Status:
COMPLETED
Sensory Retraining for Phantom Limb Pain
Lead Sponsor:
Teesside University
Collaborating Sponsors:
2PD Ltd
Royal Commission for the Exhibition of 1851
Conditions:
Phantom Limb Pain
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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 ele...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
February 9 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 18 2025
Estimated Enrollment :
109 Patients enrolled
Trial Details
Trial ID
NCT04103983
Start Date
February 9 2024
End Date
July 18 2025
Last Update
September 29 2025
Active Locations (1)
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1
Teesside University
Middlesbrough, Tees Valley, United Kingdom, TS1 3BX