Chronic Pain Clinical Trial
Official title:
The Effect of Immersive Virtual Reality on Central Sensitization in People With Chronic Pain: A Proof of Concept Pilot
NCT number | NCT04609787 |
Other study ID # | 2016P000725 |
Secondary ID | |
Status | Withdrawn |
Phase | N/A |
First received | |
Last updated | |
Start date | January 5, 2021 |
Est. completion date | May 1, 2023 |
Verified date | November 2023 |
Source | Tufts University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 25 Years to 65 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Chestnut Hill | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Tufts University | Brigham and Women's Hospital |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | |
Primary | 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 | 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 | |
Secondary | IGroup Presence Questionnaire | User immersion measured with 14 questions related to immersion in IVR experience. Scale of 1-7. | Completed immediately after IVR experience |
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