Virtual Reality in SOD

Sphincter of Oddi Dysfunction Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03999333
• Other study ID #: PRO00057560
• Status: Recruiting
• Phase: N/A
• Start date: August 21, 2019
• Est. completion date: October 2025

Study information

• Verified date: December 2023
• Source: Cedars-Sinai Medical Center
• Contact: Liliana C Bancila, PhD
• Phone: 310.423-3872
• Email: Liliana.Bancila[@]cshs.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 20
• Est. completion date: October 2025
• Est. primary completion date: October 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Sphincter of Oddi Dysfunction

Intervention

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).

Locations

Country	Name	City	State
United States	Cedars-Sinai Medical Center	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Cedars-Sinai Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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