What side effects are associated with this type of intervention?

Common treatments for Sphincter of Oddi Dysfunction (SOD) include pharmacologic therapies, endoscopic procedures, and non-pharmacologic interventions such as virtual reality (VR) for pain management. Pharmacologic treatments can cause side effects like nausea, dizziness, and gastrointestinal disturbances. Endoscopic procedures may lead to complications such as pancreatitis, infections, and bleeding. VR for pain management, while generally considered safe, may cause transient side effects like motion sickness, dizziness, and eye strain. Overall, VR offers a promising non-invasive option with fewer severe side effects compared to traditional treatments.

What prior FDA approvals exist?

There are no specific FDA-approved drugs exclusively for the treatment of Sphincter of Oddi Dysfunction (SOD). Traditional treatments for SOD often include pharmacologic therapies such as antispasmodics, pain management medications, and endoscopic procedures. The innovative approach of using Virtual Reality (VR) for pain management, as studied in the trial, represents a novel, non-pharmacologic method aimed at providing relief through immersive 3D multisensory experiences. This method is still under investigation and has not yet received FDA approval for SOD treatment.

What other types of research exist?

Promising novel alternatives to Virtual Reality for pain management in Sphincter of Oddi Dysfunction patients include: 1) Neuromodulation techniques such as noninvasive median and radial nerve stimulation, which have shown efficacy in reducing pain in other conditions. 2) Myofascial trigger point release combined with paradoxical relaxation training, which has been effective in chronic pelvic pain syndromes. 3) Acupuncture, which has demonstrated benefits in chronic pain management. 4) Cognitive Behavioral Therapy (CBT) tailored for chronic pain, which addresses the psychological aspects of pain and has shown positive outcomes in various chronic pain conditions.

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Behavioural Intervention

Virtual Reality for Sphincter of Oddi Dysfunction

N/A

Recruiting

Led By Simon Lo, MD

Research Sponsored by Cedars-Sinai Medical Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Average pain score of greater than or equal to 3 out of 10 on the numeric rating scale (NRS) for at least the average of 3 episodes each week

Pancreatic pain (epigastric or left upper quadrant pain, pain that is exacerbated by some food, or pain that radiates to the back) for at least 3 months prior to the study

Must not have

Patients with evidence for acute or chronic pancreatitis, biliary stones, or bile duct strictures

Patients with a history of seizures or epilepsy will also be excluded to limit the theoretical risk of inducing seizures with VR

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 weeks

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing if virtual reality (VR) can help manage chronic pain in patients with type-3 Sphincter of Oddi dysfunction (SOD III). These patients often do not respond to usual treatments and risk opioid addiction. VR creates an engaging 3D experience that distracts the brain from pain. The study aims to see if this method can reduce pain and lower opioid use. Virtual reality (VR) has been shown to effectively manage both acute and chronic pain by providing cognitive distractions and potentially reducing opioid use.

Who is the study for?

This trial is for adults with chronic pain from Sphincter of Oddi Dysfunction (SOD) who haven't found relief through usual treatments. They should not have liver, pancreas, or bile duct issues and must be stable on any antidepressants or psychopharmacologic drugs for at least one month. Participants need to speak English and have access to a cell phone.

What is being tested?

The study tests if Virtual Reality (VR) using Oculus Go can help manage chronic pain in outpatient settings for those with type-3 SOD. It aims to see if immersive VR experiences can reduce the intensity of their ongoing abdominal pain.

What are the potential side effects?

Since this intervention involves VR technology, potential side effects may include motion sickness or vertigo, especially in individuals prone to these conditions. However, such risks are generally low.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My average pain score is 3 or more on a scale of 10.

Select...

I have had pancreatic pain for at least 3 months.

Select...

My liver, pancreas, and abdomen scans are normal.

Select...

I have chronic pain in my upper right abdomen that may spread to my back or shoulder.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have had pancreatitis, gallstones, or bile duct issues.

Select...

I have never had seizures or epilepsy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pain scores

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Virtual RealityExperimental Treatment1 Intervention

Every participant is provided with a VR headset

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Sphincter of Oddi Dysfunction (SOD) include pharmacologic therapies, endoscopic procedures, and non-pharmacologic interventions like Virtual Reality (VR). Pharmacologic treatments often involve muscle relaxants and pain relievers to reduce sphincter spasms and alleviate pain. Endoscopic procedures, such as sphincterotomy, aim to relieve obstruction by cutting the sphincter muscle. VR, as an emerging non-pharmacologic treatment, provides immersive 3D multisensory experiences that can distract patients from chronic pain, potentially reducing their perception of pain without the need for medication. This matters for SOD patients as it offers a non-invasive, drug-free option for managing chronic pain, which can improve their quality of life and reduce reliance on pharmacologic treatments.

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