1. Pressure Pain Threshold Assessment

    Time frame: Baseline

    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.

  2. Pressure pain threshold assessment

    Time frame: 6 weeks

    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.

  3. Galvanic Skin Response

    Time frame: Baseline

    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.

  4. Galvanic Skin Response

    Time frame: 6 weeks

    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 .

  5. Central Sensitivity Inventory

    Time frame: Baseline

    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. Central Sensitivity Inventory

    Time frame: 6 weeks

    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.

  7. Pain Catastrophising Scale

    Time frame: Baseline

    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 .

  8. Pain Catastrophising Scale

    Time frame: 6 weeks

    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

  9. Revised Fibromyalgia Impact Questionnaire

    Time frame: Baseline

    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.

  10. Revised Fibromyalgia Impact Questionnaire

    Time frame: 6 weeks

    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.

  11. Hospital Anxiety and Depression Scale

    Time frame: Baseline

    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.

  12. Hospital Anxiety and Depression Scale

    Time frame: 6 weeks

    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.

  13. Pittsburgh Sleep Quality Index

    Time frame: Baseline

    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.

  14. Pittsburgh Sleep Quality Index

    Time frame: 6 weeks

    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.

  15. Fatigue Severity Scale

    Time frame: Baseline

    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 .

  16. Fatigue Severity Scale

    Time frame: 6 weeks

    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.

  17. Patient's General Perception of Change Scale

    Time frame: Baseline

    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.

  18. Patient's General Perception of Change Scale

    Time frame: 6 weeks

    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.

  19. Kinesthetic and Visual Imagery Questionnaire

    Time frame: Baseline

    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.

  20. Kinesthetic and Visual Imagery Questionnaire

    Time frame: 6 weeks

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Büşra CANDİRİ

CONTACT

[email protected]

+905073780717

İrem YİĞİT

CONTACT

[email protected]

+905375427930

Sponsors and collaborators

Lead sponsor

Inonu University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Apr 14, 2026
Registry last updated
Apr 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.