Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain.Home-Based Treatment
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-100
SponsorAlbert Einstein Healthcare Network
About this trial
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).
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
Active Virtual Reality Treatment
BehavioralThe 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.
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: Home-based treatmentExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
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.2
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).
Time frame
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 interventionSecondary outcomes
1
Changes in average pain after the treatment
average pain intensity since the previous intervention on an 11-point numerical rating pain scale; (0 - minimum score/no pain; 10 maximum score/pain as bad as participants can imagine); higher scores indicate higher level of pain (worse outcome)
Time frame
up to 4 weeksOther outcomes
1
Changes in daily activities after the treatment
The Frenchay Activities Index (FAI): a scale measuring the physical function and daily activity that has excellent reliability in subjects with lower-limb amputation in predicting quality of life. 0 minimum score - 45 maximum score; higher scores indicate more daily activities (better outcome).
Time frame
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 intervention2
Changes in quality of life after the treatment
The 12-Item Short Form Health Survey (SF-12): a brief measure of quality of life and functional capacity that has been validated in patients with amputation and PLP. 0 minimum score - 100 maximum score. Higher scores indicate lower physical and mental health (worse outcome).
Time frame
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 intervention3
Changes in pain interference after the treatment
The Pain Interference Scale from the Brief Pain Inventory (BPI): this assesses the degree to which pain interferes with daily activities using a 0-10 numeric rating scale. 0 minimum score - 10 maximum score. Higher scores indicate higher pain interference (worse outcome).
Time frame
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 intervention4
Changes in depression and anxiety as effect of the treatment
The Hospital Anxiety and Depression Scale (HADS): the HADS is a 14- item measure assessing both depressive and anxiety symptoms. In addition to providing separate scores for anxiety and depression, the HADS also provides a measure of global negative affect. 0 minimum score - 42 maximum score. Higher scores indicate more depression and anxiety (worse outcome)
Time frame
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 interventionSponsors and contacts
Click on the lead sponsor to view all of their trials.
Albert Einstein Healthcare Network
Lead sponsor
University of Pennsylvania
Collaborator
Source ClinicalTrials.gov