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Not yet recruiting NCT07528599

Virtual Reality-based Motor Imagery in Patients With Fibromyalgia

No phase Interventional Fibromyalgia Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: conventional exercise + motor imagery without virtual reality, conventional exercise + motor imagery with virtual reality.
Who it may be relevant to
Registry conditions: Fibromyalgia Patients. Basic parameters: 18 years — 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Turkey (Türkiye)
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

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.

Interventions

  • 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
  • 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 v

Primary outcome measures

  • pain assessment [Time frame: baseline]
  • pain assessment [Time frame: 6 weeks]
Secondary outcome measures (12)
  • Pressure Pain Threshold Assessment [Time frame: Baseline]
  • Pressure pain threshold assessment [Time frame: 6 weeks]
  • Galvanic Skin Response [Time frame: Baseline]
  • Galvanic Skin Response [Time frame: 6 weeks]
  • Central Sensitivity Inventory [Time frame: Baseline]
  • Central Sensitivity Inventory [Time frame: 6 weeks]
  • Pain Catastrophising Scale [Time frame: Baseline]
  • Pain Catastrophising Scale [Time frame: 6 weeks]
  • Revised Fibromyalgia Impact Questionnaire [Time frame: Baseline]
  • Revised Fibromyalgia Impact Questionnaire [Time frame: 6 weeks]
  • Hospital Anxiety and Depression Scale [Time frame: Baseline]
  • Hospital Anxiety and Depression Scale [Time frame: 6 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Treatment

Study locations

Turkey (Türkiye) · 1 center
  • Inonu University — Malatya

Identifiers

NCT: NCT07528599 · 2026/9676

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