Feasibility of Using an App for Managing Phantom Limb Pain Associated with Combat Injury in Ukraine (PAMELA)

NCT06604507 | Not Yet Recruiting

• 1 other identifier: 2023-10-01
• Study Type: observational
• Target: 200
• Locations: 1 country
• Sites: 5

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. 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. 2.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; War-Related Trauma

Keywords

Non-pharmacological treatment; App, computer; amputation, traumatic; pain, phantom; pain, acute; pain, chronic; pain, neuropathic; rehabilitation; war-related trauma

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (4)

• Usability and acceptability of the app

  8 weeks after use of the app

• Profile of amputees who completed the 8 week treatment protocol vs did not

  8 weeks after use of the app

• Pain-related amputation patient reported outcomes

  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

  weeks 9 - 12 of app use

Study Arms (1)

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.

Device: non-pharmacological app

Interventions

non-pharmacological app DEVICE

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

Soldiers or civilians, who underwent an amputation as a result of the 2022 war in Ukraine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Winfried Meißner: lead

Study Sites (5)

University Clinic of Kharkiv National Medical University

Kharkiv, Ukraine

Location

Kyiv Main Military Clinical Hospital

Kyiv, Ukraine

Location

Odesa 10th City Hospital

Odesa, Ukraine

Location

Vinnytsia National Medical University

Vinnytsia, Ukraine

Location

Vinnytsia Prometei Pain Treatment Center

Vinnytsia, Ukraine

Location

Related Publications (3)

• 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.

  PMID: 25880456 BACKGROUND

• 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.

  PMID: 31066315 BACKGROUND

• 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.

  PMID: 38112578 BACKGROUND

Related Links

• 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.

MeSH Terms

Conditions

Amputation, Traumatic; Phantom Limb; Acute Pain; Chronic Pain; Neuralgia; War-Related Injuries; Alzheimer Disease

Condition Hierarchy (Ancestors)

Wounds and Injuries; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain; Peripheral Nervous System Diseases; Neuromuscular Diseases; Dementia; Brain Diseases; Central Nervous System Diseases; Tauopathies; Neurodegenerative Diseases; Neurocognitive Disorders; Mental Disorders

Study Officials

• Winfried Meissner, MD

  Jena University Hospital

  PRINCIPAL INVESTIGATOR

• Volodymyr Romanenko, MD

  Vita Medical

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Ruth Zaslansky, DSc

CONTACT

+4915734955841; ruth.zaslansky@med.uni-jena.de

Winfried Meissner, MD

CONTACT

WINFRIED.Meissner@med.uni-jena.de

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Winfried Meissner

Study Record Dates

• First Submitted: September 17, 2024
• First Posted: September 19, 2024
• Study Start: October 15, 2024
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: September 19, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• 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

Locations

UA (5)