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Immersive Virtual Reality and Central Sensitization in People With Chronic Pain

The Effect of Immersive Virtual Reality on Central Sensitization in People With Chronic Pain: A Proof of Concept Pilot

Status
Withdrawn
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04609787
Enrollment
0
Registered
2020-10-30
Start date
2021-01-05
Completion date
2023-05-01
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Pain

Keywords

Immersive Virtual Reality

Brief summary

Patients with chronic low back pain from Dr. Robert Edwards' study at the Brigham & Women's Pain Institute that examines sensory and pain perceptions in patients with chronic pain who use opioids will complete quantitative sensory testing (QST) and current pain levels will be obtained. Subsequently, 20-minutes of Immersive Virtual Reality (IVR) will be completed and then QST testing will be completed again post-IVR.

Detailed description

We will partner with Dr. Robert Edwards at the Brigham & Women's Pain Institute. Dr. Edward's is an expert in testing central sensitization using quantitative sensory testing (QST).12 QST involves cutaneous (skin) psychophysical (semi-subjective) testing to assess sensory and pain perception pathways.13 QST identifies the intensity of stimuli (touch) is needed to feel something (threshold of detection) and how perception of stimuli changes if it is repeated many times (temporal summation).14 In people with central sensitization, even light intensity of stimulation is perceived as pain and similar intensity stimuli becomes more painful with multiple applications. We hypothesize that people with chronic pain will demonstrate clinically important reductions in the threshold of detection and temporal summation after IVR, which will demonstrate that IVR can affect central sensitization. We will complete two types of QST testing: Mechanical Pressure Pain Thresholds (MPPTh) to test for threshold of detection, and Mechanical Temporal Summation of Pain (MTSP) to test for temporal summation. In MPPTh we will measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants. In MTSP we will apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus. During the study, we will recruit 20 patients with chronic low back pain from Dr. Edwards' study examining sensory and pain perceptions in patients with chronic pain who use opioids. We will complete QST testing and obtain current pain levels. We will complete 20-minutes of IVR, and then complete QST testing again. We will compare pre-IVR MPPTh and MTSP with post IVR levels. We anticipate short term, clinically important decreases in QST levels providing initial confirmation that IVR can positively change central sensitization.

Interventions

DEVICEImmersive Virtual Reality

Participants are placed in three-dimensional, life-sized computer-generated environments via a computer headset shows potential as a treatment for chronic pain and central sensitization.

Sponsors

Brigham and Women's Hospital
CollaboratorOTHER
Tufts University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Pre-IVR MPPTh and MTSP with post IVR levels will be compared.

Eligibility

Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

1. Age 25-65 2. CLBP lasting for more than 6 months as the primary complaint 3. Typical pain ratings ≥ 4/10 on a visual analogue scale 4. Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician. 5. able to speak and understand English

Exclusion criteria

1. Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures 2. current (i.e., active) substance use disorder (SUD). 3. history of myocardial infarction or other serious cardiovascular condition. 4. current peripheral neuropathy. 5. current pregnancy, or intention to become pregnant during the study. 6. current intrathecal pump 7. history of seizures 8. history severe motion sickness

Design outcomes

Primary

MeasureTime frameDescription
Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh)Completed immediately prior to IVR intervention: Approximately 5 minutesTest for threshold of detection: Measure the amount of pressure needed at the shoulder and thumb (body sites that routinely do not have pain in people with low back pain) to elicit a pain report from participants
Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP)Completed immediately prior to IVR intervention: Approximately 5 minutesTest for temporal summation: Apply a train of 10 stimuli (light pinprick) at the rate of 1 per second on the middle finger and have participants rate the painfulness of the first, fifth, and tenth stimulus.
PANASCompleted immediately prior to IVR interventionTwo scales one for Positive and one for Negative Affect - Score for each scale 10 to 50 with a lower score indicating less of that affect
Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2)Completed immediately prior to IVR interventionScale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as none, 10 as worst possible

Secondary

MeasureTime frameDescription
Simulator Sickness QuestionnaireCompleted immediately after IVR experienceScale examining symptoms related to user experience in IVR. 16 symptoms. Scale of none, slight, moderate, severe
IGroup Presence QuestionnaireCompleted immediately after IVR experienceUser immersion measured with 14 questions related to immersion in IVR experience. Scale of 1-7.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026