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Completed

NCT Number: NCT06638918

Assessing the Feasibility of a Virtual Reality Intervention for Phantom Pain Immediately Following Lower Limb Amputation

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.

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Key information

Conditions

Phantom Limb Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Phantom Limb Postoperative Complications Signs and Symptoms

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Health Sciences Center

Winnipeg, Manitoba, R3E 0Z2, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Virtual reality

Device

The virtual reality (VR) intervention administers graded motor imagery (GMI) treatment for phantom limb pain. It consists of three stages: left right sorting task (a sorting task where participants sort images of left and right feet), explicit motor imagery (a series of guided imagery exercises administered via audio to facilitate focus on the phantom limb), and the limb simulation task (where participants perform a series of exercises with virtual legs to create the illusion of movement in their phantom limb). The limb simulation stage can also be conducted with leg trackers to generate a higher degree of illusion in the virtual legs.

Primary outcomes

  1. Acceptability

    Time frame: Immediately after intervention is administered

    The Theoretical Framework of Acceptability Questionnaire (TFAQ score > 3 indicates acceptability). Range 1-5 on seven items.

  2. Tolerability of the virtual reality simulation

    Time frame: Immediately before and after intervention administration

    Numerical Rating Scale for phantom limb pain, residual limb pain (i.e., physical pain at the amputation site), nausea (NRS > 2 on any construct indicates an adverse event and lack of tolerability). Range 0-10 on each NRS.

  3. Engagement

    Time frame: During intervention administration, up to seventeen days

    Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes)

Secondary outcomes

  1. Phantom Limb Pain Intensity

    Time frame: One month follow-up

    Brief Pain Inventory (Pain Intensity Only). Range 0-40, higher scores = higher pain intensity.

  2. Phantom Limb Pain Interference

    Time frame: One month follow-up

    Patient-Reported Outcome Measurement System Pain Interference Scale-- 8a. Range 8-40, higher score = higher pain interference.

  3. Embodiment

    Time frame: Administered after intervention administration is completed, up to seventeen days

    Virtual Embodiment Questionnaire. Range 1-7 for 12 items, higher score = higher embodiment.

  4. Presence

    Time frame: Administered after intervention administration is completed, up to seventeen days

    iGroup Presence Questionnaire. Range -3 to +3 for each of 14 items, higher score = higher presence.

Other outcomes

  1. Anxiety

    Time frame: Baseline

    Generalized Anxiety Disorder 7. Range 0 to 21, higher score = higher anxiety.

  2. Depression

    Time frame: Baseline

    Patient Health Questionnaire 9. Range 0 to 27, higher score = higher depressive symptoms.

Sponsors and collaborators

Lead sponsor

University of Manitoba

Other

Collaborators

  • Health Sciences Centre, Winnipeg, Manitoba

Registry information

Official study title

Assessing the Feasibility of a Virtual Reality Intervention for Lower Phantom Limb Pain in the Acute Postoperative Period

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Oct 15, 2024
Registry last updated
Jan 26, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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