Immersive Healing: The Therapeutic Potential of Virtual Reality
Primary Purpose
Phantom Limb Pain (PLP)
Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
virtual reality therapy
matched control group
Sponsored by
About this trial
This is an interventional treatment trial for Phantom Limb Pain (PLP) focused on measuring amputee, pain management, virtual reality (VR) therapy
Eligibility Criteria
Inclusion Criteria: History of major limb amputation Age > 18 years old Presence of phantom limb pain or negative phantom sensation(s) Exclusion Criteria: Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion Those without phantom limb pain or negative phantom limb sensations Non-English speaking
Sites / Locations
- OrthoCarolina Hand Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Sham Comparator
Arm Label
Virtual Reality (VR) Intervention
Matched Control
Arm Description
Individuals undergoing virtual reality therapy intervention
The matched controls will receive standard care without the VR intervention
Outcomes
Primary Outcome Measures
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Secondary Outcome Measures
Change in Brief Pain Inventory (BPI) interference scale scores
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain - Scores range from 0 to 10 with higher scores indicating greater pain interference.
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale with 0 equal to no pain and 10 equal to the worst pain ever during the past week. The total score is calculated by summing 22 individual scores.
Phantom Limb Experience Survey score
This is only being administered once at the beginning of study - it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience.
Change in Virtual Reality (VR) Therapy Survey scores
There are several questions within this survey to assess attitude towards VR, which activities are favored and then the effect VR had on them. There is a mix of qualitative questions and quantitative. Quantitative questions are on Likert Scale 1-5. An interval change of +1 on Likert scale would be "good" for question on posture, control over limb. For how long the therapy effect lasts after session is over, it will vary from hours to days to weeks (which is why all descriptors are in there). Even if it lasted 1 hour this would be considered "good".
Change in Patient Health Questionnaire-9 (PHQ-9) scores
Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Full Information
NCT ID
NCT06077227
First Posted
October 4, 2023
Last Updated
October 4, 2023
Sponsor
Wake Forest University Health Sciences
1. Study Identification
Unique Protocol Identification Number
NCT06077227
Brief Title
Immersive Healing: The Therapeutic Potential of Virtual Reality
Official Title
Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
November 2023 (Anticipated)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Wake Forest University Health Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Phantom limb pain (PLP) is a significant and pervasive issue among upper limb amputees, severely impacting their quality of life. The literature delineating prevalence of upper versus lower limb amputations is limited, but the prevalence of total amputations in the United States is estimated to reach 3 million individuals by 2050, with approximately 185,000 new cases annually. PLP affects 60-68% of these patients, leading to heightened levels of anxiety, depression, and reduced overall well-being.
Detailed Description
Although studies exploring the efficacy of VR therapy for PLP have reported positive outcomes, several limitations, such as small sample sizes, lack of randomization, and inconsistent treatment protocols, have impeded widespread adoption of these innovative approaches. Additionally, the literature does not sufficiently delineate which aspects of the phantom limb experience may be addressed with VR therapy. To overcome these limitations and optimize treatment efficacy, it is crucial to gain a comprehensive understanding of the phantom limb experience, including both somatosensory and kinesthesia-related symptoms. Additionally, this study will address these limitations by employing a larger sample size, rigorous methodology, and a standardized treatment protocol.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phantom Limb Pain (PLP)
Keywords
amputee, pain management, virtual reality (VR) therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Pre- and post-intervention surveys will be used to assess the effects of virtual reality (VR) therapy on the phantom limb experience in the intervention group. Matched controls from the registry will be surveyed on their phantom limb symptoms at matching time intervals to the intervention group for comparison.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Virtual Reality (VR) Intervention
Arm Type
Experimental
Arm Description
Individuals undergoing virtual reality therapy intervention
Arm Title
Matched Control
Arm Type
Sham Comparator
Arm Description
The matched controls will receive standard care without the VR intervention
Intervention Type
Behavioral
Intervention Name(s)
virtual reality therapy
Other Intervention Name(s)
VR Intervention
Intervention Description
4 weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
Intervention Type
Other
Intervention Name(s)
matched control group
Other Intervention Name(s)
control group
Intervention Description
taking the same surveys as the VR intervention group on a weekly basis for 4 weeks
Primary Outcome Measure Information:
Title
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Description
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Time Frame
Baseline
Title
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Description
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Time Frame
Week 1
Title
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Description
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Time Frame
Week 2
Title
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Description
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Time Frame
Week 3
Title
Phantom limb pain levels using Short-form McGill Pain Questionnaire (SF-MPQ)
Description
Short-form McGill Pain Questionnaire - The maximum score an individual can reach on the MPQ is 78. According to the questionnaire, a person with a score of 0 effectively does not experience pain. A person with a high score, nearer to the highest score of 78, more than likely deals with chronic pain daily.
