Clinical trial NCT05296265: Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain
Official title: Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain: In-Person Treatment
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Phantom Limb Pain
Lead sponsor: Albert Einstein Healthcare Network
Sponsor class: OTHER
Collaborators: name: University of Pennsylvania
name: University of Washington
First posted: 2022-03-25
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Forty individuals with above (AKA) or below (BKA) knee amputation suffering from chronic phantom limb pain (PLP) will be recruited and will be quasi-randomly assigned to Active VR versus Distractor VR treatments in 50:50 ratio.
Primary purpose: TREATMENT

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 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.

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" (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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

1. 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)
2. History of significant or poorly controlled psychiatric disorders
3. Current significant depression or anxiety as judged by the Hospital Anxiety and Depression Scale (HADS) (Zigmond \& Snaith, 1983).
4. Current abuse of alcohol or drugs, prescription or otherwise
5. Nursing a child, pregnant, or intent to become pregnant during the study

Primary outcomes:
measure: Changes in pain intensity
timeFrame: 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
measure: Changes in pain quality
timeFrame: 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:
measure: Changes in average pain after the treatment
timeFrame: up to 4 weeks
Other outcomes:
measure: Changes in daily activities after the treatment
timeFrame: 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
measure: Changes in quality of life after the treatment
timeFrame: 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
measure: Changes in pain interference after the treatment
timeFrame: 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
measure: Changes in depression and anxiety as effect of the treatment
timeFrame: 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
measure: Changes in the pain catastrophizing after the treatment
timeFrame: 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
measure: Changes in insomnia after the treatment
timeFrame: 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
measure: Perception of VR system
timeFrame: baseline, pre-intervention
measure: Usability of each game
timeFrame: immediately after the last intervention (session 8 of the intervention);
measure: Cybersickness
timeFrame: day 1, day 8
measure: Presence in VR
timeFrame: day 1, day 8
measure: Changes in PL and PLP after the treatment
timeFrame: 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
measure: Treatment satisfaction
timeFrame: 1 week after the end of the intervention
Locations:
city: Elkins Park
country: United States
facility: Moss Rehabilitation Research Institute
state: Pennsylvania
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
city: Seattle
country: United States
facility: University of Washington-Harborview Medical Center
state: Washington
Study officials:
affiliation: Albert Einstein Healthcare Netork
name: Laurel Buxbaum, PsyD
role: PRINCIPAL_INVESTIGATOR
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