An interventional study of VR treatment for phantom limb pain in Phantom Limb Pain, sponsored by Albert Einstein Healthcare Network. Completed at 3 sites in United States. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-09-30.
Sponsored by Albert Einstein Healthcare Network · Not applicable, Interventional, and Treatment
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.
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.
163 studies on the registry are indexed under Phantom Limb; 35 are open to participants now.
This study's enrollment of 46 is above the median of 30 across 125 interventional studies indexed under Phantom Limb.
Browse Phantom Limb studies →Albert Einstein Healthcare Network is the lead sponsor of 63 studies on the registry; 6 are open to participants now.
Of its 6 completed or terminated interventional studies of FDA-regulated products, 3 (50%) have results posted.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects assigned to the Active VR treatment began by selecting an avatar, with features such as gender and skin color that could be chosen according to preference. During treatment, they participated in a variety of games and activities developed and used by our teams including Kick, Dog Food, Quest for Fire, Chess, Checkers, Sudoku, and surfing the internet. Subjects had substantial flexibility to select games according to their interests but were required to spend at least 30 minutes in each session in games that required forceful, large-amplitude movements of the amputated lower limb (e.g., Quest for Fire, Kick).
Behavioral: VR treatment for phantom limb pain
Subjects assigned to the Distractor VR treatment participated in the REAL i-Series immersive VR experience (REAL system), which had been demonstrated to reduce pain in several studies but lacked the hypothesized "active ingredients" of our Active VR treatment (visual and auditory feedback of movement of an extrapolated amputated limb). Subjects navigated through pleasant and relaxing VR environments; they did not see any rendering of their body and made no movements with their legs.
Behavioral: VR treatment for phantom limb pain
8 twice-weekly interventions of virtual reality treatment focused on reducing phantom limb pain.
Changes in Pain Intensity
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)
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Changes in Pain Quality
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Changes in Average Pain
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).
Time frame: 1st treatment versus 8th treatment (4 weeks)
Changes in Daily Activities
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Changes in Quality of Life
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).
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Changes in Pain Interference
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks
Changes in Depression and Anxiety
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Changes in Pain Catastrophizing
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Changes in Insomnia
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks.
Acceptance of VR System
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).
Time frame: Baseline
Usability of the Treatment
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.
Time frame: immediately after the last intervention (session 8 of the intervention), an average of 4 weeks
Cybersickness
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.
Time frame: 1st (week 1) and 8th (week 4) treatment sessions
Presence in VR
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
Time frame: 1st (week 1) and 8th (week 4) treatment sessions.
Changes in Pain at Its Worst
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.
Time frame: Baseline versus immediately post-intervention at 4 weeks
Treatment Satisfaction
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)
Time frame: 1 week after the end of the intervention, an average of 5 weeks
Participants were recruited over a period of approximately 3 years at one of our study sites. Recruitment methods included mail, email, and/or telephone contact with potential participants identified through our databases; monthly invitation emails to patients listed in the Jefferson database; advertisements on the Amputee Coalition website and Facebook amputee groups; outreach through amputee support group meetings; and distribution of flyers at prosthetic clinics.
| Milestone | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Started | 25 | 18 |
| Completed | 21 | 15 |
| Not completed | 4 | 3 |
| Withdrew: Lost to follow-up | 4 | 3 |
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)
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Pain Intensity | -1.42 ± 0.52 | -.29 ± 0.73 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Pain Quality | -6.45 ± 2.83 | -2.46 ± 2.15 |
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).
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Average Pain | -2.68 ± 0.44 | -1.81 ± 0.83 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Daily Activities | 0.7 ± 0.24 | -1.47 ± 0.33 |
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).
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| mental scale | 2.3 ± 0.95 | 7.9 ± 1.25 |
| physical scale | -0.53 ± 0.55 | 4.04 ± 1.16 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Pain Interference | -9.02 ± 1.09 | -0.29 ± 1.47 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Depression scale | -0.2 ± 0.11 | 0.53 ± 0.18 |
| Anxiety scale | -0.95 ± 0.13 | -0.53 ± 0.22 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Pain Catastrophizing | -1.6 ± 0.51 | -0.4 ± 0.82 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Insomnia | -2.2 ± 0.4 | -1.67 ± 0.53 |
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).
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Acceptance of VR System | 24 ± 9.5 | 29 ± 7.5 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Usability of the Treatment | 34.4 ± 14.6 | 30.6 ± 3.3 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| session 1 | 0.17 ± 0.20 | 0.07 ± 0.11 |
| session 8 | 0.18 ± 0.20 | 0.16 ± 0.24 |
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
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| session 1 | 4.79 ± 1.24 | 4.77 ± 1.16 |
| session 8 | 4.65 ± 1.53 | 4.72 ± 1.10 |
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.
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Changes in Pain at Its Worst | -2.18 ± 0.67 | -0.83 ± 0.55 |
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)
| score on a scale | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| Treatment Satisfaction | 8.08 ± 3.08 | 8.94 ± 1.48 |
Collected over from enrollment until end of follow-up, up to 12 weeks. Non-serious events are listed at a 4% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active VR Treatment | 0/21 (0%) | 0/21 (0%) | 1/21 (4.8%) |
| Distractor VR Treatment | 1/15 (6.7%) | 1/15 (6.7%) | 1/15 (6.7%) |
| Event | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| deathGeneral disorders | 0/21 | 1/15 |
| Event | Active VR Treatment | Distractor VR Treatment |
|---|---|---|
| cybersicknessGeneral disorders | 1/21 | 1/15 |
The present table only reports participants who completed the treatment.
| Age, Continuous(years) | Active VR Treatment | Distractor VR Treatment | Total |
|---|---|---|---|
| Mean | 59 ± 13.9 | 59 ± 10.7 | 59 ± 12.5 |
| Sex: Female, Male(Participants) | Active VR Treatment | Distractor VR Treatment | Total |
|---|---|---|---|
| Female | 10 | 3 | 13 |
| Male | 11 | 12 | 23 |
| Race (NIH/OMB)(Participants) | Active VR Treatment | Distractor VR Treatment | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 1 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 10 | 6 | 16 |
| White | 11 | 7 | 18 |
| More than one race | 0 | 1 | 1 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active VR Treatment | Distractor VR Treatment | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 1 | 1 |
| Not Hispanic or Latino | 21 | 14 | 35 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Pain Intensity score on VAS(score on a scale) | Active VR Treatment | Distractor VR Treatment | Total |
|---|---|---|---|
| Mean | 2.3 ± 2.7 | 2.4 ± 2.6 | 2.3 ± 2.7 |
| Pain quality at baseline(score on a scale) | Active VR Treatment | Distractor VR Treatment | Total |
|---|---|---|---|
| Mean | 20.7 ± 9.1 | 19.2 ± 6.4 | 19.9 ± 7.7 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — After de-identification, individual participant data to be shared included descriptors of clinical status (e.g., time since amputation, level of amputation), background test battery results, and outcome measures results.
Supporting information: Study protocol
Time frame: Immediately following publication. No end date.
Access criteria: Researchers who provide a sound rationale.
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