Clinical trial NCT03338842: Virtual Reality Treatment for Phantom Limb Pain
Official title: Virtual Reality Treatment for Phantom Limb Pain
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Lower Limb Amputation Above Knee (Injury)
Lower Limb Amputation Below Knee (Injury)
Phantom Limb Pain
Lead sponsor: University of Pennsylvania
Sponsor class: OTHER
Collaborators: name: Moss Rehabilitation Research Institute
First posted: 2017-11-09
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: In the first phase (A), subjects will receive the Distraction VR treatment during 5, 6, or 7 one-hour-long sessions occurring twice weekly. After the A phase, the remaining sessions (B phase) will consist of Lower-Limb VR treatment. This number includes a mean of 6 (range 5-7) phase A sessions and mean of 11 (range 10-12) phase B sessions.
Primary purpose: TREATMENT

Brief summary: Patients with limb amputations experience the sensation of the missing extremity, which is sometimes coupled with a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP). This study will test the use of virtual reality (VR) training as a possible treatment of PLP.

Detailed description: Approximately 90% of patients with limb amputations experience the persistent sensation of the missing extremity, a phenomenon known as phantom limb (PL). Most patients with PL also experience a persistent and debilitating pain in the missing limb, a condition known as phantom limb pain (PLP).PLP is often attributed to a disruption of the primary sensory-motor representation, generating "noise" in the representation of the missing extremity, manifesting as pain. If loss of sensory feedback causes degradation of the these cortices, interventions that provide visual feedback about the missing extremity might fine-tune the primary sensory-motor cortices, thereby reducing pain. Within this framework, the present study explores the use of virtual reality (VR) training as a possible treatment of PLP. Twenty-five subjects with lower-limb amputation and chronic PLP will undergo a Virtual Reality (VR) treatment (17 one-hour sessions) consisting in two phases: a Distraction VR phase (5-7 sessions) in which they will explore VR environments using a joystick and a Lower-Limb VR treatment phase (10-12 sessions) in which they will participate in a variety of games and activities using their VR lower-limbs. A comprehensive battery for the assessment of the characteristics, intensity and the daily-life implication of PLP will be presented before and after the treatment and in three follow up testing sessions (1,4, 8 weeks). Furthermore, pain intensity will be assessed before and after each VR session. A dramatic reduction of PLP is expected after the VR treatment and that these beneficial effects remain stable in time.

Eligibility criteria: Inclusion Criteria:

* Subjects will have undergone amputation of one leg (either above or below the knee) at least 4 months before the enrollment in the study;
* Will have chronic pain in the phantom limb:

Exclusion Criteria:

* History of stroke or traumatic brain injury;
* Major active psychiatric illness that may interfere with required study procedures or treatments as determined by the PI on the study, who is a behavioral neurologist;
* Subjects with major medical illness that would be expected to interfere with their ability to complete the study will be excluded.
* Subjects with implanted electronic devices.

Primary outcomes:
measure: Changes in the Brief Pain Inventory
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
measure: Changes in the McGill Pain Questionnaire
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
measure: Changes in the Frenchay Activities Index
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
measure: Changes in the12-Item Short Form Health Survey
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
measure: Changes in the Hospital Anxiety and Depression Scale
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Secondary outcomes:
measure: Changes in the Limb deficiency and Phantom Limb questionnaire.
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
measure: Changes in the 13-item Pain Catastrophizing scale
timeFrame: Pre and post Phase 1; Pre and post Phase 2; at 1, 4 and 8 weeks
Other outcomes:
Locations:
city: Philadelphia
country: United States
facility: University of Pennsylvania
state: Pennsylvania
Study officials:
affiliation: hbc@mail.med.upenn.edu
name: Branch Coslett
role: PRINCIPAL_INVESTIGATOR
affiliation: Lbuxbaum@einstein.edu
name: Laurel Buxbaum
role: PRINCIPAL_INVESTIGATOR
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