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Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (PAMELA)

W

Winfried Meißner

Status

Not yet enrolling

Conditions

War-Related Trauma
Rehabilitation
Pain, Phantom
Amputation, Traumatic
Pain, Acute
Pain, Chronic
Pain, Neuropathic

Treatments

Device: non-pharmacological app

Study type

Observational

Funder types

Other

Identifiers

NCT06604507
2023-10-01

Details and patient eligibility

About

In Ukraine, since the beginning of the full-scale war on February 24, 2022, a large number of individuals have lost a limb(s). Many of these amputees cannot access appropriate care in terms of pain management and rehabilitation. Consequently, healthcare providers in Ukraine have been seeking assistance from international, professional bodies to improve the care offered to amputees - soldiers and civilians.

Pain related to an amputation is chronic and so non-pharmacological approaches, rather than pharmacological, are appealing. In Germany, Routine Health, in Düsseldorf, have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques.

In the PAMELA project, we will offer amputees and therapists in Ukraine, use of this app.

The app has been adapted for use in Ukraine.

The study will be carried out in 2 phases:

  1. A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle, tailored to each amputee; amputees will be offered to use the app for another 4 weeks, independently
  2. Updating the app, based on experience gained in the pilot phase and sharing the app with amputees who wish to us it.

Full description

In Ukraine, since the beginning of the full-scale war on February 24, 2022, approximately 50,000 individuals have lost a limb(s). Many of these amputees cannot access appropriate care in terms of pain management and rehabilitation. Consequently, healthcare providers in Ukraine have been seeking assistance from international, professional bodies to improve the care offered to amputees - soldiers and civilians.

The protocol outlined here is of a study which will offer amputees, and their therapists in Ukraine, support in treating pains associated with amputation, using non-pharmaceutical methods.

Pain related to an amputation is chronic and so non-pharmacological approaches, rather than pharmacological, are appealing. In Germany, Routine Health, in Düsseldorf, have developed an app-based platform which offers amputees a variety of non-pharmacological management techniques. In Germany, the app is s used by amputees injured in work-related accidents. The developers have gained extensive experience over the last 7 years in terms of the app's usability and its effect on amputation-related pains.

In the PAMELA project, we will offer amputees and therapists in Ukraine, use of this app. We anticipate that an app-based solution can be feasible as many of the amputees are young and, therefore, computer savvy, many as said to be motivated to regain their independence after their injury. With the limited resources in terms of availability healthcare professionals in Ukraine, we anticipate that offering amputees an app-based tool, which can be, used in different environments, hospital, rehabilitation centers or home, at different phases of their treatment, might be an effective and cost effective means for managing amputation-related pains.

The app has been adapted for use in Ukraine - modules have been translated into Ukrainian and we devised methodology for assessing demographics of the amputees, information about the injury and amputation-related pain and other symptoms. The literature stresses that when proving this form of non-pharmacological management, it is important to select suitable candidates, train them and tailor their care. Thus, at least for the first phase of the study (='pilot'), staff from Routine Health will train Ukrainian therapists (physiotherapists and occupational therapists) from 5 centers on how to use the app and they will recruit amputees in the center in which they work.

The study will be carried out in 2 phases:

  1. A pilot in 5 rehabilitation centers to assess feasibility of using the app during one pre-defined 8-week treatment cycle, tailored to each amputee; amputees will be offered to use the app for another 4 weeks, independently
  2. Updating the app, based on experience gained in the pilot phase and sharing the app with amputees who wish to us it.

Enrollment

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Amputee has given written informed consent for participation in the study.
  • Male or Female
  • Age - no restriction but adult
  • Have undergone amputation of one limb, upper or lower.

Exclusion criteria

For Graded Motor Imagery / Mirror therapy Amputees with disorders such as post-traumatic stress disorders should perform mirror therapy only after initial assessment by the therapist carrying out the treatment, as the mirror image of two intact limbs might elicit memories associated with the trauma

Trial design

200 participants in 1 patient group

Soldiers or civilians, who underwent an amputation as a result of the 2022 war in Ukraine
Description:
The cohort consists of soldiers or civilians, who underwent an amputation as a result of the 2022 war in Ukraine, and will use an app that provides non-pharmaceutical methods to care for the sensations and pains related to amputation.
Treatment:
Device: non-pharmacological app

Trial contacts and locations

5

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Central trial contact

Ruth Zaslansky, DSc; Winfried Meissner, MD

Data sourced from clinicaltrials.gov

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