Prophylactic TBR on Phantom Limb Pain

NCT06956508 | Not Yet Recruiting DMC

• 1 other identifier: HAND141
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Phantom Limb Pain After Amputation

Keywords

Phantom Limb Pain; Targeted Brain Rehabilitation; VR; Virtual Reality

Outcome Measures

Primary Outcomes (1)

• 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.

  Through study completion, an average of 1 year

Secondary Outcomes (10)

• Numeric Pain Rating Scale (NPRS)

  Through study completion, an average of 1 year

• Brief Pain Inventory (BPI) - Short Form

  Through study completion, an average of 1 year

• Phantom Limb Experience Survey

  Through study completion, an average of 1 year

• Phantom Limb Assessment

  Through study completion, an average of 1 year

• Simulator Sickness Questionnaire

  Through study completion, an average of 1 year

Study Arms (2)

Control Group

NO INTERVENTION

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.

Treatment Group

ACTIVE COMPARATOR

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

Interventions

Targeted Brain Rehabilitation OTHER

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.

Treatment Group

Eligibility Criteria

• Age: 13 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• + 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• OrthoCarolina Research Institute, Inc.: lead

Study Sites (1)

OrthoCarolina Research Institute

Charlotte, North Carolina, 28207, United States

Location

Related Publications (13)

• 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 BACKGROUND

• 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.

  BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

• Alviar MJ, Hale T, Dungca M. Pharmacologic interventions for treating phantom limb pain. Cochrane Database Syst Rev. 2016 Oct 14;10(10):CD006380. doi: 10.1002/14651858.CD006380.pub3.

  PMID: 27737513 BACKGROUND

• Von Korff MR. Long-term use of opioids for complex chronic pain. Best Pract Res Clin Rheumatol. 2013 Oct;27(5):663-72. doi: 10.1016/j.berh.2013.09.011. Epub 2013 Oct 5.

  PMID: 24315147 BACKGROUND

• Ziegler-Graham K, MacKenzie EJ, Ephraim PL, Travison TG, Brookmeyer R. Estimating the prevalence of limb loss in the United States: 2005 to 2050. Arch Phys Med Rehabil. 2008 Mar;89(3):422-9. doi: 10.1016/j.apmr.2007.11.005.

  PMID: 18295618 BACKGROUND

• Padovani MT, Martins MR, Venancio A, Forni JE. Anxiety, depression and quality of life in individuals with phantom limb pain. Acta Ortop Bras. 2015 Mar-Apr;23(2):107-10. doi: 10.1590/1413-78522015230200990.

  PMID: 27069411 BACKGROUND

• van der Schans CP, Geertzen JH, Schoppen T, Dijkstra PU. Phantom pain and health-related quality of life in lower limb amputees. J Pain Symptom Manage. 2002 Oct;24(4):429-36. doi: 10.1016/s0885-3924(02)00511-0.

  PMID: 12505212 BACKGROUND

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Study Officials

• Glenn Gaston, MD

  OrthoCarolina Research Institute, Inc.

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Caleb Michalek, BS

CONTACT

7043233698; caleb.michalek@orthocarolina.com

Joshua Steinke, BS

CONTACT

7043232557; joshua.steinke@orthocarolina.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All Control Group patients will be retrospective subjects. Treatment Groups will be a single intervention enrolled prospectively.

Study Record Dates

• First Submitted: April 24, 2025
• First Posted: May 4, 2025
• Study Start: August 15, 2025
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2028
• Last Updated: August 3, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)