NCT06604507Not yet recruiting
Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (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
Source: ClinicalTrials.gov · Last updated 19 Sept 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Observational
- Enrollment
- 200 (estimated)
- First submitted
- 17 Sept 2024
- Start date
- 15 Oct 2024
- Primary completion date
- 31 Dec 2026
- Lead sponsor
- Winfried Meißner
- NCT number
- NCT06604507
What you commit to
- Study type: Observational
- Planned participants: 200
- From 15 Oct 2024 to the primary completion date, 31 Dec 2026
- 5 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (5)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University Clinic of Kharkiv National Medical University Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Kyiv Main Military Clinical Hospital Coordinator of this site? Confirm its status | Kyiv | Ukraine | Unknown status |
| Odesa 10th City Hospital Coordinator of this site? Confirm its status | Odesa | Ukraine | Unknown status |
| Vinnytsia National Medical University Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Vinnytsia Prometei Pain Treatment Center Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.