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

Overview

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.

Interventions

• 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 wi

Primary outcome measures

• Short Form McGill Pain Questionnaire (SF-MPQ) [Time frame: Through study completion, an average of 1 year]

Secondary outcome measures (10)

• Numeric Pain Rating Scale (NPRS) [Time frame: Through study completion, an average of 1 year]
• Brief Pain Inventory (BPI) - Short Form [Time frame: Through study completion, an average of 1 year]
• Phantom Limb Experience Survey [Time frame: Through study completion, an average of 1 year]
• Phantom Limb Assessment [Time frame: Through study completion, an average of 1 year]
• Simulator Sickness Questionnaire [Time frame: Through study completion, an average of 1 year]
• System Usability Scale (SUS) [Time frame: Through study completion, an average of 1 year]
• Overall VR experience and feedback survey [Time frame: 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]
• Patient Health Questionnaire-9 (PHQ-9) [Time frame: Through study completion, an average of 1 year]
• Daily Pain Log - Additional Questions [Time frame: Through study completion, an average of 1 year]

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)

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Non-randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Treatment

Study locations

United States · 1 center

• OrthoCarolina Research Institute — Charlotte

Publications

• Rutledge T, Velez D, Depp C, McQuaid JR, Wong G, Jones RCW, Atkinson JH, Giap B, Quan A, Giap H. A Virtual Reality Intervention for the Treatment of Phantom Limb Pain: Development and Feasibility Results. Pain Med. 2019 Oct 1;20(10):2051-2059. doi: 10.1093/pm/pnz121. PMID 31165893
• Rothgangel, A. S., Braun, S., Schulz, R. J., Kraemer, M., de Witte, L., Beurskens, A., & Smeets, R. J. (2018). The PACT trial: patient centered telerehabilitation program for post-acute coronary artery disease patients. A prospective, multicenter, randomized controlled trial. Journal of Clinical Medicine, 7(10), 355.
• Rothgangel A, Braun S, Winkens B, Beurskens A, Smeets R. Traditional and augmented reality mirror therapy for patients with chronic phantom limb pain (PACT study): results of a three-group, multicentre single-blind randomized controlled trial. Clin Rehabil. 2018 Dec;32(12):1591-1608. doi: 10.1177/0269215518785948. Epub 2018 Jul 16. PMID 30012007
• MacIver K, Lloyd DM, Kelly S, Roberts N, Nurmikko T. Phantom limb pain, cortical reorganization and the therapeutic effect of mental imagery. Brain. 2008 Aug;131(Pt 8):2181-91. doi: 10.1093/brain/awn124. Epub 2008 Jun 20. PMID 18567624
• Wand BM, Parkitny L, O'Connell NE, Luomajoki H, McAuley JH, Thacker M, Moseley GL. Cortical changes in chronic low back pain: current state of the art and implications for clinical practice. Man Ther. 2011 Feb;16(1):15-20. doi: 10.1016/j.math.2010.06.008. Epub 2010 Jul 23. PMID 20655796
• Ambron E, Miller A, Kuchenbecker KJ, Buxbaum LJ, Coslett HB. Immersive Low-Cost Virtual Reality Treatment for Phantom Limb Pain: Evidence from Two Cases. Front Neurol. 2018 Feb 19;9:67. doi: 10.3389/fneur.2018.00067. eCollection 2018. PMID 29515513
• Vassantachart AY, Yeo E, Chau B. Virtual and Augmented Reality-based Treatments for Phantom Limb Pain: A Systematic Review. Innov Clin Neurosci. 2022 Oct-Dec;19(10-12):48-57. PMID 36591552
• Barbin J, Seetha V, Casillas JM, Paysant J, Perennou D. The effects of mirror therapy on pain and motor control of phantom limb in amputees: A systematic review. Ann Phys Rehabil Med. 2016 Sep;59(4):270-5. doi: 10.1016/j.rehab.2016.04.001. Epub 2016 May 30. PMID 27256539

Identifiers

NCT: NCT06956508 · 9219 (HAND141)

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