Clinical trial NCT06638918: Assessing the Feasibility of a Virtual Reality Intervention for Phantom Pain Immediately Following Lower Limb Amputation
Official title: Assessing the Feasibility of a Virtual Reality Intervention for Lower Phantom Limb Pain in the Acute Postoperative Period
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Phantom Limb Pain
Keywords: virtual reality
phantom limb pain
lower limb amputation
graded motor imagery
feasibility
acute
Lead sponsor: University of Manitoba
Sponsor class: OTHER
Collaborators: name: Health Sciences Centre, Winnipeg, Manitoba
First posted: 2024-10-15
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Participants will be recruited from population of individuals undergoing lower limb amputation at the Health Sciences Center (a public inpatient tertiary care hospital) in Winnipeg, Manitoba.

Brief summary: The goal of this observational study is to see whether a new virtual reality (VR) program meant to treat phantom limb pain (PLP) is feasible to people immediately following lower limb amputation. This study aims to answer three questions.

1. Is this VR treatment acceptable to people immediately following lower limb amputation?
2. Are the researchers able to recruit participants that represent the population in need of this treatment, and will these participants stay until the end of the study?
3. Do participants who use the VR program more have less severe PLP than participants who use the VR program for fewer sessions?

Participants will:

* Try the VR program in the hospital, their home, and in physiotherapist clinics daily for about seventeen sessions.
* After each session, participants will fill out questionnaires asking about their level of pain, their nausea, and how acceptable they find the program. They will also complete measures asking about how they're feeling and what led to their amputation.
* One month following their final VR session, researchers will phone the participants to ask them to rate how severe their PLP is.

Detailed description: There are many barriers that prevent people with lower limb amputations (LLA) from receiving effective nonpharmacological treatment for their phantom limb pain (PLP), such as long outpatient wait times and the sparse number of amputation rehabilitation specialists. Early administration of effective PLP treatments, such as graded motor imagery (GMI), may improve both treatment access and efficacy if it is administered through virtual reality (VR). However, no VR GMI treatments have been developed or tested in the acute postoperative period following LLA to prevent PLP. The current study will recruit 30 patients being treated for LLA at the Health Sciences Centre (HSC) in Winnipeg, Manitoba to assess the feasibility and pilot outcomes of a novel VR GMI program administered in the postoperative acute care setting, with the goal of preventing and or reducing PLP. First, the researchers predict the mean acceptability, tolerability, and length of engagement in the VR program will be high across administration contexts and each of the VR stages. Second, the researchers hypothesize the recruitment strategies employed will capture and retain a large, representative sample of individuals undergoing LLA at the HSC. Lastly, the researchers predict length of VR program engagement will demonstrate a preliminary effect on PLP incidence, intensity, and interference at one-month follow-up. Baseline characteristics such as anxiety, depression, and amputation etiology will also be explored as extraneous variables. This research will be the first to provide evidence for the feasibility of VR PLP treatment administered immediately following LLA. The results will inform future development of the VR program and optimize the study procedures for an upcoming randomized clinical trial.

Eligibility criteria: Inclusion Criteria:

* if they underwent or are about to undergo an LLA (hip, below-knee, above-knee, or foot) within the last two months
* if they are currently receiving inpatient treatment at the Health Sciences Centre (HSC) in Winnipeg, Canada
* if they can speak/read English fluently

Exclusion Criteria:

* any visual, hearing, or motor impairment that would affect engaging with a head-mounted VR headset or hand controls, as interpreted by the research team or nursing staff

Primary outcomes:
measure: Acceptability
timeFrame: Immediately after intervention is administered
measure: Tolerability of the virtual reality simulation
timeFrame: Immediately before and after intervention administration
measure: Engagement
timeFrame: During intervention administration, up to seventeen days
Secondary outcomes:
measure: Phantom Limb Pain Intensity
timeFrame: One month follow-up
measure: Phantom Limb Pain Interference
timeFrame: One month follow-up
measure: Embodiment
timeFrame: Administered after intervention administration is completed, up to seventeen days
measure: Presence
timeFrame: Administered after intervention administration is completed, up to seventeen days
Other outcomes:
measure: Anxiety
timeFrame: Baseline
measure: Depression
timeFrame: Baseline
Locations:
city: Winnipeg
country: Canada
facility: Health Sciences Center
state: Manitoba
Study officials:
affiliation: Associate Professor and Clinical Psychologist
name: Renee El-Gabalawy, PhD
role: PRINCIPAL_INVESTIGATOR
References: