Immersive Virtual Reality for Chronic Pain
Recruiting in Palo Alto (17 mi)
Overseen byLuana Colloca, MD/PhD/MS
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 1 & 2
Recruiting
Sponsor: University of Maryland, Baltimore
Must not be taking: Antidepressants, ADHD meds, Narcotics, others
Disqualifiers: Cardiovascular, Neurological, Psychiatric, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This trial investigates using virtual reality to help people with chronic pain from Temporomandibular Disorders (TMD). The VR experience aims to distract the brain from pain and may also trigger the release of natural pain-relieving chemicals. Researchers will compare the effects of real VR to see how effective it is. Virtual reality (VR) has been increasingly studied and used as a tool for pain management in various conditions, including chronic pain, procedural pain, and specific syndromes like complex regional pain syndrome and phantom limb pain.
Will I have to stop taking my current medications?
Yes, you will need to stop taking certain medications, such as antidepressants, ADHD medication, non-over-the-counter painkillers, methadone, benzodiazepines, barbiturates, and narcotics, if you have used them in the past 3 months.
What data supports the effectiveness of the treatment Immersive Virtual Reality for Chronic Pain?
Research shows that virtual reality (VR) can help reduce chronic pain, with studies indicating improvements in pain-related outcomes for conditions like chronic back pain and phantom limb pain. VR therapy has been associated with significant pain reduction and improved overall functioning, suggesting it can be an effective non-drug treatment for managing chronic pain.
12345Is immersive virtual reality safe for treating chronic pain?
Research on virtual reality for pain treatment shows it is generally safe, with few studies reporting side effects. However, more research is needed to fully understand any potential risks.
12678How does the immersive virtual reality treatment for chronic pain differ from other treatments?
Immersive virtual reality (VR) is unique because it offers a non-drug approach to managing chronic pain by using technology to create an engaging and interactive environment that can distract patients from their pain. Unlike traditional treatments, VR can provide immediate pain relief during and shortly after sessions, and it has shown promise in reducing pain intensity across various chronic pain conditions.
12459Eligibility Criteria
This trial is for English-speaking adults aged 18-88 with Temporomandibular Disorder (TMD) for at least 3 months. Excluded are those with certain psychiatric conditions, recent substance abuse, pregnancy, color-blindness, severe facial trauma or motion sickness, and those on specific medications like antidepressants.Inclusion Criteria
I have had jaw pain or dysfunction for at least 3 months.
I can speak and write in English.
I am between 18 and 88 years old.
Exclusion Criteria
I have not had any facial injuries in the last 6 weeks.
You have had very bad motion sickness in the past.
You have tested positive for illegal drugs like opiates, cocaine, methamphetamines, amphetamines, and THC.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants undergo VR sessions and receive either naloxone or saline to assess VR-induced hypoalgesia
1 session lasting 2 to 3 hours
1 visit (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study explores how immersive virtual reality can manage chronic pain compared to placebo effects. It involves active VR treatment, sham VR (placebo), no intervention control groups, and the administration of Naloxone or Saline to understand pain mechanisms.
3Treatment groups
Experimental Treatment
Active Control
Placebo Group
Group I: Natural HistoryExperimental Treatment4 Interventions
Natural history group, where participants will not be given any drugs. Participants will be stratified for sex and then randomized to the Natural History group.
Group II: NaloxoneActive Control4 Interventions
NARCAN® Naloxone Nasal Spray will be used to determine how the opioid tone shapes VR-induced hypoalgesia. Participants will be stratified for sex and then randomized to naloxone (The dose of naloxone will be 4 mg, so 0.1 mL of 40 mg/ml naloxone solution given intranasally) or saline (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
Group III: SalinePlacebo Group4 Interventions
Saline group, where participants will be given saline solution (4mg) via an identical spray device. Participants will be stratified for sex and then randomized to saline arm (The dose of saline will be (0.1 mL 0.9% sodium chloride intranasally), respectively. Investigators, staff, and participants will be blinded to the treatment options.
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Luana CollocaBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
Use and efficacy of virtual, augmented, or mixed reality technology for chronic pain: a systematic review. [2023]Aim: Characterize use and efficacy/effectiveness of virtual, augmented, or mixed reality (VR/AR/MR) technology as non-pharmacological therapy for chronic pain. Methods: Systematic search of 12 databases to identify empirical studies, of individuals who experience chronic pain or illness involving chronic pain, published between 1990 and 2021. JBI Critical Appraisal Checklists assessed study bias and a narrative synthesis was provided. Results: 46 studies, investigating a total of 1456 participants and including 19 randomized controlled trials (RCT), were reviewed. VR/AR/MR was associated with improved pain-related outcomes in 78% of the RCTs. Conclusion: While most studies showed effects immediately or up to one month post treatment, RCTs are needed to further evaluate VR/AR/MR, establish long-term benefits, and assess accessibility, especially among individuals who experience pain management disparities.
