Amputation, Traumatic, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Pain, Phantom, Rehabilitation, War-Related Trauma
Conditions
Keywords
Non-pharmacological treatment, App, computer, amputation, traumatic, pain, phantom, pain, acute, pain, chronic, pain, neuropathic, rehabilitation, war-related trauma
Brief 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.
Interventions
DEVICEnon-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
Winfried Meißner
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee. | 8 weeks | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Usability and acceptability of the app | 8 weeks after use of the app | Assess usability and acceptability of the app by amputees & carers at 8 weeks. |
| Profile of amputees who completed the 8 week treatment protocol vs did not | 8 weeks after use of the app | 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 |
| Pain-related amputation patient reported outcomes | Baseline, weekly for 12 weeks (8 weeks treatment with therapist, 4 weeks independent use) | 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. |
| Profile of amputees who completed the 4 week independent use of the app vs did not | weeks 9 - 12 of app use | Assess the profile of patients who wished to continue using the app, independently, for an additional 4 weeks. |
Countries
Ukraine
Contacts
Primary ContactRuth Zaslansky, DSc
Backup ContactWinfried Meissner, MD
Outcome results
None listed