Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment (PLP Home-Based)

After amputation of an arm or leg, up to 90% of subjects experience a "phantom limb", a phenomenon characterized by persistent feelings of the missing limb. Many subjects with a phantom limb experience intense pain in the missing extremity that is often poorly responsive to medications or other interventions. The study will explore the feasibility and efficacy of a home-based, active VR treatment for phantom limb pain (PLP).

Study Overview

• Status: Recruiting
• Conditions: Amputation; Phantom Pain Following Amputation of Lower Limb
• Intervention / Treatment: Behavioral: Active Virtual Reality Treatment

Detailed Description

Almost 2 million people in the US have had an amputation and up to 90% of people with limb amputation experience the persistent sensation of the missing extremity, a phenomenon known as a "phantom limb"Additionally, a significant proportion of individuals with a phantom limb - up to 85% in some studies - experience persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (hereafter PLP). Although existing therapies provide pain relief in some cases, there is widespread agreement that current approaches fall short of bringing relief to most individuals with PLP

The investigators recently completed the in-person part of the study in which they compared the efficacy of Active VR treatment to Distractor VR treatment for PLP on measures of pain as well as psychological health and quality of life.

In the Active VR treatment, subjects played a variety of active games requiring leg movements while receiving high-quality visual feedback of the missing lower leg. Feedback about leg position was provided via the VR headset controller, and the program generated an image of the missing lower leg, visible as a first-person avatar. The "Distractor" treatment was the REAL i-Series® immersive VR experience: subjects navigated through a pleasant VR environment, without seeing any rendering of their body and making no movements with their legs. The results of the in-person study showed superior efficacy in reducing pain intensity of the Active Treatment as compared to the Distractor treatment.

The specific aim of the current study is to assess the feasibility and efficacy of a home-based, active VR treatment for PLP.

• Study Type: Interventional
• Enrollment (Estimated): 44
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Laurel Buxbaum; Phone Number: 215-663-6321; Email: Laurel.Buxbaum@jefferson.edu

Study Locations

• United States
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19027
      • Recruiting
      • Jefferson Moss Rehabilitation Research Institute
      • Contact: Rand Williamson; Phone Number: 215-663-6321; Email: Rand.Williamson@jefferson.edu
    • Philadelphia, Pennsylvania, United States, 19122
      • Recruiting
      • University of Pennsylvania
      • Contact: Elisabetta Ambron; Phone Number: 215-573-4336; Email: eambron@pennmedicine.upenn.edu
  • Washington
    • Seattle, Washington, United States, 98195
      • Recruiting
      • University of Washington
      • Contact: Jing-Sheng Li; Phone Number: 215-663-6321; Email: jsli@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age 18 -100
• Capacity to provide Informed Consent
• Unilateral above or below knee amputation more than 3 months prior to enrollment
• Absence of cognitive impairment, operationally defined as a Montreal Cognitive Assessment score of 18 or greater1.
• Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10.

Exclusion Criteria:

• History of significant medical or neurological disorder such as stroke or moderate to severe traumatic brain injury (operationally defined as loss of consciousness for more than 30 minutes)
• History of significant or poorly controlled psychiatric disorders
• Substantial depression or anxiety affecting their ability to perform tasks necessary for the study.
• Current abuse of alcohol or drugs, prescription or otherwise
• Nursing a child, pregnant, or intent to become pregnant during the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Home-based treatment; Self-administered Active Virtual Reality treatment	Behavioral: Active Virtual Reality Treatment; The self-administered active VR treatment will consist of 8 twice-weekly sessions, each approximately 1 hour in duration, during which subjects will participate in a variety of Virtual Reality active games that require leg movements while receiving high-quality visual feedback of the missing lower leg.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in pain intensity	the change in phantom limb pain score pre and post each VR intervention, at baseline, after the VR intervention and in the follow-up sessions as assessed using an 11-point numerical rating pain scale (0 - minimum score/no pain; 10 maximum score/pain as bad as you can imagine) assessing the current PLP level.	pre each intervention (8 sessions); immediately after each intervention (8 session); baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention.
Changes in pain quality of the McGill Short Form Questionnaire	The change in the phantom limb pain quality between baseline, post-intervention, and follow-up sessions using McGill Short Form Questionnaire that measures the characteristics of pain (e.g., throbbing, etc.) using a 4-point rating pain scale (0 - minimum score - none: better outcome /4 maximum score - severe: worse outcome).	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in average pain after the treatment	average pain intensity since the previous intervention on an 11-point numerical rating pain scale; (0 - minimum score/no pain; 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome)	up to 4 weeks

