N/A
N=23
Immersive Virtual Reality and Chronic Back Pain
Chronic Back Pain
Bottom Line
View on ClinicalTrials.gov: NCT04307446 ↗Enrolled (actual)
23
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcome: Primary: Pain Numerical Rating Scale — 0.8; 1.1 units on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Immersive Virtual Reality (Device)
- Age
- Adult, Older Adult · 20+ yrs
- Sex
- All
- Sponsor
- Tufts University
- Primary completion
- Jul 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pain Numerical Rating Scale |
0.8; 1.1 | — |
| PRIMARY Mechanical Pressure Pain Thresholds (MPPTh) |
5.0; 5.0; 4.9; 5.1 | — |
| PRIMARY Mechanical Temporal Summation of Pain (MTSP) |
8.5; 10.0; 8.8; 8.8 | — |
| SECONDARY PANAS |
-1.1; -0.8; -0.7; -0.1 | — |
| SECONDARY PROMIS Fatigue |
0.1; -0.5 | — |
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.
Eligibility Criteria
Inclusion Criteria
- 20 to 75 years old
- Any Back Pain (including neck pain) that has lasted greater than 3 months due to non-cancer related injury or illness.
Exclusion Criteria
- People with back pain primarily due to rheumatic (e.g. rheumatoid arthritis or fibromyalgia)
- people with back pain due to central neurological disorders (e.g. stroke, multiple sclerosis, spinal cord injury)
- has contagious disorder on the face (such as pink eye) that could be transmitted via the VR head set or has open areas on the face that would come in contact with the headset
- had a seizure, loss of awareness, or other symptom linked to an epileptic condition
- insufficient vision to see IVR programs
- insufficient upper extremity coordination to operate IVR controls
- insufficient cognitive ability to answer questionnaires or learn to use the IVR
- unable to understand and respond to English
- Does not own a cell phone or tablet for baseline and follow-up EMA testing.
Data sourced from ClinicalTrials.gov (NCT04307446). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.