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

Recruiting

• Conditions: Phantom Limb Pain

• Registration Number: NCT06638918
• Lead Sponsor: University of 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.

Study Timeline

• Study Start: 2024-07-26
• Status Verified: 2024-09
• Study First Submitted: 2024-09-04
• Study First Submitted QC: 2024-10-09
• Last Update Submitted: 2024-10-09
• Study First Posted: 2024-10-14
• Last Update Posted: 2024-10-14
• Primary Completion: 2025-03-30
• Study Completion: 2025-03-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Acceptability	Immediately after intervention is administered	The Theoretical Framework of Acceptability Questionnaire (TFAQ score \> 3 indicates acceptability). Range 1-5 on seven items.
Tolerability of the virtual reality simulation	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.
Engagement	During intervention administration, up to seventeen days	Length of time in minutes spent in the virtual reality program per session (recommended: 20 minutes)

Secondary Outcome Measures

Name	Time	Method
Phantom Limb Pain Intensity	One month follow-up	Brief Pain Inventory (Pain Intensity Only). Range 0-40, higher scores = higher pain intensity.
Phantom Limb Pain Interference	One month follow-up	Patient-Reported Outcome Measurement System Pain Interference Scale-- 8a. Range 8-40, higher score = higher pain interference.
Embodiment	Administered after intervention administration is completed, up to seventeen days	Virtual Embodiment Questionnaire. Range 1-7 for 12 items, higher score = higher embodiment.
Presence	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.

Trial Locations

Locations (1)

Health Sciences Center; 🇨🇦 Winnipeg, Manitoba, Canada