Clinical trial NCT03999333: Virtual Reality in SOD
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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Sphincter of Oddi Dysfunction
Lead sponsor: Cedars-Sinai Medical Center
Sponsor class: OTHER
First posted: 2019-06-26
Enrollment: 16
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Pain scores
timeFrame: 6 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
Study officials:
affiliation: Cedars-Sinai Medical Center
name: Simon Lo, MD
role: PRINCIPAL_INVESTIGATOR
References: