New At-Home devices show promise for phantom limb pain relief
NCT ID NCT04103983
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tested two new devices that use gentle electrical stimulation to help reduce phantom limb pain—pain felt in a missing limb after amputation. One device required the user to interact with it, while the other was non-interactive. 109 adults with phantom limb pain used the devices at home for 3 weeks, with researchers checking in by video calls and texts. The goal was to see which device worked better and if they could safely ease pain.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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109 people
The number who actually took part.
- Started
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Feb 2024
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion criteria * Living in the UK * All Genders * Aged ≥18 years of age * Women who self-declare: * that they are post-menopausal, or permanently sterile\*, \- or - * 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, * and - * 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. Exclusion criteria * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Teesside University
Middlesbrough, Tees Valley, TS1 3BX, United Kingdom
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Botox shot may silence stubborn nerve pain in amputees
- Battlefield injuries: new study seeks to predict chronic pain before it starts
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- New study seeks to uncover hidden pain in child amputees
- Can VR ease phantom limb pain after amputation?