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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Rehabilitation; Pain, Acute; Pain, Chronic; Amputation, Traumatic; Pain, Phantom; War-Related Trauma; Pain, Neuropathic
• Intervention / Treatment: Device: non-pharmacological app

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.

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Ruth Zaslansky, DSc; Phone Number: +4915734955841; Email: ruth.zaslansky@med.uni-jena.de
• Study Contact Backup: Name: Winfried Meissner, MD; Email: WINFRIED.Meissner@med.uni-jena.de

Study Locations

• Ukraine
  • Kharkiv, Ukraine
    • University Clinic of Kharkiv National Medical University
    • Contact: Volodymyr Korostiy, MD
  • Kyiv, Ukraine
    • Kyiv Main Military Clinical Hospital
    • Contact: Vasyl Horoshko, MD
  • Odesa, Ukraine
    • Odesa 10th City Hospital
    • Contact: Rybak Vasyl, MD
  • Vinnytsia, Ukraine
    • Vinnytsia National Medical University
    • Contact: Serhii Kolisnyk, MD
  • Vinnytsia, Ukraine
    • Vinnytsia Prometei Pain Treatment Center
    • Contact: Dmytro Dmitriev, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

People in Ukraine, soldiers or civilians, who have undergone an amputation of one limb, upper or lower, since the 2022 war.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Soldiers or civilians, who underwent an amputation as a result of the 2022 war in Ukraine; 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee.	To assess the feasibility of amputees cared for in rehabilitation centers in Ukraine being able to complete a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee. This includes [i] whether the protocol was followed in terms of implementing the modules (duration & frequency) and [ii] whether the assessments of the amputation-related outcomes, at the different assessment time points, were filled in.	8 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Usability and acceptability of the app	Assess usability and acceptability of the app by amputees & carers at 8 weeks.	8 weeks after use of the app
Profile of amputees who completed the 8 week treatment protocol vs did not	Assess the profile of patients who were able to complete the 8-week treatment protocol vs those who did not. Assess in terms of demographics, type of injury, character of pain	8 weeks after use of the app
Pain-related amputation patient reported outcomes	Assess information about pain-related patient reported outcomes obtained from the assessments carried out at baseline (=anamnesis), once weekly during the 8 week treatment and once weekly for another 4 weeks of independent use.	Baseline, weekly for 12 weeks (8 weeks treatment with therapist, 4 weeks independent use)
Profile of amputees who completed the 4 week independent use of the app vs did not	Assess the profile of patients who wished to continue using the app, independently, for an additional 4 weeks.	weeks 9 - 12 of app use

Collaborators and Investigators

• Sponsor: Winfried Meißner
• Investigators: Principal Investigator: Winfried Meissner, MD, Jena University Hospital; Principal Investigator: Volodymyr Romanenko, MD, Vita Medical

Publications and helpful links

General Publications

• Rothgangel A, Braun S, de Witte L, Beurskens A, Smeets R. Development of a Clinical Framework for Mirror Therapy in Patients with Phantom Limb Pain: An Evidence-based Practice Approach. Pain Pract. 2016 Apr;16(4):422-34. doi: 10.1111/papr.12301. Epub 2015 Apr 16.
• Rothgangel A, Braun S, Smeets R, Beurskens A. Feasibility of a traditional and teletreatment approach to mirror therapy in patients with phantom limb pain: a process evaluation performed alongside a randomized controlled trial. Clin Rehabil. 2019 Oct;33(10):1649-1660. doi: 10.1177/0269215519846539. Epub 2019 May 8.
• Kumar A, Soliman N, Gan Z, Cullinan P, Vollert J, Rice ASC, Kemp H. A systematic review of the prevalence of postamputation and chronic neuropathic pain associated with combat injury in military personnel. Pain. 2024 Apr 1;165(4):727-740. doi: 10.1097/j.pain.0000000000003094. Epub 2023 Dec 15.

Helpful Links

• The website is intended for multidisciplinary healthcare providers, amputees and their families in Ukraine. It will offer information about surgery, pain management and rehabilitation of amputation, which an emphasis of traumatic amputation.

Study record dates

Study Major Dates

• Study Start (Estimated): October 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026

Study Registration Dates

• First Submitted: September 17, 2024
• First Submitted That Met QC Criteria: September 17, 2024
• First Posted (Estimated): September 19, 2024

Study Record Updates

• Last Update Posted (Estimated): September 19, 2024
• Last Update Submitted That Met QC Criteria: September 17, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Keywords: rehabilitation; Non-pharmacological treatment; pain, chronic; pain, neuropathic; App, computer; amputation, traumatic; pain, phantom; pain, acute; war-related trauma
• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Postoperative Complications; Pain; Neurologic Manifestations; Wounds and Injuries; Neurobehavioral Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Perceptual Disorders; Pain, Postoperative; Chronic Pain; Neuralgia; Acute Pain; Amputation, Traumatic; Phantom Limb; War-Related Injuries
• Other Study ID Numbers: 2023-10-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Individual participant data collected during this study will be available for sharing with researchers. The data shared will include de-identified participant demographic information, longitudinal pain-related patient reported outcomes, information about the amputation.
• IPD Sharing Time Frame: The IPD will be available for sharing following publication of the study results and will remain accessible for up to 5 years.

IPD Sharing Access Criteria

Data will be available upon reasonable request to researchers affiliated with academic, research, or healthcare institutions.

Researchers interested in accessing the data will be required to submit a detailed research proposal outlining the intended use of the data.

Sharing of the data will be contingent to approval from the study PIs and to researchers signing a data use agreement.

People wishing to access data should write to:

WINFRIED.Meissner@med.uni-jena.de

• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No