An Investigation of the Efficacy of a Novel Sensory Discrimination Training Device for the Management of Phantom Limb Pain: A Randomised, Single-blind, Placebo-controlled Trial. [PHANTOM RELIEF Trial]
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 109
- 试验地点
- 2
- 主要终点
- The short form McGill Pain Questionnaire (SF-MPQ-2)
研究概览
简要总结
86-87% of people who have had an amputation still feel pain in the limb that has been amputated - Phantom limb pain (PLP). Sensory retraining is a form of treatment for PLP where a special form of electrical stimulation is delivered to the residual limb.
The theory is that this stimulation changes activity in the brain that helps to reduce the person's pain. Two new types of sensory retraining device for the treatment of phantom limb pain have been developed. One type requires the user to interact with the device while the other is a non-interactive device. Both devices are new so it is unknown as to how well they may work, or which is best, therefore both will be tested in this study.
This study will be undertaken remotely, using video call, telephone and email for communication. The study will compare the effect of both devices for efficacy. One hundred people with PLP will be recruited from the NHS and the general public and randomised to receive either the interactive or non-interactive device or their placebo equivalents. A health care professional will train the research participants how to use their device. Participants will then use their device at home for 3 weeks. To ensure that they are using their devices as required, the researchers will keep in contact throughout the three week treatment period, using a schedule of video calls, weekly phone calls and daily texts. Pain and function will be measured before treatment, after treatment and at a 3 month follow-up. Twelve participants will also be invited to a one-to-one interview to give their experience of the acceptability and usability of their device.
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
- Double (Participant, Outcomes Assessor)
盲法说明
The participants and statistician will be blinded to treatment allocation. Outcome measures will be self reported by the participants. The care provider will not be blind, as they are required to provide specific instructions for each group.
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
The short form McGill Pain Questionnaire (SF-MPQ-2)
时间窗: Day 1 (baseline prior to start) and Day 21 (end) of treatment period
The primary outcome will be the total score of the McGill Pain Questionnaire revised (SF-MPQ-2)8 20 at the 3-week time point. The SF-MPQ-2 is a commonly used questionnaire to assess pain levels in a range of pain conditions. There are 22 items/ pain descriptors across 4 pain sub-scales/ domains: continuous, intermittent, neuropathic, and affective. Participants rate each item on an 11-point (0-10) scale, where 0 = none and 10 = worst possible pain. The mean of the 22 items provides the SF-MPQ-2 total score. Two or more missing responses on any sub-scale results in an invalid outcome. A targeted effect size of 1 unit difference between groups will be used.
次要结局
- Participant satisfaction(Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Device Usability(Day 21 (end) of treatment period)
- Study Diary (medication use/device use/pain levels)(Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Concordance with Protocol(Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period)
- Credibility of Devices(At 3 month follow up point post end of treatment)
- EQ5D5L(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Sleep Disturbance(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Overall Pain: Visual Analogue Scale (100mm):(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Frequency adjusted pain score: (0-100)(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- General Subjective Outcome Score (GSOS)(Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- The short form McGill Pain Questionnaire (SF-MPQ-2)(3 month follow up point post end of treatment period)
- Trinity Amputation and prosthetic evaluation scale (modified) (TAPES)(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Overall Pain: Visual Analogue Scale (100mm):(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Frequency adjusted pain score: (0-100)(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- EQ5D5L(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Device Usability(Day 21 (end) of treatment period)
- General Subjective Outcome Score (GSOS)(Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- The short form McGill Pain Questionnaire (SF-MPQ-2)(3 month follow up point post end of treatment period)
- Trinity Amputation and prosthetic evaluation scale (modified) (TAPES)(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Participant satisfaction(Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Sleep Disturbance(Day 1 (baseline prior to start) and Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Study Diary (medication use/device use/pain levels)(Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period and at 3 month follow up point post end of treatment)
- Concordance with Protocol(Each Day Days 1 (baseline prior to start) to Day 21 (end) of treatment period)
- Credibility of Devices(At 3 month follow up point post end of treatment)
研究者
Sarah Oatway
Clinical Trial Manager
Teesside University