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
- 1
- 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
- •Living in the UK
- •All Genders
- •Aged ≥18 years of age
- •Women who self-declare:
- •that they are post-menopausal, or permanently sterile*,
- •that it is physiologically impossible that they could be pregnant and not be aware they are.
- •Women who do not make one of the two declarations above, are only eligible if:
- •they undertake a highly sensitive urine pregnancy test which is negative, prior (and as close in time as is possible) to beginning the treatment phase of the Trial,
- •they agree to use a highly, or acceptably effective, contraceptive measure** during the treatment phase of the Trial.
- •fully healed residual limb (or stump) ***
- •single or multi limb amputation with the intervention applied to the participants limb of choice
- •experienced PLP rated as ≥4 on a 0-10 scale on at least 2 days in the week prior to enrolment
- •agree to inform us of the use of any new (to them) prescribed drug for their pain during the trial
- •any prescribed pharmacological treatment for the treatment of PLP stable for one month prior to commencing the trial , and agree not to undertake any non-pharmacological treatments for their PLP during the trial (e.g., mirror therapy)
- •agree to inform us of any other health care received related to the amputated limb during the trial (e.g., physiotherapy or occupational therapy) whether specific to PLP or not
- •any previous non-pharmacological PLP treatment must have terminated at least 1 month prior to commencing the trial
- •Participants will need access to a mobile smart phone and a device (laptop, iPad etc.) at home to receive text messages and take part in secure video conference calls and completion of online forms.
- •*Post menopause is defined as no menses for 12 months without an alternative medical cause. Permanently sterile methods include hysterectomy, bilateral salpingectomy, and bilateral oophorectomy
- •**Highly effective contraceptive methods being:
- •Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation either oral, intravaginal, or transdermal
- •Progestogen only hormonal contraception associated with inhibition of ovulation, either oral, injectable, or implantable
- •Intrauterine device IUD
- •Intrauterine hormone-releasing system IUS
- •Sexual abstinence
- •Acceptably effective contraceptive methods being:
- •Progestogen-only oral hormonal contraception, where inhibition of ovulation is not the primary mode of action
- •Male or female condom with or without spermicide
- •Cap, diaphragm or sponge with spermicide
- •A combination of male condom with either cap, diaphragm or sponge with spermicide (double barrier methods)
- •Fully healed criteria: no bleeding, no oozing, no broken skin, no obvious sign of infection, such as swelling or redness, around the scar.
排除标准
- •lacking Mental Capacity to give Informed Consent
- •women who self-declare that they are pregnant, or that they will be trying to become pregnant, during the treatment phase of the Trial*
- •impaired sensation as measured by hot/ cold test and sharp/ blunt test
- •unable to read and speak English - the questionnaires being used have not been translated and validated in multiple languages and no facility is available to conduct nor translate/ back-translate semi-structured interview data
- •epileptic
- •active deep vein thrombosis, thrombophlebitis, or varicose veins
- •fitted with a pacemaker
- •has a metal implant in the area to be stimulated
- •any residual limb complications such as cellulitis, wounds, infections etc.
- •Active regions of known or suspected malignancy
- •Any actively bleeding tissue or to persons with untreated haemorrhagic disorders
- •Participating in any research trial of any intervention hypothesised to affect PLP
- •Any current or recent history of substance misuse, alcohol, or drug dependency
- •Any person, otherwise eligible, who commences any non-pharmacological treatment for PLP during the trial period
研究组 & 干预措施
Sensory Retraining Interactive Device
The interactive device is a sensory retraining device. A pad consisting of twelve equally spaced electrodes is placed over the residual limb. This pad is connected to a handheld device which delivers an electrical current to the electrodes. The type of electrical current is similar to a TENS device. The device stimulates the skin via one of the electrodes, with either a single, or a rapid burst of pulse(s). The device touch screen then presents the questions, Which electrode (location) was stimulated? Was a single continuous or a rapid burst of pulses given (stimulation type)? The user responds via the screen and is told if they are correct. If correct, a new stimulus is delivered (different location and type) and the process repeated. If incorrect, the user is informed of the correct response, the same stimulation (location and type) is repeated once before moving onto to a new stimulus.
干预措施: Sensory retraining device (Device)
Placebo Sensory Retraining Non-Interactive Device
The placebo non-interactive device is physically visually identical to the interactive device. This device delivers the stimulation using microcurrents that the participants may or may not feel. There is no interaction required with this device i.e. there is no Q&A element, feedback nor response dependent progression.
干预措施: Sensory retraining device (Device)
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)
- 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)
- 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)
- 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