CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 23 enrolled
Drug / intervention
Immersive Virtual Realitydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04307446
NCT04307446N/ACompleted

The Feasibility of Immersive Virtual Reality as a Treatment for Chronic Back Pain

Tufts University·interventional·Posted Mar 13, 2020·Updated Aug 15, 2023

In Brief

A clinical study evaluating Immersive Virtual Reality for Chronic Back Pain. Completed, enrolled 23 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

N/ACompletedFinished
202120222023202420252026
First PostedMar 13, 2020
Enrollment StartMay 1, 2021
Primary CompletionJul 6, 2022
Study CompletionMay 31, 2023
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 6.3 years ago

Interventions

Immersive Virtual Realitydevice

Immersive Virtual Reality