The Effect of Virtual Reality-Based Motor Imagery on Pain, Psychological Status and Quality of Life in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- pain assessment
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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,
排除标准
- •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
研究组 & 干预措施
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.
干预措施: conventional exercise + motor imagery without virtual reality (Other)
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.
干预措施: conventional exercise + motor imagery with virtual reality (Other)
结局指标
主要结局
pain assessment
时间窗: 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.
pain assessment
时间窗: 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.
次要结局
- Pressure Pain Threshold Assessment(Baseline)
- Pressure pain threshold assessment(6 weeks)
- Galvanic Skin Response(Baseline)
- Galvanic Skin Response(6 weeks)
- Central Sensitivity Inventory(Baseline)
- Central Sensitivity Inventory(6 weeks)
- Pain Catastrophising Scale(Baseline)
- Pain Catastrophising Scale(6 weeks)
- Revised Fibromyalgia Impact Questionnaire(Baseline)
- Revised Fibromyalgia Impact Questionnaire(6 weeks)
- Hospital Anxiety and Depression Scale(Baseline)
- Hospital Anxiety and Depression Scale(6 weeks)
- Pittsburgh Sleep Quality Index(Baseline)
- Pittsburgh Sleep Quality Index(6 weeks)
- Fatigue Severity Scale(Baseline)
- Fatigue Severity Scale(6 weeks)
- Patient's General Perception of Change Scale(Baseline)
- Patient's General Perception of Change Scale(6 weeks)
- Kinesthetic and Visual Imagery Questionnaire(Baseline)
- Kinesthetic and Visual Imagery Questionnaire(6 weeks)
研究者
BÜŞRA CANDİRİ
Assistant Professor
Inonu University