N/A
N=11
Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation
Phantom Limb Pain
Bottom Line
View on ClinicalTrials.gov: NCT04529083 ↗Enrolled (actual)
11
Serious AEs
0.0%
Results posted
Jul 2024
Primary outcome: Primary: Change in Numerical Rating Scale — 1.75; 1.125 score on a scale — p=0.011
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Mr. MAPP (Device)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- Dallas VA Medical Center
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Numerical Rating Scale |
1.75; 1.125 | 0.011 sig |
| PRIMARY Change in McGill Pain Questionnaire |
38.5; 31.88 | — |
| SECONDARY Change in Patient Specific Functional Questionnaire |
4.28; 6.22 | 0.006 sig |
Summary
The primary goals of this pilot research project are a) to design and develop the a mixed reality based system for managing phantom pain and b) to evaluate the feasibility and preliminary functional outcomes of this system in a sample of patients with lower limb amputation. Findings from this pilot study will serve as preliminary data to inform regarding a fully powered clinical trial to determine the effectiveness and practical implementation of these findings in real-world settings.
Aim1: Design and develop a feasible mixed reality based system to manage phantom pain in patients with lower limb amputation qualifying for on-going mirror therapy.
Hypothesis 1: The investigators hypothesize that the mixed reality based system to manage phantom pain will be feasible and well-received by a sample of patients with lower limb amputation needing mirror therapy.
Aim2: Evaluate functional outcomes in a sample of lower limb amputees (n=10), using this mixed reality based system to manage phantom pain.
Hypothesis 2: Using this system, the investigators hypothesize that patients who participate in the mixed reality based system will show improvements in functional mobility based on performance evaluations and patient reported outcome measures (PROs). The investigators also hypothesize that this mixed reality based system will help to alleviate the phantom pain based on McGill Pain questionnaire and visual analog scale (VAS).
Eligibility Criteria
Inclusion Criteria
- Men and women, over the age of 18 with lower limb amputations (greater than 3 months post surgery) with phantom limb pain
Exclusion Criteria
- Patients with lower limb amputations with open wounds or active infection in residual or contralateral limbs.
- Patients with history of seizures.
- Patients with visual (self-reported) or cognitive impairment (assessed by the mini-mental state examination) that interferes with ability to interact with, participate in, and adhere to a computerized rehabilitation system.
- Any patient with a cardiac event in the last 6 months.
- Any patient with an active medical issue to minimize risk of exacerbating their condition.
- Lives more than 60 miles away from the Dallas VA Medical Center
- Any patient with the motion sickness induced by head mounted displays (HMDs) or immersive environment.
- Any patient experiencing the motion sickness induced by HMDs during the therapy session can also opt out of the study.
Data sourced from ClinicalTrials.gov (NCT04529083). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.