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

NCT07044323 | Recruiting DMC

• 2 other identifiers: AEHN2022-7755R01HD104158-03
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 3

Brief Summary

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).

Conditions

Phantom Pain Following Amputation of Lower Limb; Amputation

Keywords

pain; phantom limb; lower limb amputation; treatment

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Changes in average pain after the treatment

  up to 4 weeks

Other Outcomes (12)

• Changes in daily activities after the treatment

  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

  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

  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

Study Arms (1)

Home-based treatment

EXPERIMENTAL

Self-administered Active Virtual Reality treatment

Behavioral: Active Virtual Reality Treatment

Interventions

Active Virtual Reality Treatment BEHAVIORAL

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.

Home-based treatment

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Albert Einstein Healthcare Network: lead
• University of Pennsylvania: collaborator

Study Sites (3)

Jefferson Moss Rehabilitation Research Institute

Philadelphia, Pennsylvania, 19027, United States

RECRUITING

University of Pennsylvania

Philadelphia, Pennsylvania, 19122, United States

RECRUITING

University of Washington

Seattle, Washington, 98195, United States

RECRUITING

Related Publications (8)

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  PMID: 9849105 BACKGROUND

• 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.

  PMID: 11438246 BACKGROUND

• 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.

  PMID: 6880820 BACKGROUND

• 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.

  PMID: 22981809 BACKGROUND

• Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.

  PMID: 8080219 BACKGROUND

• 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.

  PMID: 8628042 BACKGROUND

• 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.

  PMID: 6869117 BACKGROUND

• Melzack R. The short-form McGill Pain Questionnaire. Pain. 1987 Aug;30(2):191-197. doi: 10.1016/0304-3959(87)91074-8.

  PMID: 3670870 BACKGROUND

MeSH Terms

Conditions

Pain; Phantom Limb

Condition Hierarchy (Ancestors)

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

Central Study Contacts

Laurel Buxbaum

CONTACT

215-663-6321; Laurel.Buxbaum@jefferson.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 23, 2025
• First Posted: June 30, 2025
• Study Start: June 16, 2025
• Primary Completion (Estimated): May 31, 2026
• Study Completion (Estimated): May 31, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Locations

US (3)