Virtual Reality in SOD

A Prospective Pilot Study to Evaluate the Effect of Virtual Reality as a Treatment Option for Pain in Patients With Functional Pancreaticobiliary Disorder or Type 3 Sphincter of Oddi Dysfunction

Patients with classic type-3 Sphincter of Oddi dysfunction have chronic debilitating pain not amenable to pharmacologic or endoscopic therapy. Previous studies have shown benefits of virtual reality (VR) for pain management through immersive three-dimensional (3D) multisensory experiences, but only in short-term inpatient settings.

The impact of VR for chronic pain in patients with SOD III in an outpatient setting is being evaluated in this pilot study.

Study Overview

• Status: Recruiting
• Conditions: Sphincter of Oddi Dysfunction
• Intervention / Treatment: Device: Virtual Reality (Oculus Go)

Detailed Description

The pain management for type-3 Sphincter of Oddi dysfunction remains a significant clinical challenge and the current therapeutic outcome is often frustrating and may lead to addiction of opioid pain medication. Virtual reality (VR) has emerged as a viable option for pain management, but its usage has been limited to short-term inpatient clinical trials or experimental settings. In the proposed study, we will determine the long-term efficacy of VR intervention on pain management in patients with SOD type 3.

The study involves an initial screening visit and one follow-up visit at the end of the 6-week study.

The participants will receive self administered VR intervention, in additional to standard-of-care treatment for pain. The study also includes 6 weeks of monitoring period (2 weeks before, 4 weeks during, and 2 weeks after the VR intervention).

If the aims of the research are achieved, the study will demonstrate that virtual reality intervention may be used as a new method for pain management. This may lead to reduction in usage of opioid pain medication.

• Study Type: Interventional
• Enrollment (Estimated): 20
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Liliana C Bancila, PhD; Phone Number: 310.423-3872; Email: Liliana.Bancila@cshs.org

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90048
      • Recruiting
      • Cedars-Sinai Medical Center
      • Contact: Simon Lo; Phone Number: 310-423-6082; Email: simon.lo@cshs.org

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Diagnosis of chronic biliary type abdominal pain (RUQ pain, pain radiates to the right flank, scapula, or shoulder, or pain that stimulates gallbladder symptoms)
• 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
• absence of abnormal liver and pancreas chemistry or abnormal abdominal imaging
• 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
• Subjects on antidepressants for pain control should take the medication for a minimum of one month prior to the baseline assessment.
• Patients with SOD with depressive and/or anxiety disorders who receive psychopharmacologic treatment must be on stable medication dose for at least 6 weeks.
• Patients with access to a cell phone, able to speak, read, and write English will be enrolled.

Exclusion Criteria:

• Patients with evidence for acute or chronic pancreatitis, biliary stones, or bile duct strictures.
• Patients who have had prior sphincterotomy must have had the procedure at 3 months prior to the start of the study.
• Patients with a history of motion sickness and vertigo and anyone experiencing active nausea or vomiting (including pregnant women) will be excluded.
• Patients with a history of seizures or epilepsy will also be excluded to limit the theoretical risk of inducing seizures with VR.
• Presence of significant psychiatric disorders or any conditions that, in the investigator's opinion make the subject unsuitable for study participation will be reason for exclusion.
• Non-English speaking subjects or subjects unable to consent to study due to cognitive difficulty will not be included in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Virtual Reality; Every participant is provided with a VR headset	Device: Virtual Reality (Oculus Go); Participants will self-administer virtual reality intervention, in addition to standard of care treatment for pain. There will be 6 weeks of weeks of monitoring period (2 weeks before, 4 weeks during, and 2 weeks after the virtual reality intervention).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain scores	Pain scores will be measured using the Numeric Rating Scale (NRS) for at least 3 episodes each week. The NRS measures pain on a scale of 0 to 10, with 0 signifying no pain and 10 signifying the worst possible pain.	6 weeks

Collaborators and Investigators

• Sponsor: Cedars-Sinai Medical Center
• Investigators: Principal Investigator: Simon Lo, MD, Cedars-Sinai Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): August 21, 2019
• Primary Completion (Estimated): October 1, 2024
• Study Completion (Estimated): October 1, 2025

Study Registration Dates

• First Submitted: June 25, 2019
• First Submitted That Met QC Criteria: June 25, 2019
• First Posted (Actual): June 26, 2019

Study Record Updates

• Last Update Posted (Actual): December 14, 2023
• Last Update Submitted That Met QC Criteria: December 13, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Biliary Tract Diseases; Bile Duct Diseases; Biliary Dyskinesia; Common Bile Duct Diseases; Sphincter of Oddi Dysfunction
• Other Study ID Numbers: PRO00057560

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No