A Pilot Study on the Efficacy, Acceptability, Tolerability and Feasibility of a Therapeutic Virtual Reality Application on Improving the Quality of Life in Non-specific Chronic Low-back Pain Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 41
- 试验地点
- 2
- 主要终点
- Change in SF12: short form health survey
研究概览
简要总结
This study evaluates the effect of therapeutic Virtual Reality (VR) on quality of life of 60 patients with non-specific chronic low-back pain. 30 patients will be included in the intervention group. These patients will use Reducept, a therapeutic virtual reality application based on diverse cognitive therapies (ACT, mindfulness, EMDR, hypnotherapy), at home over a period of 28 days, for at least 10 minutes each day. This will be an add-on intervention next to standard care, while the patient is waiting to receive actual treatment for chronic pain. 30 patients in the control group will only receive standard care, whilst waiting to receive actual treatment for their chronic pain. Intervention and control group will be compared on a number of outcome measures related to quality of life before using VR, during VR use, just after use and 4 months after final use. This explorative study is necessary to get first insights as a basis for a confirmative study.
详细描述
Rationale:
21,2% of the Dutch population is suffering from chronic low-back pain. 90% of these patients suffers from chronic low-back pain not attributable to a recognisable, specific pathology (non-specific low-back pain). 30-40% of all patients suffering from chronic pain visit their GP for treatment. Treatment includes mostly analgesics, in particular NSAIDs and opioids.
Adequate treatment of chronic pain is important as chronic pain negatively impacts, amongst others, quality of life, activities of daily living and feelings of helplessness. A systematic review by Bala et al. however shows that chronic pain treatment is often inadequate. Moreover, each different type of analgesic has its own associated side effects. NSAIDs increase the risk of cardiovascular and gastrointestinal complications. Common side effects of opioid analgesics include sedation, dizziness, nausea, vomiting, constipation, physical dependence, and even cases of hyperalgesia.
Recently, more attention has been given to psychological interventions for relieving chronic pain. A systematic review by Castelnuovo et al. shows the efficacy of a range of psychological interventions, including acceptance and commitment therapy (ACT), mindfulness-based interventions, hypnotherapy, eye movement and desensitization and reprocessing (EMDR) therapies and virtual reality based interventions. All of these psychological interventions focus on changing people's attitudes, feelings and behaviors on chronic pain, to improve their quality of life.
The first psychological intervention is the commonly used acceptance and commitment therapy (ACT). ACT is a cognitive behavioral therapy for treating chronic pain that uses exposure-based and experiential methods aiming at improving patients' abilities to cope with their chronic pain. Several systematic reviews indicate that ACT is effective in improving health outcomes of chronic pain patients. Mindfulness-based interventions seem to work as well for chronic pain relief. This set of interventions aims at learning strategies for pain awareness and acceptance. Furthermore, hypnotherapy is a mind-body based intervention that uses hypnoses to learn patients to cope with their pain. It focuses attention away from pain, thereby blocking its experience. Hypnotherapy seems effective in reducing pain experience. Then, eye movement desensitization and reprocessing (EMDR) is another psychotherapeutic approach in treating chronic pain. EMDR has already shown to be effective in treating posttraumatic stress disorder, and has recently as well been introduced as a treatment for chronic pain. Early research findings indicate EMDR to be effective in treating chronic pain.
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 110 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patient suffers from chronic non-specific low-back pain (LBP) not attributable to a recognisable, known specific pathology (e.g. infection, tumour, osteoporosis, lumbar spine fracture, structural deformity, inflammatory disorder, radicular syndrome, or cauda equina syndrome).
- •Patient reports a pain score related to chronic low-back pain ≥
- •Patient is placed on the waiting list to receive intervention and receives no treatment yet, apart from medication or physiotherapy.
- •At the day of recruitment, the estimated length of the waiting list for intervention is at least six weeks.
- •Patient did not receive any invasive treatment for his chronic non-specific low-back pain in the last year.
- •Patient is willing and able to comply with the trial protocol.
- •Patient is at least 18 years old on the day the oral informed consent will be given.
- •Patient can read and understand the Dutch language.
排除标准
- •Patient is included in another trial to evaluate new ways of treating pain.
- •Patients suffers from severe anxiety or depression (HADS≥16).
- •Patient has difficulties to handle virtual reality:
- •Patient suffers from delirium or acute confusional state.
- •Patient has (a history of) dementia, seizure, or epilepsy.
- •Patient has severe hearing/visual impairment not corrected.
- •The skin of the patient's head or face is not intact (for example head wounds, psoriasis, eczema).
结局指标
主要结局
Change in SF12: short form health survey
时间窗: Day 0, day 28, day 148
Measurement of changes in quality of life of patient before intervention, just after intervention period and 4 months after intervention period. SF12 measures via different scaled questions eight concepts: physical functioning, role limitations due to physical health problems, bodily pain, general health, vitality, social functioning, role limitations due to emotional problems, and mental health. The first four items together form the physical health scale. The latter four items form the mental health scale. The higher the scores, the better the physical and mental health. Highest possible score: 56. Lowest possible score: 12.
次要结局
- Change in pain via numeric rating score(Day 0, day 28, day 148)
- Change in PCS: Pain Catastrophizing Scale(Day 0, day 28, day 148)
- Change in OLBPDQ: Oswestry Low Back Pain Disability Questionnaire(Day 0, day 28, day 148)
- Change in positive health questionnaire(Day 0, day 28, day 148)
- Change in PCCL: Pain Coping and Cognition list(Day 0, day 28, day 148)
- Change in BPI: brief pain inventory, numeric rating score(Day 0, day 28, day 148)
- Change in HADS: Hospital Anxiety and Depression Scale(Day 0, day 28, day 148)
- Change in ADL: Activities of Daily Life(Day 0, day 28, day 148)
- Change in pain questionnaire via numeric pain rating scale(Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days)
- Medication use questionnaire(Questionnaires will be filled in at the end of each intervention day during the intervention period of 28 days)