Prophylactic TBR on Phantom Limb Pain

March 31, 2026 updated by: OrthoCarolina Research Institute, Inc.

Assessing the Impact of Prophylactic Targeted Brain Rehabilitation (TBR) on Phantom Limb Pain in the Perioperative Period Following Major Amputation, A Prospective Study

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

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Charlotte, North Carolina, United States, 28207
        • OrthoCarolina Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
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.
Active Comparator: Treatment Group
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short Form McGill Pain Questionnaire (SF-MPQ)
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Numeric Pain Rating Scale (NPRS)
Time Frame: Through study completion, an average of 1 year
Self-report pain on a scale of 0-10, where 0 means no pain and 10 means the worst pain imaginable
Through study completion, an average of 1 year
Brief Pain Inventory (BPI) - Short Form
Time Frame: Through study completion, an average of 1 year
9-item questionnaire to assess pain severity and interference (two composite scores)
Through study completion, an average of 1 year
Phantom Limb Experience Survey
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Phantom Limb Assessment
Time Frame: Through study completion, an average of 1 year
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.
Through study completion, an average of 1 year
Simulator Sickness Questionnaire
Time Frame: Through study completion, an average of 1 year
Assesses symptoms of simulator sickness including nausea, oculomotor problems, and disorientation. Only administered to intervention group.
Through study completion, an average of 1 year
Overall VR experience and feedback survey
Time Frame: Through study completion, an average of 1 year
Supplemental questions to SUS
Through study completion, an average of 1 year
EuroQol five-dimensional health questionnaire (EQ-5D-5L)
Time Frame: Through study completion, an average of 1 year
Assesses generic health status, quality of life, anxiety/depression
Through study completion, an average of 1 year
Daily Pain Log - Additional Questions
Time Frame: Through study completion, an average of 1 year
Assesses frequency and duration of phantom limb pain each day.
Through study completion, an average of 1 year
System Usability Scale (SUS)
Time Frame: Through study completion, an average of 1 year
Assesses subjective usability and satisfaction with the VR system. Scores range from 0 to 100, with higher scores indicating better usability.
Through study completion, an average of 1 year
Patient Health Questionnaire-9 (PHQ-9)
Time Frame: Through study completion, an average of 1 year
Objectifies and assesses degree of depression severity via questionnaire. Score ranges from 0 to 27, with higher scores indicating more severe depression.
Through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

OrthoCarolina Research Institute, Inc.

Investigators

  • Principal Investigator: Glenn Gaston, MD, OrthoCarolina Research Institute, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2028

Study Registration Dates

First Submitted

April 24, 2025

First Submitted That Met QC Criteria

April 24, 2025

First Posted (Actual)

May 4, 2025

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 9219 (HAND141)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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