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Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

Primary Purpose

Phantom Limb Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
VR treatment for phantom limb pain
Sponsored by
Albert Einstein Healthcare Network
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phantom Limb Pain

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 24 or greater
  5. Pain averaged over the preceding 1 month in the phantom limb rated as greater than 40 on the visual analog scale of the McGill Pain Questionnaire (Melzack, 1987)

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

Sites / Locations

  • Moss Rehabilitation Research InstituteRecruiting
  • University of PennsylvaniaRecruiting
  • University of Washington-Harborview Medical CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Active VR treatment

Distractor VR treatment

Arm Description

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

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

Outcomes

Primary Outcome Measures

Changes in pain intensity
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)
Changes in pain quality
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

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)

Full Information

First Posted
February 9, 2022
Last Updated
July 14, 2023
Sponsor
Albert Einstein Healthcare Network
Collaborators
University of Pennsylvania, University of Washington
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1. Study Identification

Unique Protocol Identification Number
NCT05296265
Brief Title
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

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 10, 2022 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 1, 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Albert Einstein Healthcare Network
Collaborators
University of Pennsylvania, University of Washington

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active VR treatment
Arm Type
Experimental
Arm Description
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
Arm Title
Distractor VR treatment
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
VR treatment for phantom limb pain
Intervention Description
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 Measure Information:
Title
Changes in pain intensity
Description
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
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
Title
Changes in pain quality
Description
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
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 Outcome Measure Information:
Title
Changes in average pain after the treatment
Description
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 weeks
Other Pre-specified Outcome Measures:
Title
Changes in daily activities after the treatment
Description
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
Title
Changes in quality of life after the treatment
Description
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
Title
Changes in pain interference after the treatment
Description
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
Title
Changes in depression and anxiety as effect of the treatment
Description
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
Title
Changes in the pain catastrophizing after the treatment
Description
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
Title
Changes in insomnia after the treatment
Description
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; immediately after the end of the intervention; 1 week after the end of the intervention; 8 weeks after the end of the intervention
Title
Perception of VR system
Description
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
baseline, pre-intervention
Title
Usability of each game
Description
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
immediately after the last intervention (session 8 of the intervention);
Title
Cybersickness
Description
Simulator Sickness Questionnaire (Kennedy et al., 1993);
Time Frame
day 1, day 8
Title
Presence in VR
Description
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
day 1, day 8
Title
Changes in PL and PLP after the treatment
Description
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
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
Title
Treatment satisfaction
Description
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)
Time Frame
1 week after the end of the intervention

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 18 - 100 years 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 greater Pain averaged over the preceding 1 month in the phantom limb rated as greater than 4 on a scale of 0-10. Exclusion Criteria: 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 Current significant depression or anxiety as judged by the Hospital Anxiety and Depression Scale (HADS) (Zigmond & Snaith, 1983). Current abuse of alcohol or drugs, prescription or otherwise Nursing a child, pregnant, or intent to become pregnant during the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Laurel Buxbaum
Phone
(215) 456-9901
Email
Lbuxbaum@einstein.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Laurel Buxbaum, PsyD
Organizational Affiliation
Albert Einstein Healthcare Netork
Official's Role
Principal Investigator
Facility Information:
Facility Name
Moss Rehabilitation Research Institute
City
Elkins Park
State/Province
Pennsylvania
ZIP/Postal Code
19027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurel Buxbaum, PsyD
Phone
215-456-9901
Email
lbuxbaum@einstein.edu
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Branch Coslett, MD
Phone
215-613-3428
Email
hbc@pennmedicine.upenn.edu
Facility Name
University of Washington-Harborview Medical Center
City
Seattle
State/Province
Washington
ZIP/Postal Code
98104
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Erick S Rombokas, PhD
Email
rombokas@uw.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing 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.
IPD Sharing Time Frame
Immediately following publication. No end date.
IPD Sharing Access Criteria
Researchers who provide a sound rationale.
Citations:
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3670870
Citation
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6869117
Citation
Holbrook M, Skilbeck CE. An activities index for use with stroke patients. Age Ageing. 1983 May;12(2):166-70. doi: 10.1093/ageing/12.2.166.
Results Reference
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PubMed Identifier
8628042
Citation
Ware J Jr, Kosinski M, Keller SD. A 12-Item Short-Form Health Survey: construction of scales and preliminary tests of reliability and validity. Med Care. 1996 Mar;34(3):220-33. doi: 10.1097/00005650-199603000-00003.
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PubMed Identifier
8080219
Citation
Cleeland CS, Ryan KM. Pain assessment: global use of the Brief Pain Inventory. Ann Acad Med Singap. 1994 Mar;23(2):129-38.
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PubMed Identifier
22981809
Citation
Goller AI, Richards K, Novak S, Ward J. Mirror-touch synaesthesia in the phantom limbs of amputees. Cortex. 2013 Jan;49(1):243-51. doi: 10.1016/j.cortex.2011.05.002. Epub 2011 Jun 22.
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Citation
Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
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PubMed Identifier
11438246
Citation
Bastien CH, Vallieres A, Morin CM. Validation of the Insomnia Severity Index as an outcome measure for insomnia research. Sleep Med. 2001 Jul;2(4):297-307. doi: 10.1016/s1389-9457(00)00065-4.
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Citation
Slater M, Steed A, McCarthy J, Maringelli F. The influence of body movement on subjective presence in virtual environments. Hum Factors. 1998 Sep;40(3):469-77. doi: 10.1518/001872098779591368.
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Suresh K. An overview of randomization techniques: An unbiased assessment of outcome in clinical research. J Hum Reprod Sci. 2011 Jan;4(1):8-11. doi: 10.4103/0974-1208.82352.
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Citation
Ambron E, Buxbaum LJ, Miller A, Stoll H, Kuchenbecker KJ, Coslett HB. Virtual Reality Treatment Displaying the Missing Leg Improves Phantom Limb Pain: A Small Clinical Trial. Neurorehabil Neural Repair. 2021 Dec;35(12):1100-1111. doi: 10.1177/15459683211054164. Epub 2021 Oct 27.
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Efficacy and Mechanisms of Virtual Reality Treatment of Phantom Leg Pain

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