An interventional study of Targeted Brain Rehabilitation in Phantom Limb Pain After Amputation, sponsored by OrthoCarolina Research Institute, Inc.. Enrolling by invitation at 1 site in United States. Open to participants aged 13 Years and older. Per ClinicalTrials.gov, last updated 2026-04-06.
Sponsored by OrthoCarolina Research Institute, Inc. · Not applicable, Interventional, and Treatment
This prospective study seeks to evaluate the effectiveness of prophylactic Targeted Brain Rehabilitation (TBR) in preventing or reducing Phantom Limb Pain (PLP).
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's planned enrollment of 50 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →OrthoCarolina Research Institute, Inc. is the lead sponsor of 35 studies on the registry; 6 are open to participants now.
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Exclusion Criteria:
The control group will be any patients, 13 years old or older, who underwent major amputation with Dr. Gaston and Dr. Loeffler in 12-24 months before this trial started.
The treatment group will be any patients, 13 years of age or older, who undergo major amputation with Dr. Gaston and Dr. Loeffler for 12-24 months after the start of the study.
Other: Targeted Brain Rehabilitation
Patients will be given a virtual reality headset that is pre-loaded with the targeted brain rehabilitation (TBR) software at the time of their major amputation. The Virtual Reality (VR) environment will consist of a high-fidelity virtual representation of the participant's phantom limb. Participants will use a mounted head display (MHD) to interact with a virtual avatar, with the phantom limb represented as a realistic 3D limb model matching the remaining anatomy and skin tone. The VR system will be set up either in the clinic or at the participant's home, depending on individual circumstances and preferences. The VR protocol will be standardized and include exercises designed to mimic typical occupational therapy session.
Short Form McGill Pain Questionnaire (SF-MPQ)
Assesses quality/intensity of their pain experience using descriptive words. Consists of 15 descriptors rated on an intensity scale. Includes visual analog scale (VAS). Administered to both groups. One composite score.
Time frame: Through study completion, an average of 1 year
Numeric Pain Rating Scale (NPRS)
Self-report pain on a scale of 0-10, where 0 means no pain and 10 means the worst pain imaginable
Time frame: Through study completion, an average of 1 year
Brief Pain Inventory (BPI) - Short Form
9-item questionnaire to assess pain severity and interference (two composite scores)
Time frame: Through study completion, an average of 1 year
Phantom Limb Experience Survey
Assesses presence, onset, location, character, intensity, triggers, and treatment of phantom limb sensations and phantom limb pain. Includes questions on phantom limb posture, movement, size changes, and telescoping.
Time frame: Through study completion, an average of 1 year
Phantom Limb Assessment
Assesses frequency, duration, and intensity of phantom limb pain compared to previous session. Assesses phantom limb posturing and control of phantom limb. Assesses duration of treatment effects in intervention group.
Time frame: Through study completion, an average of 1 year
Simulator Sickness Questionnaire
Assesses symptoms of simulator sickness including nausea, oculomotor problems, and disorientation. Only administered to intervention group.
Time frame: Through study completion, an average of 1 year
System Usability Scale (SUS)
Assesses subjective usability and satisfaction with the VR system. Scores range from 0 to 100, with higher scores indicating better usability.
Time frame: Through study completion, an average of 1 year
Overall VR experience and feedback survey
Supplemental questions to SUS
Time frame: Through study completion, an average of 1 year
EuroQol five-dimensional health questionnaire (EQ-5D-5L)
Assesses generic health status, quality of life, anxiety/depression
Time frame: Through study completion, an average of 1 year
Patient Health Questionnaire-9 (PHQ-9)
Objectifies and assesses degree of depression severity via questionnaire. Score ranges from 0 to 27, with higher scores indicating more severe depression.
Time frame: Through study completion, an average of 1 year
Daily Pain Log - Additional Questions
Assesses frequency and duration of phantom limb pain each day.
Time frame: Through study completion, an average of 1 year
Plan to share: No
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OrthoCarolina Research Institute, Inc.