Treatment for pain in amputated limbs using sensory retraining

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]

This study is testing two new devices to see if they can help people with amputated limbs feel less phantom limb pain.

Quick facts

• Phase: Not applicable
• Study type: Interventional
• Enrollment: 100 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Teesside University (Academic / other)
• Locations: 1 site (Middlesbrough, Tees Valley)
• Trial ID: NCT04103983 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of two new sensory retraining devices designed to alleviate phantom limb pain (PLP) in individuals who have undergone amputation. Participants will be randomly assigned to use either an interactive or a non-interactive device that delivers electrical stimulation to the residual limb. The study will be conducted remotely, utilizing video calls, telephone, and email for communication. A total of 100 participants will be recruited from the NHS and the general public to assess the efficacy of both devices in reducing PLP.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older living in the UK who have experienced a single or multi-limb amputation and have a fully healed residual limb.

Not a fit: Patients who are pregnant or may become pregnant during the trial period will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly reduce phantom limb pain for amputees, improving their quality of life.

How similar studies have performed: While the approach of using sensory retraining for PLP is relatively novel, similar studies have shown promise in addressing chronic pain through sensory stimulation techniques.

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).

Where this trial is running

Middlesbrough, Tees Valley

• Teesside University — Middlesbrough, Tees Valley, United Kingdom (Recruiting)

Study contacts

• Principal investigator: Cormac Ryan, Professor — Teesside University
• Study coordinator: Cormac Ryan, Professor

Conditions Phantom Limb Pain