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

NCT06604507 · Status: NOT_YET_RECRUITING · Type: OBSERVATIONAL · Enrollment: 200

Last updated 2024-09-19

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Winfried Meißner

    lead OTHER

Principal Investigators

  • Winfried Meissner, MD · Jena University Hospital

  • Volodymyr Romanenko, MD · Vita Medical

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-10-15
Primary Completion
2026-12-31
Completion
2026-12-31

Countries

  • Ukraine

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06604507 on ClinicalTrials.gov