Virtual Reality-based Motor Imagery in Patients With Fibromyalgia

April 7, 2026 updated by: BÜŞRA CANDİRİ, Inonu University

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

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
baseline
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.
6 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline
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.
6 weeks
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.
Baseline
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 .
6 weeks
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.
Baseline
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.
6 weeks
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 .
Baseline
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
6 weeks
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.
Baseline
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.
6 weeks
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.
Baseline
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.
6 weeks
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.
Baseline
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.
6 weeks
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 .
Baseline
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.
6 weeks
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.
Baseline
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.
6 weeks
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.
Baseline
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.
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Inonu University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 25, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 14, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 14, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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