VR treatment for phantom limb pain
Behavioral8 twice-weekly interventions of 1 hour; baseline, pre-intervention; immediately after the end of the in intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
NCT Number: NCT05296265
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.
Looking for future studies?
Notify Me18 year–100 year
All sexes
Interventional
Not applicable
Moss Rehabilitation Research Institute, Elkins Park, Pennsylvania, United States
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
8 twice-weekly interventions of 1 hour; baseline, pre-intervention; immediately after the end of the in intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
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
Visual Analogue Scale 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, 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
McGill Short Form Questionnaire (Melzack, 1987): a series of 4-point scales assessing 15 characteristics of pain (e.g., throbbing, shooting, cramping, etc.). It generates separate scores for Sensory, Affective, and Total pain (maximum 78 points), and correlates strongly with the well-known long form of the questionnaire
Time frame: up to 4 weeks
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: 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
The Frenchay Activities Index (FAI) (Holbrook et al., 1983):1983): a scale measuring the physical function and daily activity that has excellent reliability in subjects with lower-limb amputation in predicting quality of life (Asono et al., 2008). 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 intervention
The 12-Item Short Form Health Survey (SF-12) (Ware et al., 1996): a brief measure of quality of life and functional capacity that has been validated in patients with amputation and PLP (Padovani et al., 2015; Chen et al., 2012; Pape et al., 2010). 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 intervention
The Pain Interference Scale from the Brief Pain Inventory (BPI) (Cleeland & Ryan, 1994): 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 intervention
The Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983):1983): 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 intervention
The 13-item Pain Catastrophizing Scale (Sullivan et al., 1995): this scale investigates pain catastrophizing, which has been highly associated with pain severity and disability after amputation (Hanley et al., 2004; Whyte & Carroll, 2004; Jensen et al., 2002). 0 minimum score -52; Higher scores indicate higher tendency to catastrophizing (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 intervention
Insomnia Severity Index (Bastien et al., 2001): this is a 7-point scale that measure insomnia, a symptom associated with PLP (Durmus et al., 2015). 0 minimum score - 28 maximum score; higher scores indicate more insomnia (worse outcome)
Time frame: baseline, pre-intervention
Technology Acceptance Scale (Morris et al., 1997): this is a 7-point scale that measure level of acceptance of the VR system. 0 minimum score - 133 maximum score; higher scores indicate low level of acceptance (worse score)
Time frame: immediately after the last intervention (session 8 of the intervention);
System Usability Scale (SUS) (Brooke, 1996); Scale measuring the usability of each game; minimum score 10 - maximum score 50. Higher scores indicate less usability (worse outcome).
Time frame: day 1, day 8
Simulator Sickness Questionnaire (Kennedy et al., 1993);
Time frame: day 1, day 8
Brief Slater-Usoh-Steed Presence Questionnaire (Usoh et al., 2000; Slater et al., 1998; 1994). 7 minimum score - 42 maximum score. Higher scores indicate more presence in the VR (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 intervention
The Modified Limb Deficiency and Phantom Limb Questionnaire (Goller et al., 2013): this questionnaire assesses prosthesis type and usage and non-painful phantom limb experiences, including perceived position (e.g., telescoping) and ability to move the phantom. In addition to providing useful descriptive information, prosthesis use and telescoping will be used in the adaptive randomization algorithm to assign subjects to treatments.
Time frame: 1 week after the end of the intervention
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)
Albert Einstein Healthcare Network
Other
Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain: In-Person Treatment
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)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.
Published trials that share one or more normalized conditions with this study.
NCT07565662
Lower Limb Amputation, Nervous System Diseases
Villahermosa, Tabasco, Mexico
View Trial DetailsNCT06071715
Amputation, Surgical, Amputation, Traumatic
La Jolla, California, United States
View Trial DetailsNCT06638918
Nervous System Diseases, Neurobehavioral Manifestations
Winnipeg, Manitoba, Canada
View Trial DetailsNCT05224336
Chronic Pain, Nervous System Diseases
San Diego, California, United States
View Trial Details