Clinical trial NCT06956508: Prophylactic TBR on Phantom Limb Pain
Official title: Assessing the Impact of Prophylactic Targeted Brain Rehabilitation (TBR) on Phantom Limb Pain in the Perioperative Period Following Major Amputation, A Prospective Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Phantom Limb Pain After Amputation
Keywords: Phantom Limb Pain
Targeted Brain Rehabilitation
VR
Virtual Reality
Lead sponsor: OrthoCarolina Research Institute, Inc.
Sponsor class: OTHER
First posted: 2025-05-04
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All Control Group patients will be retrospective subjects. Treatment Groups will be a single intervention enrolled prospectively.
Primary purpose: TREATMENT

Brief summary: This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP).

Detailed description: Phantom limb pain (PLP) affects 60-80% of amputees, including both upper and lower extremity amputees, leading to increased anxiety, depression, and reduced quality of life. With the total prevalence of major limb amputees in the United States projected to reach 3 million by 2050 and approximately 185,000 new cases annually, there is a pressing need for effective interventions to prevent and manage PLP.

Current pharmacologic treatments offer limited relief and can lead to adverse outcomes, particularly with long-term opioid use. Non-pharmacologic alternatives, such as mirror therapy, lack strong evidence supporting their efficacy and, to our knowledge, have not been evaluated in the perioperative period.

Virtual reality (VR) has emerged as a promising tool for mitigating various aspects of the phantom limb experience in major limb amputees. Previous research has shown that VR treatments can significantly reduce PLP, with many studies reporting a drop in numeric pain scores after VR use, and can be cost-effective. However, current literature on VR therapy for PLP has never evaluated its use in the immediate post operative period.

Initiating VR therapy immediately post-amputation may help in preventing maladaptive cortical reorganization, which is believed to be a key factor in the development of PLP. Following amputation, the sensory-motor cortex undergoes rapid rewiring as the brain attempts to compensate for the loss of sensory input from the amputated limb. This reorganization can lead to the formation of aberrant neural connections, contributing to the perception of phantom limb sensations and pain. By providing a virtual representation of the missing limb and facilitating its movement, VR therapy may be able to help maintain the integrity of the sensory-motor cortex, potentially preventing or reducing the development of PLP.

Our research team hypothesizes that prophylactic use of Targeted Brain Rehabilitation (TBR), a VR-based therapy system, in the perioperative period following major amputation can prevent or reduce the development of PLP and decrease the usage of opioids in this population. Furthermore, introducing VR therapy in the immediate post-operative period could help mitigate the psychological distress associated with amputation. By addressing both the physical and psychological aspects of amputation from the outset, prophylactic VR therapy has the potential to significantly improve the quality of life for amputees and reduce the long-term burden of PLP. Establishing the efficacy of prophylactic TBR in the perioperative period could revolutionize the standard of care for amputees, potentially reducing the incidence and severity of PLP and its associated psychological and quality of life impacts. This study will lay the groundwork for future multi-center, randomized controlled trials to validate the effectiveness of prophylactic TBR and establish it as a potential standard of care for amputees.

Eligibility criteria: Inclusion Criteria:

* 13+ year old patients undergoing major amputation with Dr. Gaston and Dr. Loeffler in the 12-24 months after the start of this study.
* Ability to read and comprehend English.
* Willing to use VR daily while in the inpatient setting following major amputation.

Exclusion Criteria:

* Patients under 12 years of age, and patients aged 13-17 without a legal guardian to give consent.
* Have used TBR extensively in the past for prior/unrelated amputation.
* Active uncontrolled mental illness
* Active neurological disease or cognitive impairment that would interfere with VR therapy or survey completion.
* Non-English speaking (surveys will only be provided in English)

Primary outcomes:
measure: Short Form McGill Pain Questionnaire (SF-MPQ)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Numeric Pain Rating Scale (NPRS)
timeFrame: Through study completion, an average of 1 year
measure: Brief Pain Inventory (BPI) - Short Form
timeFrame: Through study completion, an average of 1 year
measure: Phantom Limb Experience Survey
timeFrame: Through study completion, an average of 1 year
measure: Phantom Limb Assessment
timeFrame: Through study completion, an average of 1 year
measure: Simulator Sickness Questionnaire
timeFrame: Through study completion, an average of 1 year
measure: System Usability Scale (SUS)
timeFrame: Through study completion, an average of 1 year
measure: Overall VR experience and feedback survey
timeFrame: Through study completion, an average of 1 year
measure: EuroQol five-dimensional health questionnaire (EQ-5D-5L)
timeFrame: Through study completion, an average of 1 year
measure: Patient Health Questionnaire-9 (PHQ-9)
timeFrame: Through study completion, an average of 1 year
measure: Daily Pain Log - Additional Questions
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: Charlotte
country: United States
facility: OrthoCarolina Research Institute
state: North Carolina
Study officials:
affiliation: OrthoCarolina Research Institute, Inc.
name: Glenn Gaston, MD
role: PRINCIPAL_INVESTIGATOR
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