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Completed

NCT Number: NCT05296265

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

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 proposed work will contrast the efficacy of two virtual reality treatments for phantom limb pain: a 'Distractor' and an Active VR treatment. In the Distractor treatment, participants are engaged in a visually immersive virtual reality experience that does not require leg movements (REAL i-Series® immersive VR experience). In the Active VR treatment, subjects play a series of VR games using the virtual rendering of both legs.

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Key information

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania, United States

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About this study

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" (Weeks et al., 2010). 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 (Weeks et al., 2010).

The investigators recently completed a proof-of-concept study (Ambron et al., 2021) in which eight subjects with below knee amputations (BKA) underwent two virtual reality (VR) treatments for PLP. In an 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 an electromagnetic system using leg sensors (trackSTAR, Ascension Technologies Inc), and the program generated an image of the missing lower leg, visible as a first-person avatar. This treatment was contrasted with a "Distractor" treatment, in which participants were engaged in a visually immersive virtual reality experience that did not require leg movements (Cool!TM). Both treatments were associated with significant reductions in pain intensity, but the Active VR treatment was also associated with reductions in pain interference, depression, and anxiety.

The specific aims of the current study are (i) to replicate our prior observations of efficacy of VR treatment in a larger sample of individuals with BKA; (ii) to test VR therapy in patients with above knee amputations; (iii) to compare 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18 - 100 years
  • 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 greater
  • 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
  • Current significant depression or anxiety as judged by the Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983).
  • Current abuse of alcohol or drugs, prescription or otherwise
  • Nursing a child, pregnant, or intent to become pregnant during the study

Treatment and study plan

VR treatment for phantom limb pain

Behavioral

8 twice-weekly interventions of virtual reality treatment focused on reducing phantom limb pain.

Primary outcomes

  1. Changes in Pain Intensity

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    Visual Analogue Scale (VAS) of McGill Short Form Questionnaire (Melzack, 1987); 0 minimum score - 10 maximum score; higher scores indicate higher level of pain (worse outcome)

  2. Changes in Pain Quality

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    McGill Short Form Questionnaire (Melzack, 1987): a series of 4-point scales (0 none - 3 severe) assessing the intensity of 15 qualitative characteristics of pain (e.g., throbbing, shooting, cramping, etc.), where higher scores are worse (more severe). For every participant we computed the total pain score (maximum 45 points indicating severe pain). Then, we computed the difference in the total scores between time points (e.g. post treatment vs baseline). Therefore, negative scores indicate improvement in pain qualitative characteristics.

Secondary outcomes

  1. Changes in Average Pain

    Time frame: 1st treatment versus 8th treatment (4 weeks)

    Difference between 8th and 1st treatment session on scaled score measuring "average pain intensity since the previous intervention" on an 11-point numerical rating pain scale; (Scale = 0 - minimum score/no pain to 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome).

Other outcomes

  1. Changes in Daily Activities

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    The Frenchay Activities Index (FAI) (Holbrook et al., 1983):1983): a scale measuring the physical function and daily activity associated with quality of life in people with amputation. Scale = 0 minimum score to 45 maximum score; higher scores indicate more daily activities (better outcome). We report the average difference between post-intervention (after 4 weeks) and pre-intervention.

  2. Changes in Quality of Life

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    The 12-Item Short Form Health Survey (SF-12) (Ware et al., 1996): a measure of quality of life and functional capacity that has been validated in patients with amputation and phantom limb pain. Scale = 0 minimum score to 100 maximum score. Higher scores indicate poorer physical and mental health (worse outcome).

  3. Changes in Pain Interference

    Time frame: Baseline versus immediately post-intervention at 4 weeks

    The Pain Interference Scale from the Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994): A scale measuring the degree to which pain interferes with daily activities using a 0-10 numeric rating. Scale = 0 minimum score to 10 maximum score. Higher scores indicate greater pain interference (worse outcome). We report the average difference between post-intervention (after 4 weeks) and pre-intervention.

  4. Changes in Depression and Anxiety

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983): This is a 14- item measure with subscales assessing depressive and anxiety symptoms. For each subscale. range = 0 minimum score to 42 maximum score. Higher scores indicate more depression and/or anxiety (worse outcome). We report average differences on the anxiety scale and the depression scales between post-intervention (after 4 weeks) and pre-intervention.

  5. Changes in Pain Catastrophizing

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    The 13-item Pain Catastrophizing Scale (Sullivan et al., 1995): this scale investigates pain catastrophizing, which has been associated with pain severity and disability after amputation. Score range = 0-52; Higher scores indicate higher tendency to catastrophize (worse outcome). We report the average difference between post-intervention (after 4 weeks) and pre-intervention.

  6. Changes in Insomnia

    Time frame: Baseline versus immediately post-intervention at 4 weeks.

    Insomnia Severity Index (Bastien et al., 2001): a 7-point scale that measures insomnia, a symptom associated with phantom limb pain. Score range = 0-28; higher scores indicate more insomnia (worse outcome). We report the average difference between post-intervention (after 4 weeks) and pre-intervention.

  7. Acceptance of VR System

    Time frame: Baseline

    Technology Acceptance Scale (Morris et al., 1997): this is a 7-point scale that measures level of acceptance of the VR system. 0 minimum score - 133 maximum score; higher scores indicate low level of acceptance (worse score).

  8. Usability of the Treatment

    Time frame: immediately after the last intervention (session 8 of the intervention), an average of 4 weeks

    System Usability Scale (SUS) (Brooke, 1996); Scale measuring the usability of the each game; minimum score 10 - maximum score 50. Higher scores indicate less usability (worse outcome). For the distractor treatment, participants rated the overall experience; for the active treatment, the average of the two games was computed for each participants.

  9. Cybersickness

    Time frame: 1st (week 1) and 8th (week 4) treatment sessions

    Simulator Sickness Questionnaire - SSQ (Kennedy et al., 1993): 4 points (0 - none; 3 - severe) scale assessing the severity of 16 cybersickness motion sickness symptoms, like nausea or dizziness. We computed the average score across items.

  10. Presence in VR

    Time frame: 1st (week 1) and 8th (week 4) treatment sessions.

    Brief Slater-Usoh-Steed Presence Questionnaire (Usoh et al., 2000; Slater et al., 1998; 1994). 0 minimum score - 42 maximum score. Higher scores indicate more presence in the VR (better outcome

  11. Changes in Pain at Its Worst

    Time frame: Baseline versus immediately post-intervention at 4 weeks

    The Modified Limb Deficiency and Phantom Limb Questionnaire (Goller et al., 2013): a questionnaire and visual analog scale assessing prosthesis usage, phantom limb experiences, and pain severity. The outcome measure used was the score on the visual analogue scale assessing pain severity at its worst (Scale = 0 no pain to 10 unbearable pain). We report the average score difference between post-intervention (after 4 weeks) and pre-intervention.

  12. Treatment Satisfaction

    Time frame: 1 week after the end of the intervention, an average of 5 weeks

    Visual analogue scale that evaluates treatment satisfaction (Robinson et al., 2004; Smith et al., 2005); 0 minimum score - 10 maximum score; Higher scores indicate more treatment satisfaction (better outcome)

Sponsors and collaborators

Lead sponsor

Albert Einstein Healthcare Network

Other

Collaborators

  • Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
  • University of Pennsylvania
  • University of Washington

Registry information

Official study title

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain: In-Person Treatment

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Mar 25, 2022
Registry last updated
Sep 9, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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