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

NCT04529083 | Completed Results

• 1 other identifier: 18-016
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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).

Conditions

Phantom Limb Pain

Keywords

mixed reality; phantom limb pain

Outcome Measures

Primary Outcomes (2)

• Change in Numerical Rating Scale

  Pain intensity; 0-10; higher is worse

  baseline, 1-month

• Change in McGill Pain Questionnaire

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

  baseline, 1-month

Secondary Outcomes (1)

• Change in Patient Specific Functional Questionnaire

  baseline, 1-month

Study Arms (1)

Intervention

EXPERIMENTAL

Mixed Reality System for virtual mirror therapy

Device: Mr. MAPP

Interventions

Mr. MAPP DEVICE

Mixed reality device to provide virtual mirror therapy to patients with phantom pain

Intervention

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Men and women, over the age of 18 with lower limb amputations (greater than 3 months post surgery) with phantom limb pain

You may not qualify if:

• 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.

Sponsors & Collaborators

• Dallas VA Medical Center: lead
• The University of Texas at Dallas: collaborator

Study Sites (1)

VA North Texas Health Care System

Dallas, Texas, 75216, United States

Location

Related Publications (2)

• Annapureddy D, Annaswamy TM, Raval G, Chung YY, Prabhakaran B. A novel mixed reality system to manage phantom pain in-home: results of a pilot clinical trial. Front Pain Res (Lausanne). 2023 Jun 2;4:1183954. doi: 10.3389/fpain.2023.1183954. eCollection 2023.

  PMID: 37332478 DERIVED

• Annaswamy TM, Bahirat K, Raval G, Chung YY, Pham T, Prabhakaran B. Clinical feasibility and preliminary outcomes of a novel mixed reality system to manage phantom pain: a pilot study. Pilot Feasibility Stud. 2022 Oct 22;8(1):232. doi: 10.1186/s40814-022-01187-w.

  PMID: 36273191 DERIVED

MeSH Terms

Conditions

Phantom Limb

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain

Results Point of Contact

• Title: Dr. James Le Page
• Organization: VA North Texas Health Care System

james.lepage@va.gov

214-857-1437

Study Officials

• Gargi Raval, MD

  North Texas Veterans Healthcare System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Staff Physician and Professor

Model Details: Pilot study to evaluate feasibility

Study Record Dates

• First Submitted: August 24, 2020
• First Posted: August 27, 2020
• Study Start: May 21, 2018
• Primary Completion: July 31, 2022
• Study Completion: July 31, 2022
• Last Updated: July 3, 2024
• Results First Posted: July 3, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)