An observational study in Amputation, Traumatic, Pain, Phantom and Pain, Acute, sponsored by Winfried Meißner. Not yet recruiting at 5 sites in Ukraine. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-09-19.
Sponsored by Winfried Meißner · Observational
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:
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:
112 studies on the registry are indexed under Amputation, Traumatic; 24 are open to participants now.
This study's planned enrollment of 200 is above the median of 37 across 34 observational studies indexed under Amputation, Traumatic.
Browse Amputation, Traumatic studies →This is the only study on the registry with Winfried Meißner as lead sponsor.
Counted across the registry records on this site, refreshed daily.
People in Ukraine, soldiers or civilians, who have undergone an amputation of one limb, upper or lower, since the 2022 war.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
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
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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.
Time frame: 8 weeks
Usability and acceptability of the app
Assess usability and acceptability of the app by amputees \& carers at 8 weeks.
Time frame: 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
Time frame: 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.
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
Assess the profile of patients who wished to continue using the app, independently, for an additional 4 weeks.
Time frame: weeks 9 - 12 of app use
Plan to share: Yes — 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.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form, Clinical study report
Time frame: The IPD will be available for sharing following publication of the study results and will remain accessible for up to 5 years.
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
Data sharing details ↗ · pamela.in.ua
Start is estimated for Oct 2024; primary completion for Dec 2026, 26 months later.
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This study is not yet recruiting, as verified in Aug 2024. You cannot join it, but the record below documents what was studied.
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