The Impact of Virtual Reality on Chronic Pain. [2022]The treatment of chronic pain could benefit from additional non-opioid interventions. Virtual reality (VR) has been shown to be effective in decreasing pain for procedural or acute pain but to date there have been few studies on its use in chronic pain. The present study was an investigation of the impact of a virtual reality application for chronic pain. Thirty (30) participants with various chronic pain conditions were offered a five-minute session using a virtual reality application called Cool! Participants were asked about their pain using a 0-10 visual analog scale rating before the VR session, during the session and immediately after the session. They were also asked about immersion into the VR world and about possible side effects. Pain was reduced from pre-session to post-session by 33%. Pain was reduced from pre-session during the VR session by 60%. These changes were both statistically significant at the p
The Effects of Virtual Reality Neuroscience-based Therapy on Clinical and Neuroimaging Outcomes in Patients with Chronic Back Pain: A Randomized Clinical Trial. [2023]Chronic pain remains poorly managed. The integration of innovative immersive technologies (i.e., virtual reality (VR)) with recent neuroscience-based principles that position the brain as the key organ of chronic pain may provide a more effective pain treatment than traditional behavioral therapies. By targeting cognitive and affective processes that maintain pain and potentially directly changing neurobiological circuits associated with pain chronification and amplification, VR-based pain treatment has the potential for significant and long-lasting pain relief. We tested the effectiveness of a novel VR neuroscience-based therapy (VRNT) to improve pain-related outcomes in n = 31 participants with chronic back pain, evaluated against usual care (n = 30) in a 2-arm randomized clinical trial ( NCT04468074) . We also conducted pre- and post-treatment MRI to test whether VRNT affects brain networks previously linked to chronic pain and treatment effects. Compared to the control condition, VRNT led to significantly reduced pain intensity (g = 0.63) and pain interference (g = 0.84) at post-treatment vs. pre-treatment, with effects persisting at 2-week follow-up. The improvements were partially mediated by reduced kinesiophobia and pain catastrophizing. Several secondary clinical outcomes were also improved, including disability, quality of life, sleep, and fatigue. In addition, VRNT was associated with modest increases in functional connectivity of the somatomotor and default mode networks and decreased white matter fractional anisotropy in the corpus callosum adjacent to anterior cingula, relative to the control condition. This, VRNT showed preliminary efficacy in significantly reducing pain and improving overall functioning, possibly via changes in somatosensory and prefrontal brain networks.
The effect of interactive virtual reality on pain perception: a systematic review of clinical studies. [2021]Purpose: The aim of this systematic review was to evaluate the effect of immersive and non-immersive interactive virtual reality on pain perception in patients with a clinical pain condition.Methods: The following databases were searched from inception: Medline (Ovid), PsychInfo, CINAHL, Cochrane library and Web of Science. Two reviewers screened reports and extracted the data. A third reviewer acted as an arbiter. Studies were eligible if they were randomized controlled trials, quasi-randomized trials, and uncontrolled trials. Crossover and parallel-group designs were included. Risk of bias was assessed for all included studies.Results: Thirteen clinical studies were included. The majority of studies investigated a sample of participants with chronic pain. Six were controlled trials and seven uncontrolled studies. Findings from controlled research suggest that interactive virtual reality may reduce pain associated with ankylosing spondylitis and post-mastectomy, but results are inconsistent for patients with neck pain. Findings from uncontrolled studies suggest that interactive virtual reality may reduce neuropathic limb pain, and phantom limb pain, but had no effect on nonspecific chronic back pain.Conclusions: There is a need for more rigorous randomized control trials in order to conclude on the effectiveness of the use of virtual reality for the management of pain.Implications for rehabilitationInteractive virtual reality has been increasingly used in the rehabilitation of painful conditions.Interactive virtual reality using exergames may promote distraction from painful exercises and reduce pain post-mastectomy and in patients with ankylosing spondylitis.Interactive virtual representation of limbs may reduce neuropathic and phantom limb pain.
