Treating lower phantom limb pain in the postoperative acute care setting using virtual reality: Protocol for a four-phase development and feasibility trial (Preprint)
Authors: El-Gabalawy Renée , Crooks Megan , Smith Michael Sean Dyck , Hammond Elizabeth , Gross Patrick , Roznik Marinya , Perrin David , Reynolds Kristin , Logan Gabrielle , Pankratz Lily , Johnson Hilary , Girling Linda , Wiebe Daniel 
Published: November 2024

BACKGROUND

Phantom limb pain (PLP) affects the majority of people living with lower limb amputations (LLAs). Nonpharmacological interventions, such as graded motor imagery (GMI), have demonstrated promise as PLP treatments. However, GMI access is limited by low patient buy-in and long public outpatient wait times. Considering PLP has been shown to be more prevalent and severe immediately following LLA, there is an urgent need to bypass barriers to allow for more prompt access to PLP interventions. In response to this need, the current multidisciplinary research team developed a virtual reality (VR) program that administers GMI treatment. This novel intervention may be completed independently and promptly within the postoperative acute care setting. Prior to a randomized controlled trial, the VR-GMI program must be validated and refined through a rigorous and multi-stage feasibility assessment.

OBJECTIVE

The objective of the current protocol is to outline the development and feasibility of the VR-GMI prototype for treating people with LLAs in the postoperative acute care setting (i.e., inpatient and home settings) through an iterative, patient-centered, and descriptive approach.

METHODS

Four phases of prototype development and assessment are conducted. In Phase 1 (completed), the VR-GMI prototype was developed in collaboration with engineers at the National Research Council (NRC) and in consultation with patient partners. In Phase 2 (completed), people with lived experience were recruited from local physiotherapy and prosthetic clinics to trial the VR-GMI program and provide feedback through semi-structured interviews and self-report measures. Phase 3 (completed) consisted of a descriptive case series of individuals who trialed the VR-GMI prototype immediately following their LLAs in hospital. Results from Phase 3 informed the development of a primary quantitative feasibility study. Phase 4 (underway) aims to evaluate the acceptability and pilot outcomes of the VR-GMI program in hospital and home, as well as improve study procedures for a future randomized controlled trial (Phase 4A). Iterative developments were made to the VR-GMI program between each phase to improve prototype fidelity. These iterative developments will also be reviewed in a series of focus groups to finalize the VR-GMI prototype (Phase 4B).

RESULTS

Recruitment for Phases 1 and 2 were completed in September 2023. Phase 3 was completed in July 2024, and Phase 4A is currently underway.

CONCLUSIONS

The present intervention is the first VR PLP treatment implementing GMI and prioritizing an in-depth, patient-centered approach prior to assessing its efficacy. Doing so will improve the likelihood of successful clinical implementation. Moreover, very few PLP interventions have been assessed in the acute postoperative period when they may prevent PLP before its onset.

CLINICALTRIAL

Phase 4 has been registered on clinicaltrials.gov (#NCT06638918).