Sensory Retraining for Phantom Limb Pain (PHANTOM RELIEF)
Phantom Limb Pain
About this trial
This is an interventional treatment trial for Phantom Limb Pain
Eligibility Criteria
Inclusion Criteria:
- Living in the UK
- All Genders
- Aged ≥18 years of age
- People who self-declare at that they are not pregnant and could never become pregnant.
Anyone who does not make both of those self-declarations:
- if it is at all possible (self-declaration at eligibility checking) they may be pregnant before the Trial but not know they are - will be required to undertake a highly sensitive urine pregnancy test (as close in time as possible to the first video call) and return (and share at the first videocall) a negative result and/or
- if it is at all possible (self-declaration at eligibility checking) that they may become pregnant, during the 21 days they will be using a device - will be required to use a form of contraception considered to be highly or acceptably effective by the Clinical Trials Facilitation and Coordination Group (CTFG, 2020) (listed below*)
- 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 study
- any prescribed pharmacological treatment for the treatment of PLP stable for one month prior to commencing the study, and agree not to undertake any non-pharmacological treatments for their PLP during the study (e.g., mirror therapy)
- agree to inform us of any other health care received related to the amputated limb during the study (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 study
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.
* 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) (CTFG, 2020).
- Fully healed criteria: no bleeding, no oozing, no broken skin, no obvious sign of infection, such as swelling or redness, around the scar.
Exclusion Criteria:
- lacking Mental Capacity to give Informed Consent
- people who self-declare that they are pregnant
- people who self-declare that they will be trying to become pregnant, during the 21 days they will be using a device
- 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 study period
Sites / Locations
- Teesside University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Active Comparator
Placebo Comparator
Active Comparator
Placebo Comparator
Sensory Retraining Interactive Device
Placebo Sensory Retraining Interactive Device
Sensory Retraining Non-Interactive Device
Placebo Sensory Retraining Non-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.
The placebo device is visually identical to the active device
The 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.
The placebo device is visually identical to the active device