Amputation, TraumaticPAMELANCT06604507
Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (PAMELA)
An observational study of Amputation, Traumatic and Pain, Phantom, run by Winfried Meißner at 5 sites in Ukraine.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Amputation, Traumatic, Pain, Phantom, Pain, Acute
- What is being tested?
- non-pharmacological app
- Type of treatment
- Medical device
- How many people
- 200 participants
- Where
- 5 sitesUkraine
- Study dates
- 15 Oct 2024to 31 Dec 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: People in Ukraine, soldiers or civilians, who have undergone an amputation of one limb, upper or lower, since the 2022 war.
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Winfried Meissner, MD contact
5 sites in 1 country
Ukraine5 sites
University Clinic of Kharkiv National Medical University
Kharkiv
Volodymyr Korostiy, MD
Kyiv Main Military Clinical Hospital
Kyiv
Vasyl Horoshko, MD
Odesa 10th City Hospital
Odesa
Rybak Vasyl, MD
Vinnytsia National Medical University
Vinnytsia
Serhii Kolisnyk, MD
Vinnytsia Prometei Pain Treatment Center
Vinnytsia
Dmytro Dmitriev, MD
About this study
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
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.
Read more
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:
- 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
- Updating the app, based on experience gained in the pilot phase and sharing the app with amputees who wish to us it.
Read the 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:
- 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
- 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
- Being tested
- non-pharmacological app
- Keywords
- Non-pharmacological treatment, App, computer, amputation, traumatic, pain, phantom, pain, acute, pain, chronic, pain, neuropathic, rehabilitation, war-related trauma
- Medical subject headings
- Amputation, Traumatic, Phantom Limb, Acute Pain, Chronic Pain, Neuralgia, War-Related Injuries, Alzheimer Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-pharmacological appDevice
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: non-pharmacological app |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 8 weeks
Secondary outcomes (4)
Usability and acceptability of the app
Assess usability and acceptability of the app by amputees \& carers at 8 weeks.
Measured: 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
Measured: 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.
Measured: 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.
Measured: weeks 9 - 12 of app use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start15 Oct 2024 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Amputation, TraumaticStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Winfried Meißner
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Winfried Meißner, Jena University Hospital
- Investigators
- Winfried Meissner, MD, Principal investigator, Jena University HospitalVolodymyr Romanenko, MD, Principal investigator, Vita Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06604507
- Sponsor's protocol ID
- 2023-10-01
- Acronym
- PAMELA
- Status last verified
- Aug 2024
- First submitted
- 17 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
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.
PubMed 25880456Rothgangel 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.
PubMed 31066315Kumar 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.
PubMed 38112578
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06604507
- Acronym / sponsor ID
- PAMELA / 2023-10-01
- Conditions
- Amputation, Traumatic, Pain, Phantom, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Rehabilitation
- Keywords
- Non-pharmacological treatment, App, computer, amputation, traumatic, pain, phantom, pain, acute, pain, chronic, pain, neuropathic, rehabilitation
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Winfried MeißnerUniversity, hospital or other
- Study start
- 15 Oct 2024 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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
- 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:
- 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
- Updating the app, based on experience gained in the pilot phase and sharing the app with amputees who wish to us it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Soldiers or civilians, who underwent an amputation as a result of the 2022 war in Ukraine | – | Device: non-pharmacological appThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- People in Ukraine, soldiers or civilians, who have undergone an amputation of one limb, upper or lower, since the 2022 war.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non-pharmacological appAmputees 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 | Device | Soldiers or civilians, who underwent an amputation as a result of the 2022 war in Ukraine |
Primary outcome
To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee.
Time frame: 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.
4 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Background: PubMed 25880456Rothgangel 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.
- Background: PubMed 31066315Rothgangel 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.
- Background: PubMed 38112578Kumar 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.
- 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.Link provided by the sponsor.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Winfried Meissner, MD contact
Winfried Meissner, MD principal investigator
Jena University Hospital
Volodymyr Romanenko, MD principal investigator
Vita Medical
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Amputation, Traumatic and Pain, Phantom, run by Winfried Meißner at 5 sites in Ukraine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ruth Zaslansky, DSc (+4915734955841, ruth.zaslansky@med.uni-jena.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee. (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06604507, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Sep 2024.