Embodiment in Virtual Reality as a Telemedicine Digital Therapeutic for the Treatment of Chronic Shoulder Pain

NCT05375500 | Completed FDA Device

• 1 other identifier: 1
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic shoulder pain is a common musculoskeletal pain condition that can have a profound impact on a sufferer's life and a large socioeconomic healthcare burden to society. The aim of this study was to determine the feasibility of delivering telemedicine enabled functional shoulder rehabilitation for chronic shoulder pain patients using immersive virtual reality. Ten chronic shoulder pain patients were recruited from local pain clinics. Patients engaged in three sessions of virtual embodiment training per week over the course of eight weeks. Rehabilitation sessions were delivered on an Oculus Quest head-mounted display and hand controllers. Rehabilitation exercises (virtual embodiment training) leverage techniques from graded motor imagery, such as visual mirror feedback and augmentation of the virtual avatar's movements. Eight pain assessments were administered prior to the first session, and at weeks four and eight to get an indication of the effect that telemedicine delivered virtual embodiment training has on symptoms of chronic shoulder pain.

Conditions

Chronic Pain; Low Back Pain; Shoulder Pain

Outcome Measures

Primary Outcomes (2)

• Disabilities of the Arm, Shoulder and Hand

  30-item questionnaire that evaluates disability performing upper extremity activities. This questionnaire is a self- report questionnaire that patients can rate difficulty and interference with daily life on a 5 point Likert scale.

  1-2 months

• Upper Extremity Functional Index

  The Upper Extremity Functional Index (UEFI) is a patient reported outcome measure used to assess the functional impairment in individuals with musculoskeletal upper limb dysfunction. The original UEFI consists of 20 questions on a 5- point rating scale assessing level of difficulty in performing activities of daily living using the upper extremities including household and work activities, hobbies, lifting a bag of groceries, washing your scalp, pushing up on your hands, driving etc.

  1-2 months

Secondary Outcomes (4)

• Pain Catastrophizing Scale

  1-2 months

• Fear Avoidance Beliefs

  1-2 months

• Pain Self-efficacy

  1-2 months

• Yellow Flag Risk

  1-2 months

Study Arms (1)

Digital Therapeutic Arm

EXPERIMENTAL

measure the treatment effects of digital therapeutic intervention

Device: telemedicine digital therapeutic

Interventions

telemedicine digital therapeutic DEVICE

digital therapeutics intervention for chronic pain utilizing coaching and virtual reality application

Digital Therapeutic Arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age or older
• Able to wear a VR HMD (head-mounted display)
• Able to attend visits with the frequency outlined in the protocol

You may not qualify if:

• Individuals who have a cognitive impairment
• Susceptibility to motion sickness or simulator-sickness
• History of susceptibility to seizures per subject's reporting
• Pain due to skin infections
• Pain due to blood clots

Sponsors & Collaborators

• Karuna Labs Inc.: lead

Study Sites (1)

Allied Pain & Spine Institute

Los Gatos, California, 95032, United States

Location

MeSH Terms

Conditions

Chronic Pain; Low Back Pain; Shoulder Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Back Pain; Arthralgia; Joint Diseases; Musculoskeletal Diseases

Study Officials

• James Petros, MD

  Chief Medical Officer

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 28, 2022
• First Posted: May 16, 2022
• Study Start: January 1, 2020
• Primary Completion: May 27, 2021
• Study Completion: September 10, 2021
• Last Updated: May 16, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)