The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05296265
Recruitment Status : Recruiting
First Posted : March 25, 2022
Last Update Posted : April 17, 2024
Sponsor:
Collaborators:
University of Pennsylvania
University of Washington
Information provided by (Responsible Party):
Laurel Buxbaum, Albert Einstein Healthcare Network

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.

Condition or disease Intervention/treatment Phase
Phantom Limb Pain Behavioral: VR treatment for phantom limb pain Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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.
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain: In-Person Treatment
Actual Study Start Date : May 10, 2022
Estimated Primary Completion Date : December 1, 2024
Estimated Study Completion Date : April 1, 2025

Arm Intervention/treatment
Experimental: Active VR treatment
Subjects assigned to the Active VR treatment will begin by selecting an avatar, with features such as gender and skin color that can be chosen according to preference. During treatment, they will participate 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 will have substantial flexibility to select games according to their interests but will be required to spend at least 30 minutes in each session in games that require forceful, large amplitude, movements of the amputated lower limb (e.g., Quest for Fire, Kick). Time spent and level of engagement as measured by movements of the avatar or, in the case of chess, checkers, solitaire, Sudoku, and internet surfing, the number of clicks produced with each leg will be recorded for each activity using custom software
Behavioral: VR treatment for phantom limb pain
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

Experimental: Distractor VR treatment
Subjects assigned to the Distractor VR treatment will participate in REAL i-Series immersive VR experience (REAL system), which has been demonstrated to reduce pain in several studies but lacks the hypothesized "active ingredients" of our Active VR treatment (visual and auditory feedback of movement of an extrapolated amputated limb). Subjects will navigate through pleasant and relaxing VR environments; they will not see any rendering of their body and make no movements with their legs
Behavioral: VR treatment for phantom limb pain
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




Primary Outcome Measures :
  1. Changes in pain intensity [ 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)

  2. Changes in pain quality [ 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


Secondary Outcome Measures :
  1. Changes in average pain after the treatment [ 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)


Other Outcome Measures:
  1. Changes in daily activities after the treatment [ 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).

  2. Changes in quality of life after the treatment [ 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).

  3. Changes in pain interference after the treatment [ 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).

  4. Changes in depression and anxiety as effect of the treatment [ 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)

  5. Changes in the pain catastrophizing after the treatment [ 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)

  6. Changes in insomnia after the treatment [ 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)

  7. Perception of VR system [ 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)

  8. Usability of each game [ 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).

  9. Cybersickness [ Time Frame: day 1, day 8 ]
    Simulator Sickness Questionnaire (Kennedy et al., 1993);

  10. Presence in VR [ 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

  11. Changes in PL and PLP after the treatment [ 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.

  12. Treatment satisfaction [ 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)



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05296265


Contacts
Layout table for location contacts
Contact: Laurel Buxbaum (215) 456-9901 Lbuxbaum@einstein.edu

Locations
Layout table for location information
United States, Pennsylvania
Moss Rehabilitation Research Institute Recruiting
Elkins Park, Pennsylvania, United States, 19027
Contact: Laurel Buxbaum, PsyD    215-456-9901    lbuxbaum@einstein.edu   
University of Pennsylvania Recruiting
Philadelphia, Pennsylvania, United States, 19104
Contact: Branch Coslett, MD    215-613-3428    hbc@pennmedicine.upenn.edu   
United States, Washington
University of Washington-Harborview Medical Center Recruiting
Seattle, Washington, United States, 98104
Contact: Erick S Rombokas, PhD       rombokas@uw.edu   
Sponsors and Collaborators
Albert Einstein Healthcare Network
University of Pennsylvania
University of Washington
Investigators
Layout table for investigator information
Principal Investigator: Laurel Buxbaum, PsyD Albert Einstein Healthcare Netork
Publications of Results:

Layout table for additonal information
Responsible Party: Laurel Buxbaum, Associate Director, Moss Rehabilitation Research Institute, Albert Einstein Healthcare Network
ClinicalTrials.gov Identifier: NCT05296265    
Other Study ID Numbers: 2022-775.
First Posted: March 25, 2022    Key Record Dates
Last Update Posted: April 17, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: After de-identification, individual participant data to be shared will include descriptors of clinical status (e.g., time since amputation, level of amputation), background test battery results, and outcome measures results.
Supporting Materials: Study Protocol
Time Frame: Immediately following publication. No end date.
Access Criteria: Researchers who provide a sound rationale.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Phantom Limb
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain