NCT04529083: MrMAPP

Mixed Reality Based System to Manage Phantom Pain Phantom Pain for Patients With Lower Limb Amputation

Completed NA Results posted Last updated 3 July 2024

What this trial tests

NA trial testing Mr. MAPP in Phantom Limb Pain in 11 participants. Completed in 31 July 2022.

Timeline

21 May 2018

Primary endpoint
31 July 2022

31 July 2022

Quick facts

Lead sponsor	Dallas VA Medical Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	21 May 2018
Primary completion	31 July 2022
Estimated completion	31 July 2022
Sites	1 location across United States

Drugs / interventions tested

• Mr. MAPP

Conditions studied

• Phantom Limb Pain — all drugs for Phantom Limb Pain →

Sponsor

Dallas VA Medical Center

Who can join

Eligibility, any sex, with Phantom Limb Pain. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Numerical Rating Scale Primary · baseline, 1-month

Pain intensity; 0-10; higher is worse

Baseline

Group	Value	95% CI
Intervention	1.75	1 – 5

1-month

Group	Value	95% CI
Intervention	1.125	1 – 5

Change in McGill Pain Questionnaire Primary · baseline, 1-month

Pain intensity and interference; multiple scales; higher is worse. Range 0-78

Baseline

Group	Value	95% CI
Intervention	38.5	0 – 78

1-month

Group	Value	95% CI
Intervention	31.88	0 – 78

Change in Patient Specific Functional Questionnaire Secondary · baseline, 1-month

Patient specific functional questionnaire; multiple scales; higher is better; Range 0 to 10 for each activity

Baseline

Group	Value	95% CI
Intervention	4.28	0 – 10

1-month

Group	Value	95% CI
Intervention	6.22	0 – 10

Sponsor's own description

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).

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. A novel mixed reality system to manage phantom pain in-home: results of a pilot clinical trial.
   Annapureddy D, Annaswamy TM, Raval G, Chung YY, et al · · 2023 · cited 7× · PMID 37332478 · DOI 10.3389/fpain.2023.1183954
2. Clinical feasibility and preliminary outcomes of a novel mixed reality system to manage phantom pain: a pilot study.
   Annaswamy TM, Bahirat K, Raval G, Chung YY, et al · · 2022 · cited 6× · PMID 36273191 · DOI 10.1186/s40814-022-01187-w