Immersive Virtual Reality and Central Sensitization in People With Chronic Pain
NCT ID: NCT04609787
Last Updated: 2023-11-28
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
NA
INTERVENTIONAL
2021-01-05
2023-05-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
All participants
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.
Immersive 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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Immersive 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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
25 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Brigham and Women's Hospital
OTHER
Tufts University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Nancy Baker
Associate Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Nancy A Baker
Role: PRINCIPAL_INVESTIGATOR
Tufts University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Brigham and Women's Hospital
Chestnut Hill, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2016P000725
Identifier Type: -
Identifier Source: org_study_id