Trials / Not Yet Recruiting

Not Yet RecruitingNCT06604507

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

Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Amputation in Ukraine: a Quantitative & Qualitative Observational Trial in the 'Prevention and Management of Phantom Limb Pain' Project

Status: Not Yet Recruiting
Phase: —
Study type: Observational
Enrollment: 200 (estimated)

Sponsor: Winfried Meißner · Academic / Other
Sex: All
Age: 18 Years
Healthy volunteers: Not accepted

Summary

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.

Detailed 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.

Conditions

Interventions

Type	Name	Description
DEVICE	non-pharmacological app	Amputees will be offered use of an app which offers a variety of non-pharmacological management techniques and exercises aimed at reducing the sensations and pain which are associated with amputation. These include: (1) offering information about the amputation, (2) augmented reality, this is a method for altering a person's perception about the real-world environment using computer simulation; (3) methods for reducing stress, also called 'Mindfulness-Based-Stress-Reduction' and (4) a method called 'Graded Motor Imagery' which aims to train the brain to address the changes which have occurred due to the amputation and which are related to pain and challenges with movement

Timeline

Start date: 2024-10-15
Primary completion: 2026-12-31
Completion: 2026-12-31
First posted: 2024-09-19
Last updated: 2024-09-19

Locations

5 sites across 1 country: Ukraine

Source: ClinicalTrials.gov record NCT06604507. Inclusion in this directory is not an endorsement.