Sensory Retraining for Phantom Limb Pain

Launched by TEESSIDE UNIVERSITY · Sep 23, 2019

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for phantom limb pain (PLP), which is the pain that many people feel in a limb that has been amputated. The trial will compare two different devices that use electrical stimulation to help reduce pain. One device requires the user to interact with it, while the other works automatically without user input. Researchers want to find out which device is more effective in relieving pain.

To participate, you need to be at least 18 years old, live in the UK, and have a fully healed residual limb. You should have experienced PLP rated at 4 or higher on a scale of 0 to 10 in the week before joining the study. Participants will use their assigned device at home for three weeks while staying in touch with researchers through video calls, phone calls, and texts. Pain levels and function will be measured before and after the treatment, and a follow-up will occur three months later. This study will help understand how well these new devices work and could lead to better treatments for those suffering from phantom limb pain.

Gender

ALL

Eligibility 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.
• • 4.1.2 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
• • known allergy to acrylates\*\*\*
• • 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 or defibrillator (internal or external), implanted neurostimulator, programmable hydrocephalus shunt, cochlear implants, ECG monitors or infusion pumps.
• • 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
• • Acrylates can be found in solvent adhesives such as super glue, artificial nail products, nail and eyelash adhesives, hair extensions, denture products and medical adhesives used for dressings, plasters. And body worn sensors (such as blood glucose monitors).