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

Official title

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

Overview

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.

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 cal

Primary outcome measures

• To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee. [Time frame: 8 weeks]

Secondary outcome measures (4)

• Usability and acceptability of the app [Time frame: 8 weeks after use of the app]
• Profile of amputees who completed the 8 week treatment protocol vs did not [Time frame: 8 weeks after use of the app]
• Pain-related amputation patient reported outcomes [Time frame: 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 [Time frame: weeks 9 - 12 of app use]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model

Cohort

Study locations

Ukraine · 5 centers

• University Clinic of Kharkiv National Medical University — Kharkiv
• Kyiv Main Military Clinical Hospital — Kyiv
• Odesa 10th City Hospital — Odesa
• Vinnytsia National Medical University — Vinnytsia
• Vinnytsia Prometei Pain Treatment Center — Vinnytsia

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. PMID 25880456
• 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. PMID 31066315
• 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. PMID 38112578

Identifiers

NCT: NCT06604507 · 2023-10-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