Virtual Reality for Chronic Pain
(VR TMD EEG Trial)
Recruiting in Palo Alto (17 mi)
+1 other location
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: University of Maryland, Baltimore
Must not be taking: Antipsychotics
Disqualifiers: Neuromuscular, Cardiovascular, Neurological, others
No Placebo Group
Trial Summary
What is the purpose of this trial?This project examines, in chronic pain, the mechanisms of immersive virtual reality compared to the mechanisms of placebo hypoalgesia. The potential of developing new non-pharmacological premises for low-risk interventions for pain management is high.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications, but you cannot participate if you are using antipsychotics.
What data supports the effectiveness of the treatment Virtual Reality for Chronic Pain?
Research shows that virtual reality (VR) can effectively reduce pain intensity and improve quality of life for people with chronic pain. Studies found that VR treatments led to significant and lasting pain relief, better physical function, and reduced pain-related stress and interference in daily activities.
12345Is virtual reality generally safe for treating chronic pain?
Few studies have looked at the safety of virtual reality for pain treatment, but the available research suggests it is generally safe for humans. Some studies have reported side effects, but they are not common.
34678How does the treatment RelieVRx differ from other treatments for chronic pain?
RelieVRx is unique because it uses virtual reality (VR) to provide immersive pain relief skills training at home, which has shown to be more effective than a non-interactive sham VR experience. This approach targets the brain's cognitive and emotional processes involved in chronic pain, offering a non-drug, innovative method for managing pain with lasting benefits.
12368Eligibility Criteria
This trial is for individuals experiencing chronic pain, specifically in the jaw joint (TMJ Dysfunction). Participants should be interested in trying non-drug treatments. Details on specific inclusion and exclusion criteria are not provided.Inclusion Criteria
I am between 18 and 88 years old.
I can speak and write in English.
I have had jaw pain or dysfunction for at least 3 months.
+1 more
Exclusion Criteria
Color-blindness
Pregnancy or breast feeding
I don't have any injuries or infections that would prevent wearing a VR mask.
+16 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Active VR
Participants undergo active virtual reality intervention to assess changes in cortical excitability and clinical benefit
3 weeks
4 visits (in-person)
Sham VR
Participants undergo sham virtual reality intervention to compare with active VR effects
3 weeks
4 visits (in-person)
NH Phase
Participants undergo a non-intervention phase to assess baseline measurements
3 weeks
4 visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Participant Groups
The study is testing an immersive virtual reality system called RelieVRx against a fake VR treatment (Sham-VR) and no VR at all to understand how they affect chronic pain relief.
2Treatment groups
Experimental Treatment
Group I: Low impact TMDExperimental Treatment3 Interventions
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 0, 1, and 2a
Group II: High impact TMDExperimental Treatment3 Interventions
Other: TMD Phenotype
TMD participants will be clinically phenotyped into two between-subject groups based on their score on the Graded Chronic Pain Scale (GCPS). This group will have a GCPS grade 2b, 3, and 4.
RelieVRx is already approved in United States for the following indications:
🇺🇸 Approved in United States as RelieVRx for:
- Chronic lower back pain
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Luana CollocaBaltimore, MD
University of MarylandBaltimore, MD
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Who Is Running the Clinical Trial?
University of Maryland, BaltimoreLead Sponsor
References
Virtual Reality as a Clinical Tool for Pain Management. [2018]To evaluate the use of virtual reality (VR) therapies as a clinical tool for the management of acute and chronic pain.
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.
Three-Month Follow-Up Results of a Double-Blind, Randomized Placebo-Controlled Trial of 8-Week Self-Administered At-Home Behavioral Skills-Based Virtual Reality (VR) for Chronic Low Back Pain. [2022]Prior work established post-treatment efficacy for an 8-week home-based therapeutic virtual reality (VR) program in a double-blind, parallel arm, randomized placebo-controlled study. Participants were randomized 1:1 to 1 of 2 56-day VR programs: 1) a therapeutic immersive pain relief skills VR program; or 2) a Sham VR program within an identical commercial VR headset. Immediate post-treatment results demonstrated clinically meaningful and superior reduction for therapeutic VR compared to Sham VR for average pain intensity, indices of pain-related interference (activity, mood, stress but not sleep), physical function, and sleep disturbance. The objective of the current report was to quantify treatment effects to post-treatment month 3 and describe durability of effects. Intention-to-treat analyses revealed sustained benefits for both groups and superiority for therapeutic VR for pain intensity and multiple indices of pain-related interference (activity, stress, and newly for sleep; effect sizes ranged from drm = .56-.88) and physical function from pre-treatment to post-treatment month 3. The between-group difference for sleep disturbance was non-significant and pain-interference with mood did not survive multiplicity correction at 3 months. For most primary and secondary outcomes, treatment effects for therapeutic VR showed durability, and maintained superiority to Sham VR in the 3-month post-treatment period. PERSPECTIVE: We present 3-month follow-up results for 8-week self-administered therapeutic virtual reality (VR) compared to Sham VR in adults with chronic low back pain. Across multiple pain indices, therapeutic VR had clinically meaningful benefits, and superiority over Sham VR. Home-based, behavioral skills VR yielded enduring analgesic benefits; longer follow-up is needed.
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.
[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.
Durability of the Treatment Effects of an 8-Week Self-administered Home-Based Virtual Reality Program for Chronic Low Back Pain: 6-Month Follow-up Study of a Randomized Clinical Trial. [2022]We previously reported the efficacy of an 8-week home-based therapeutic immersive virtual reality (VR) program in a double-blind randomized placebo-controlled study. Community-based adults with self-reported chronic low back pain were randomized 1:1 to receive either (1) a 56-day immersive therapeutic pain relief skills VR program (EaseVRx) or (2) a 56-day sham VR program. Immediate posttreatment results revealed the superiority of therapeutic VR over sham VR for reducing pain intensity; pain-related interference with activity, mood, and stress (but not sleep); physical function; and sleep disturbance. At 3 months posttreatment, therapeutic VR maintained superiority for reducing pain intensity and pain-related interference with activity, stress, and sleep (new finding).
Guided relaxation-based virtual reality versus distraction-based virtual reality or passive control for postoperative pain management in children and adolescents undergoing Nuss repair of pectus excavatum: protocol for a prospective, randomised, controlled trial (FOREVR Peds trial). [2021]Virtual reality (VR) offers an innovative method to deliver non-pharmacological pain management. Distraction-based VR (VR-D) using immersive games to redirect attention has shown short-term pain reductions in various settings. To create lasting pain reduction, VR-based strategies must go beyond distraction. Guided relaxation-based VR (VR-GR) integrates pain-relieving mind-body based guided relaxation with VR, a novel therapy delivery mechanism. The primary aim of this study is to assess the impact of daily VR-GR, VR-D and 360 video (passive control) on pain intensity. We will also assess the impact of these interventions on pain unpleasantness, anxiety and opioid and benzodiazepine consumption. The secondary aim of this study will assess the impact of psychological factors (anxiety sensitivity and pain catastrophising) on pain following VR.
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