Clinical trial NCT06604507: Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (PAMELA)
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
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Amputation, Traumatic
Pain, Phantom
Pain, Acute
Pain, Chronic
Pain, Neuropathic
Rehabilitation
War-Related Trauma
Keywords: Non-pharmacological treatment
App, computer
amputation, traumatic
pain, phantom
pain, acute
pain, chronic
pain, neuropathic
rehabilitation
war-related trauma
Lead sponsor: Jena University Hospital
Sponsor class: OTHER
First posted: 2024-09-19
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: People in Ukraine, soldiers or civilians, who have undergone an amputation of one limb, upper or lower, since the 2022 war.

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.

Eligibility criteria: 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

Primary outcomes:
measure: To assess the feasibility of amputees completing a pre-defined 8-week Routine Health treatment protocol, tailored to each amputee.
timeFrame: 8 weeks
Secondary outcomes:
measure: Usability and acceptability of the app
timeFrame: 8 weeks after use of the app
measure: Profile of amputees who completed the 8 week treatment protocol vs did not
timeFrame: 8 weeks after use of the app
measure: Pain-related amputation patient reported outcomes
timeFrame: Baseline, weekly for 12 weeks (8 weeks treatment with therapist, 4 weeks independent use)
measure: Profile of amputees who completed the 4 week independent use of the app vs did not
timeFrame: weeks 9 - 12 of app use
Other outcomes:
Locations:
city: Kharkiv
country: Ukraine
facility: University Clinic of Kharkiv National Medical University
city: Kyiv
country: Ukraine
facility: Kyiv Main Military Clinical Hospital
city: Odesa
country: Ukraine
facility: Odesa 10th City Hospital
city: Vinnytsia
country: Ukraine
facility: Vinnytsia National Medical University
city: Vinnytsia
country: Ukraine
facility: Vinnytsia Prometei Pain Treatment Center
Study officials:
affiliation: Jena University Hospital
name: Winfried Meissner, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vita Medical
name: Volodymyr Romanenko, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: Rothgangel 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.
citation: Kumar 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.