Effectiveness of Virtual Reality-Based Interventions for Managing Chronic Pain on Pain Reduction, Anxiety, Depression and Mood: A Systematic Review. [2022](1) Background: Patients diagnosed with chronic pain suffer from long-term pain, which negatively affects their daily lives and mental health. Virtual reality (VR) technologies are considered a therapeutic tool to manage pain perception and mental health conditions. This systematic review aimed to appraise the efficacy of VR in improving pain intensity, anxiety, depression and mood among patients with chronic pain; (2) Methods: Five electronic databases were systematically searched using the terms representing VR and chronic pain. Quality assessment was conducted using Cochrane Collaboration's tool and Newcastle-Ottawa scale; (3) Results: Seventeen peer-reviewed articles were included in this review. It was found that VR was able to reduce pain intensity in patients with phantom limb pain, chronic headache, chronic neck pain and chronic low-back pain. The effects of VR on the improvement of anxiety, depression and mood were not determined due to the inadequate amount of clinical evidence; (4) Conclusions: VR, especially immersive VR, improves pain outcomes and its effects may vary depending on the approach and study design. More research is still needed to investigate the clinical use of VR in patients with chronic pain.
[Use of Virtual Reality as a Component of Acute and Chronic Pain Treatment]. [2020]Future or reality? Treating acute and chronic pain is a part of the daily routine of clinical anesthesiologists. Commonly used analgesics have unwanted side effects or may even be insufficient as in chronic pain treatment. Virtual Reality (VR) could be a promising new approach which offers noninvasive therapy options for the treatment of pain. In case of the opioid misuse the adjunctive treatment is mandatory. Various phenomena occur in VR, such as immersion, presence, embodiment and Proteus effect, which can cause a change in body awareness and behavior. Experimental and clinical studies already yielded some promising results for analgesic effects for acute and chronic pain conditions using VR simulation. Potential analgesic mechanisms include distraction, cognitive behavioral change, and distance from reality, leading to neurophysiological changes at the cortical level. The quality of the virtual environment, personalized avatars, as well as the possibility of interaction and multisensory input can increase immersion, which leads to a state of presence, and thus effective VR. VR can be used as an immersive extension or alternative to mirror therapy, especially for pain disorders such as complex regional pain syndrome (CRPS) or phantom limb pain. VR can be supplemented by gamification, which increases intrinsic motivation, well-being and adherence to therapy. In summary, VR could be an effective and realistic therapy option for acute and chronic pain in clinical and home settings in the future.
The State of Science in the Use of Virtual Reality in the Treatment of Acute and Chronic Pain: A Systematic Scoping Review. [2023]Previous reviews have reported virtual reality (VR) to be an effective method to treat pain. This scoping review examines the state of the science for VR and pain both generally and by pain type (acute and chronic) related to types of mechanisms, dosage, effectiveness, and adverse events (AEs). We searched online databases PubMed, Web of Science, PsychInfo, and CINAHL from 2010 to 2020 and included studies from peer reviewed journals that examined people with pain, (excluding pain-free participants) with a primary outcome measuring pain. We assessed studies for risk of bias using PEDro criteria. We described data through counts and percentages. Significant results were determined through P-values. We found 70 studies representing 4105 people; 46 acute pain studies (65.7%), 22 chronic pain studies (31.4%), and 2 (2.9%) "both." The most common VR mechanism was distraction (78.6%) then embodiment (17.1%). However, distraction was the mechanism for 97.8% acute pain studies while embodiment was more common for chronic pain (54.5%). Dosage of VR was inconsistently reported and varied considerably. VR treatment groups showed significant improvements in pain, particularly for intensity of pain (72.1%) and quality of pain (75.0%). Few studies examined AEs. Limitations of this review include only examining last 10 years of articles and that many studies were missing data. VR appears to be an effective intervention to address both acute and chronic pain. Research evaluating VR mechanisms, dosage, and AEs is warranted, as is further work in under-served populations (children for chronic pain and older adults) as the current evidence is largely limited to adult populations with pain.
Virtual Reality as an Adjunct Home Therapy in Chronic Pain Management: An Exploratory Study. [2020]Virtual reality (VR) therapy has been successfully used as an adjunct therapy for the management of acute pain in adults and children, and evidence of potential efficacy in other health applications is growing. However, minimal research exists on the value of VR as an intervention for chronic pain.
The promise and challenge of virtual gaming technologies for chronic pain: the case of graded exposure for low back pain. [2015]Virtual reality (VR) technologies have been successfully applied to acute pain interventions and recent reviews have suggested their potential utility in chronic pain. The current review highlights the specific relevance of VR interactive gaming technologies for pain-specific intervention, including their current use across a variety of physical conditions. Using the example of graded-exposure treatment for pain-related fear and disability in chronic low back pain, we discuss ways that VR gaming can be harnessed to optimize existing chronic pain therapies and examine the potential limitations of traditional VR interfaces in the context of chronic pain. We conclude by discussing directions for future research on VR-mediated applications in chronic pain.