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Immersive Virtual Reality and Chronic Back Pain

NCT04307446 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 23

Last updated 2023-08-15

Study results available
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Summary

In the proposed project the investigators will evaluate the feasibility of Immersive Virtual Reality (IVR) and assess the initial effects of IVR on symptoms, affect, and tolerance to cutaneous stimuli. In this single-arm trial, the investigators will recruit 20 adults with CBP. Prior to their IVR experience, subjects will complete multiday baseline assessments using ecological momentary assessment (EMA) methodology to establish typical levels of symptoms and affect. Afterward, in a single experimental session, they will participate in two counterbalanced IVR sessions: one 10-minute and one 20-minute. Immediately after each session the investigators will measure current symptoms and affect using valid and reliable self-report questionnaires, and we will measure changes in tolerance to cutaneous stimuli using quantitative sensory testing. We will measure symptoms and affect for 72 hours after the experimental session using EMA to determine if there is a carryover. At the completion of this study, we will continue to work with stakeholders to develop clinically relevant IVR interventions for people with CBP.

Conditions

  • Chronic Back Pain

Interventions

DEVICE

Immersive Virtual Reality

Immersive Virtual Reality

Sponsors & Collaborators

  • Tufts University

    lead OTHER

Principal Investigators

  • Nancy Baker, ScD · Tufts University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
20 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2022-07-06
Completion
2023-05-31
FDA Device
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04307446 on ClinicalTrials.gov