Immersive Healing: The Therapeutic Potential of Virtual Reality

Phantom Limb Pain (PLP) Clinical Trial

Official title:

Immersive Healing: The Therapeutic Potential of Virtual Reality in Phantom Limb Experience

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06077227
• Other study ID #: IRB00100006
• Status: Recruiting
• Phase: N/A
• Start date: December 21, 2023
• Est. completion date: October 2024

Study information

• Verified date: October 2023
• Source: Wake Forest University Health Sciences
• Contact: Joshua Steinke
• Phone: 704-942-4351
• Email: joshua.steinke[@]orthocarolina.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2024
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Phantom Limb
• Phantom Limb Pain (PLP)

Intervention

Device:
• virtual reality therapy
6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys

Other:
• matched control group
taking the same surveys as the VR intervention group on a weekly basis for 6 weeks

Locations

Country	Name	City	State
United States	OrthoCarolina Hand Center	Charlotte	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Baseline
Primary	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.	Week 1
Primary	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.	Week 2
Primary	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.	Week 3
Primary	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.	Week 6
Secondary	Change in Brief Pain Inventory (BPI) 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.	Hour 24
Secondary	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.	Week 6
Secondary	Phantom Limb Experience Survey score	it is qualitative and there is no good or bad, this is just to define the population and better characterize phantom limb experience - assesses presence, onset, location, character, intensity, triggers, and treatment of phantom limb sensations and phantom limb pain. Includes questions on phantom limb posture, movement, size changes, and telescoping.	Baseline
Secondary	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".	Week 6
Secondary	System Usability Scale	Assesses subjective usability and satisfaction with the VR system - A perfect score of 100% signifies flawless usability and an exceptional user experience. The average SUS score is 68, and scores up to 70% are generally considered good; a good sus score indicates a decent level of usability.	Week 6
Secondary	Simulator Sickness Questionnaire	negligible (< 5), minimal (5 - 10), significant (10 - 15), and concerning (15 - 20) symptoms. A simulator resulting in total scores above 20 is considered "bad"	Week 6
Secondary	Change in EuroQol-5 Dimensions-5 Levels (EQ-5D-5L) scores	Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions.EQ-5D-5L index scores range from -0.59 to 1, where 1 is the best possible health state	Week 6