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Clinical Trial NCT06604507 (PAMELA) for Amputation, Traumatic, Pain, Phantom, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Rehabilitation, War-Related Trauma is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (PAMELA) 200 International
Clinical Trial NCT06604507 (PAMELA) is an observational study for Amputation, Traumatic, Pain, Phantom, Pain, Acute, Pain, Chronic, Pain, Neuropathic, Rehabilitation, War-Related Trauma and is currently not yet recruiting. Enrollment is planned to begin on October 15, 2024 and continue until the study accrues 200 participants. Led by Winfried Meißner, this study is expected to complete by December 31, 2026. The latest data from ClinicalTrials.gov was last updated on September 19, 2024.
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 rela...
Show MoreDetailed 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 pr...
Show MoreOfficial 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
Conditions
Amputation, TraumaticPain, PhantomPain, AcutePain, ChronicPain, NeuropathicRehabilitationWar-Related TraumaPublications
Scientific articles and research papers published about this clinical trial:Other Study IDs
- PAMELA
- 2023-10-01
NCT ID Number
Start Date (Actual)
2024-10-15
Last Update Posted
2024-09-19
Completion Date (Estimated)
2026-12-31
Enrollment (Estimated)
200
Study Type
Observational
Status
Not yet recruiting
Keywords
Non-pharmacological treatment
App, computer
amputation, traumatic
pain, phantom
pain, acute
pain, chronic
pain, neuropathic
rehabilitation
war-related trauma
App, computer
amputation, traumatic
pain, phantom
pain, acute
pain, chronic
pain, neuropathic
rehabilitation
war-related trauma
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
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. | 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 reduci...Show More |
Primary Outcome Measures
Secondary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
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. | 8 weeks |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Usability and acceptability of the app | Assess usability and acceptability of the app by amputees \& carers at 8 weeks. | 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 | 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. | 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. | weeks 9 - 12 of app use |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
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
Winfried MeißnerStudy Responsible Party
Winfried Meißner, Sponsor-Investigator, Winfried Meissner, Jena University Hospital
Study Central Contact
Contact: Ruth Zaslansky, DSc, +4915734955841, [email protected]
Contact: Winfried Meissner, MD, [email protected]
5 Study Locations in 1 Countries
University Clinic of Kharkiv National Medical University, Kharkiv, Ukraine
Volodymyr Korostiy, MD, Contact
Kyiv Main Military Clinical Hospital, Kyiv, Ukraine
Vasyl Horoshko, MD, Contact
Odesa 10th City Hospital, Odesa, Ukraine
Rybak Vasyl, MD, Contact
Vinnytsia National Medical University, Vinnytsia, Ukraine
Serhii Kolisnyk, MD, Contact
Vinnytsia Prometei Pain Treatment Center, Vinnytsia, Ukraine
Dmytro Dmitriev, MD, Contact