Immersive Virtual Reality and Central Sensitization in People With Chronic Pain

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Chronic Pain

Intervention / Treatment
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* Device: Immersive Virtual Reality


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 25-65 CLBP lasting for more than 6 months as the primary complaint Typical pain ratings ≥ 4/10 on a visual analogue scale Currently prescribed oral opioid therapy and under consideration for dose reduction by the prescribing clinician. able to speak and understand English Exclusion Criteria: Evidence of delirium, dementia, psychosis, or other cognitive impairment preventing completion of study procedures current (i.e., active) substance use disorder (SUD). history of myocardial infarction or other serious cardiovascular condition. current peripheral neuropathy. current pregnancy, or intention to become pregnant during the study. current intrathecal pump history of seizures history severe motion sickness

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: Pre-IVR MPPTh and MTSP with post IVR levels will be compared.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: All participants<br>Quantitative sensory testing will be completed and current pain levels obtained. 20-minutes of immersive virtual reality will be completed, and then complete quantitative sensory testing again. We will compare pre-IVR quantitative sensory testing with post IVR levels. | Device: Immersive Virtual Reality<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh) | Test 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 | Completed immediately prior to IVR intervention: Approximately 5 minutes | 
| Quantitative sensory testing (QST): Mechanical Pressure Pain Thresholds (MPPTh) | Test 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 | Completed immediately after IVR intervention: Approximately 5 minutes | 
| Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP) | Test 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. | Completed immediately prior to IVR intervention: Approximately 5 minutes | 
| Quantitative sensory testing (QST): Mechanical Temporal Summation of Pain (MTSP) | Test 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. | Completed immediately after IVR intervention: Approximately 5 minutes | 
| PANAS | Two 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 | Completed immediately prior to IVR intervention | 
| PANAS | Two 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 | Completed immediately after IVR intervention | 
| Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as none, 10 as worst possible | Completed immediately prior to IVR intervention | 
| Short-Form McGill Pain Questionnaire-2 (SF-MPQ-2) | Scale examining quality of pain with 22 possible pain related symptoms - Score for each scale 0 - 10; 0 as none, 10 as worst possible | Completed immediately after IVR intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Simulator Sickness Questionnaire | Scale examining symptoms related to user experience in IVR. 16 symptoms. Scale of none, slight, moderate, severe | Completed immediately after IVR experience | 
| IGroup Presence Questionnaire | User immersion measured with 14 questions related to immersion in IVR experience. Scale of 1-7. | Completed immediately after IVR experience | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Immersive Virtual Reality