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perception of VR system	Technology Acceptance Scale (Morris et al., 1997): this is a 7-point scale that measure level of acceptance of the VR system. 0 minimum score - 133 maximum score; higher scores indicate low level of acceptance (worse score)	baseline, pre-intervention
Changes in daily activities after the treatment	The Frenchay Activities Index (FAI): a scale measuring the physical function and daily activity that has excellent reliability in subjects with lower-limb amputation in predicting quality of life. 0 minimum score - 45 maximum score; higher scores indicate more daily activities (better outcome).	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Changes in quality of life after the treatment	The 12-Item Short Form Health Survey (SF-12): a brief measure of quality of life and functional capacity that has been validated in patients with amputation and PLP. 0 minimum score - 100 maximum score. Higher scores indicate lower physical and mental health (worse outcome).	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Changes in pain interference after the treatment	The Pain Interference Scale from the Brief Pain Inventory (BPI): this assesses the degree to which pain interferes with daily activities using a 0-10 numeric rating scale. 0 minimum score - 10 maximum score. Higher scores indicate higher pain interference (worse outcome).	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Changes in depression and anxiety as effect of the treatment	The Hospital Anxiety and Depression Scale (HADS): the HADS is a 14- item measure assessing both depressive and anxiety symptoms. In addition to providing separate scores for anxiety and depression, the HADS also provides a measure of global negative affect. 0 minimum score - 42 maximum score. Higher scores indicate more depression and anxiety (worse outcome)	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Changes in the pain catastrophizing after the treatment	The 13-item Pain Catastrophizing Scale: this scale investigates pain catastrophizing, which has been highly associated with pain severity and disability after amputation. 0 minimum score -52; Higher scores indicate higher tendency to catastrophizing (worse outcome)	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Changes in insomnia after the treatment	Insomnia Severity Index: this is a 7-point scale that measure insomnia, a symptom associated with PLP. 0 minimum score - 28 maximum score; higher scores indicate more insomnia (worse outcome)	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Usability of each game	System Usability Scale (SUS): Scale measuring the usability of each game; minimum score 10 - maximum score 50. Higher scores indicate less usability (worse outcome).	immediately after the last intervention (session 8 of the intervention);
Simulator Sickness Questionnaire	Simulator Sickness Questionnaire, which test for the presence of symptoms of cybersickness (e.g., general discomfort) on a 4-point numerical rating scale (0 - minimum score/no symptom; 4 maximum score/severe symptom)	day 1, day 8
Presence in VR	Brief Slater-Usoh-Steed Presence Questionnaire. 7 minimum score - 42 maximum score. Higher scores indicate more presence in the VR (better outcome)	day 1, day 8
Changes in Phantom Limb and Phantom Limb Pain after the treatment	The Modified Limb Deficiency and Phantom Limb Questionnaire: this questionnaire assesses the usage of prosthesis (yes/no) and non-painful phantom limb experiences (presence/absence), including perceived position (e.g., presence/absence of telescoping) and ability to move the phantom (yes/no).	baseline, pre-intervention; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Treatment satisfaction	visual analogue scale that evaluates treatment satisfaction; 0 minimum score - 10 maximum score; Higher scores indicate more treatment satisfaction (better outcome)	1 week after the end of the intervention

Collaborators and Investigators

• Sponsor: Albert Einstein Healthcare Network
• Collaborators: University of Pennsylvania

Publications and helpful links

General Publications

• Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
• Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.
• Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
• Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
• Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.

Study record dates

Study Major Dates

• Study Start (Actual): June 16, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026

Study Registration Dates

• First Submitted: June 23, 2025
• First Submitted That Met QC Criteria: June 23, 2025
• First Posted (Actual): June 30, 2025

Study Record Updates

• Last Update Posted (Actual): August 8, 2025
• Last Update Submitted That Met QC Criteria: August 7, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: treatment; pain; lower limb amputation; phantom limb
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Nervous System Diseases; Postoperative Complications; Pathologic Processes; Neurobehavioral Manifestations; Perceptual Disorders; Pain, Postoperative; Phantom Limb
• Other Study ID Numbers: AEHN2022-775; 5R01HD104158-03 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No