Immersive Healing: The Therapeutic Potential of Virtual Reality
ConditionPhantom Limb Pain (PLP)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorWake Forest University Health Sciences
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
History of major limb amputation
Age > 18 years old
Presence of phantom limb pain or negative phantom sensation(s)
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
virtual reality therapy
Device6 2 times weekly sessions of 30-minute VR therapy in the office with pre- and post-intervention surveys
matched control group
Other interventiontaking the same surveys as the VR intervention group on a weekly basis for 6 weeks
Treatment groups
20 Participants
are divided into 2 treatment groupsGroup A: Virtual Reality (VR) InterventionExperimental treatment 1 intervention
Group B: Matched ControlSham comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline2
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.
Time frame
Week 13
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.
Time frame
Week 24
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.
Time frame
Week 3Secondary outcomes
1
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.
Time frame
Hour 242
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.
Time frame
Week 63
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.
Time frame
Baseline4
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".
Time frame
Week 6Sponsors and contacts
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Source ClinicalTrials.gov