TITAN: a Randomised Controlled Trial Investigating the Effectiveness of Two Treatment Programs for Reducing Phantom Limb Pain Intensity and Its Interference with Function
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 208
- 试验地点
- 2
- 主要终点
- Pain interference
研究概览
简要总结
The goal of this clinical trial is to investigate the effectiveness of two rehabilitation programs for individuals who have undergone amputations and are experiencing phantom limb pain. The main question it aims to answer is:
- In individuals who have undergone amputations and are experiencing phantom limb pain, what is the effectiveness of a progressive rehabilitation program compared to a treatment program consisting of transcutaneous electrical nerve stimulation and cranial electrical stimulation on reducing pain intensity and pain interference?
A total of 208 participants will be randomized into two groups: progressive rehabilitation program and stimulation devices. The progressive rehabilitation program includes pain science education, sensory training, and left/right judgements, imagined movements and mirror therapy. The treatment program for the group receiving the stimulation devices includes transcutaneous electrical nerve stimulation and cranial electrical stimulation. Both interventions will be delivered via eight, up to 1-hour telehealth sessions. Outcome measures will be assessed at baseline and weeks 12, 24 and 52.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Experiencing phantom limb pain for at least three months.
- •Report at least one episode of phantom limb pain in the previous week.
- •Report at least 4 points in pain intensity over the previous 7 days, assessed using the 11-point Numerical Pain Rating Scale.
- •Be a resident in Australia for the intervention and follow-up period.
- •Have access to the internet and smart device (e.g., mobile phone).
- •Be proficient in English.
排除标准
- •Bilateral amputation.
- •Scheduled for major surgery during the study period.
- •Pain in the intact limb.
- •Vision impairment that would preclude successful participation.
- •Auditory impairment that would preclude successful participation.
- •Cognitive problems that would preclude effective participation in trial procedures (e.g., Alzheimer's, dementia).
- •Previously diagnosed neurological disorders that affect the movement of the intact limb (e.g., stroke, Parkinson, Multiple Sclerosis).
- •Completed Graded Motor Imagery in the order of left/right judgements, imagined movements, and mirror therapy.
- •Have contraindications for the use of stimulation devices (e.g., pacemaker, spinal cord stimulator).
结局指标
主要结局
Pain interference
时间窗: Week 12 post-randomisation
Average pain interference with function over the previous 7 days assessed using the 0-10 Pain Interference Scale of the Brief Pain Inventory.
Pain intensity
时间窗: Week 12 post-randomisation
Average pain intensity over the previous 7 days assessed using the 11-point Numerical Pain Rating Scale.
次要结局
- Pain interference(Weeks 24 and 52 post-randomisation)
- EuroQol 5-Dimension 5-Level (EQ-5D-5L)(Weeks 12, 24 and 52 post-randomisation)
- Pain intensity(Weeks 24 and 52 post-randomisation)
- Pain severity(Weeks 12, 24 and 52 post-randomisation)
- Sleep subscale of the Brief Pain Inventory's Pain Interference Scale(Weeks 12, 24 and 52 post-randomisation)
- PROMIS Self-Efficacy Manage Symptoms(Weeks 12, 24 and 52 post-randomisation)
- PROMIS Depression(Weeks 12, 24 and 52 post-randomisation)
- Adherence to treatment(From randomisation to week 12 post-randomisation)
- Global Perceived Effect Scale(Weeks 12, 24 and 52 post-randomisation)
- Adverse events(From randomisation to week 12 post-randomisation)
- Total health-care costs(Weeks 12, 24 and 52 post-randomisation)
- Treatment rationale credibility(Week 1 post-randomisation)
研究者
James McAuley
Principal Investigator
Neuroscience Research Australia