DTx for Pain: Behavioural Revalidation in Augmented and Virtual Reality for Chronic Pain; and Exploratory Pilot Study of a Virtual Reality Software
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Pain Behaviour, pain intensity
研究概览
简要总结
Prospective, randomised, double-blind, 3-arm parallel group comparison of 2 different virtual reality softwares and standard care.
详细描述
Prospective, randomised, double-blind, 3-arm parallel group comparison of DTx for pain (treatment A), control (treatment B) and an open standard care arm, over 6-8 weeks. An optional adaptive, multi-objective, multi-purpose, extension is included. Study devices will be delivered to the patient's home with instructions for use; patients will receive remote technical support.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Competent male or female adults (age ≥ 18 years).
- •Chronic low back pain
- •Written informed consent
- •Finnish speaking
- •having a clear, flat surface of at least 2 x 2 m of size to interact with DTx for pain
- •Can stoop without severe pain
排除标准
- •History of epilepsy, migraine, vertigo or psychosis
- •Confirmed diagnosis of cancer
- •Prone to strong motion sickness requiring treatment
- •Pregnancy
- •Physiotherapy based interventions contraindicated
- •Severe or acute structural pathologies (e.g. spondylitis, epidural abscess, spondylolisthesis, acute herniated or ruptured disc, traumatic injury, or severe spinal stenosis) that could be worsened by the intervention as assessed by the principal investigator
- •Has received (in last 2 years) or is receiving formal psychotherapy from a psychologist for pain or allied health care professional at the screening stage
- •Any other condition that would affect posture or balance, and
- •Prior participation in DTx for pain feasibility study or in any part of the current study
结局指标
主要结局
Pain Behaviour, pain intensity
时间窗: From randomisation upto 6-8 weeks
Numerical Rating Scale, PROMIS 3a - Pain Intensity Scale, score 3-15 (3=no pain,15=very severe pain).
Quality of life, change
时间窗: From randomisation upto 6-8 weeks
Patient Clinical Global Impression of Change (PGIC) results, score 1-7 (1=very much improved, 7=very much worse).
Pain Behaviour, pain medications
时间窗: From randomisation upto 6-8 weeks
Any changes in pain medication during the study period are reported as outcome.
Self-report of disability; Pain Interference
时间窗: From randomisation upto 6-8 weeks
The Patient Reported Outcomes Information System (PROMIS) 6b - Pain Interference Scale, score 6-30 (6=pain not at all interfering patient's life, 30=maximum interfering to patient's life).
Objective report of disability, steps
时间窗: From randomisation upto 6-8 weeks
Average number of steps per day over one week, as assessed by wearable equipment, 0-maximum amount of steps (0=patient not taking steps at all, maximum disability; maximum number of steps=minimum disability).
Fear of movement and re-injury
时间窗: From randomisation upto 6-8 weeks
Tampa Scale of Kinesiophobia (TSK), score 17-68 (17=negligible or no kinesiophobia,68=extreme fear of pain with movement).
Quality of life, own experience
时间窗: From randomisation upto 6-8 weeks
EuroQol-5D-5L-scale: European Quality (EQ) of Life (l), 5-dimension-5-level-scale. a). Descriptive System, 5-dimension-5-level-scale, scores are converted to a value where 1 equals 'perfect health' and 0 equals 'dead'. b). Visual Analogue Score, score 0 to 100 where 100 is the best health you can imagine and 0 = the worst health you can imagine.
Quality of life, adverse events
时间窗: From randomisation upto 6-8 weeks
Adverse Event reporting, number of adverse events and their severity
Self-report of disability, Oswestry
时间窗: From randomisation upto 6-8 weeks
Oswestry Disability Index (subjects with a score of ≤22 will be considered as responders), index 0%-100% (0=no disability, 100=maximum disability possible).
次要结局
未报告次要终点