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change in Brief Pain Inventory (BPI) interference scale scores
Description
Worst Pain Score: 1 - 4 = Mild Pain. Worst Pain Score: 5 - 6 = Moderate Pain. Worst Pain Score: 7 - 10 = Severe Pain - Scores range from 0 to 10 with higher scores indicating greater pain interference.
Time Frame
Week 4
Title
Change in Short-Form McGill Pain Questionnaire (SF-MPQ) scores
Description
A short form of the McGill Pain Questionnaire (SF-MPQ) has been developed. The main component of the SF-MPQ consists of 15 descriptors (11 sensory; 4 affective) which are rated on an intensity scale as 0 = none, 1 = mild, 2 = moderate or 3 = severe.
Consists of 22 different descriptors of pain and each item is rated based on a 0-10 scale with 0 equal to no pain and 10 equal to the worst pain ever during the past week. The total score is calculated by summing 22 individual scores.
Time Frame
Week 4
Title
Phantom Limb Experience Survey score
Description
This is only being administered once at the beginning of study - it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience.
Time Frame
Baseline
Title
Change in Virtual Reality (VR) Therapy Survey scores
Description
There are several questions within this survey to assess attitude towards VR, which activities are favored and then the effect VR had on them. There is a mix of qualitative questions and quantitative. Quantitative questions are on Likert Scale 1-5. An interval change of +1 on Likert scale would be "good" for question on posture, control over limb. For how long the therapy effect lasts after session is over, it will vary from hours to days to weeks (which is why all descriptors are in there). Even if it lasted 1 hour this would be considered "good".
Time Frame
Week 4
Title
Change in Patient Health Questionnaire-9 (PHQ-9) scores
Description
Scores less than 5 almost always signified the absence of a depressive disorder; scores of 5 to 9 predominantly represented patients with either no depression or subthreshold (i.e., other) depression; scores of 10 to 14 represented a spectrum of patients; and scores of 15 or greater usually indicated major depression.
Time Frame
Week 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
History of major limb amputation
Age > 18 years old
Presence of phantom limb pain or negative phantom sensation(s)
Exclusion Criteria:
Active mental illness, neurological disease, or cognitive impairment that would interfere with survey completion
Those without phantom limb pain or negative phantom limb sensations
Non-English speaking
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joshua Steinke
Phone
704-942-4351
Email
joshua.steinke@orthocarolina.com
First Name & Middle Initial & Last Name or Official Title & Degree
Ben Connell
Email
ben.connell@orthocarolina.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Glenn Gaston, MD
Organizational Affiliation
Atrium Health Musculoskeletal Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
OrthoCarolina Hand Center
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28207
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joshua Steinke
Phone
704-942-4351
Email
joshua.steinke@orthocarolina.com
First Name & Middle Initial & Last Name & Degree
ben Connell
Email
ben.connell@orthocarolina.com
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Individual Participant Data that underlie the results reported in this article, after deidentification
IPD Sharing Time Frame
Beginning 3 months and ending 5 years following article publication
IPD Sharing Access Criteria
Researchers who provide a methodologically sound proposal
Learn more about this trial
Immersive Healing: The Therapeutic Potential of Virtual Reality
We'll reach out to this number within 24 hrs