Virtual Reality for Sphincter of Oddi Dysfunction

Overseen By Liliana C Bancila, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Cedars-Sinai Medical Center

Must be taking: Antidepressants

Disqualifiers: Pancreatitis, Biliary stones, Seizures, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores virtual reality (VR) therapy to manage chronic pain in individuals with type-3 Sphincter of Oddi dysfunction (SOD III). SOD III causes ongoing upper abdominal pain similar to gallbladder or pancreatic pain, which usual treatments do not relieve. Participants will receive a VR headset to determine if this technology can ease pain in everyday life, beyond a hospital setting. This trial may suit individuals who have experienced this specific pain for at least three months, have normal liver and pancreas test results, and endure significant weekly pain. As an unphased trial, it offers a unique opportunity to explore innovative pain management solutions using VR technology.

Do I have to stop taking my current medications for the trial?

The trial does not specify if you need to stop taking your current medications. However, if you are on antidepressants for pain control, you should have been taking them for at least one month before the trial. If you are receiving treatment for depressive or anxiety disorders, your medication dose must be stable for at least 6 weeks before the trial.

What prior data suggests that virtual reality is safe for pain management?

Research has shown that virtual reality (VR) can help reduce pain. Studies have found that VR experiences can lower pain levels and sometimes even reduce the need for pain medication. Most people tolerate VR well, with few reports of negative side effects.

While more long-term information is needed, early results suggest that using VR for pain management in conditions like Sphincter of Oddi dysfunction (SOD) appears promising. In these studies, no major negative effects were reported, indicating that VR could be a safe option for managing chronic pain.

For those considering joining a trial using VR for pain management, current evidence suggests it is a low-risk treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about using Virtual Reality (VR) for Sphincter of Oddi Dysfunction because it offers a novel, non-invasive approach to pain management. Unlike traditional treatments such as medication or surgery, VR immerses patients in a virtual environment that can help distract and potentially reduce their perception of pain. This innovative use of technology could provide a safer alternative with fewer side effects compared to current standard care options. By engaging the brain in a different way, VR may open new pathways for relief, which is why it's generating excitement in the medical community.

What evidence suggests that virtual reality is effective for managing chronic pain in Sphincter of Oddi dysfunction?

Research has shown that virtual reality (VR) can help manage pain in people with Sphincter of Oddi Dysfunction (SOD), especially type-3. Studies have found that VR reduces the need for pain medicine during medical procedures and eases pain related to SOD. One study demonstrated that VR lowered pain and even reduced the need for opioids, which are strong painkillers. This is promising because patients with SOD often experience chronic pain that doesn't improve with regular treatments. In this trial, every participant will receive VR therapy to evaluate its long-term effectiveness for patients who are not in the hospital. ^{1 2 3 5 6}

Who Is on the Research Team?

Simon Lo, MD

Principal Investigator

Cedars-Sinai Medical Center

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

I have been taking antidepressants for pain for at least one month.

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

I have been on a stable dose of medication for my depression or anxiety for at least 6 weeks.

Exclusion Criteria

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

Non-English speaking subjects or subjects unable to consent to study due to cognitive difficulty will not be included in the study

Patients with a history of motion sickness and vertigo and anyone experiencing active nausea or vomiting (including pregnant women) will be excluded

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 visit

Treatment

Participants receive self-administered VR intervention in addition to standard-of-care treatment for pain

4 weeks

Self-administered

Monitoring

Participants are monitored for pain scores using the Numeric Rating Scale (NRS) for at least 3 episodes each week

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 visit

What Are the Treatments Tested in This Trial?

Interventions

• Virtual Reality

Trial Overview 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.

How Is the Trial Designed?

Group I: Virtual Reality Experimental Treatment 1 Intervention

Every participant is provided with a VR headset

Virtual Reality is already approved in United States for the following indications:

Approved in United States as Virtual Reality Therapy for:

• Functional Dyspepsia
• Irritable Bowel Syndrome (IBS)
• Gastroparesis

Who Is Running the Clinical Trial?

Cedars-Sinai Medical Center

Lead Sponsor

Trials

523

Recruited

165,000+

Published Research Related to This Trial

In a study involving 20 stroke survivors, multiuser virtual reality (MU VR) therapy led to significantly greater arm movement (414.6m) compared to single-user (SU VR) therapy (327.0m), indicating that MU VR may enhance physical engagement during rehabilitation.

Participants showed high compliance with both therapy modes (99% for MU and 89% for SU), and overall motor recovery, as measured by the Fugl-Meyer Assessment, improved significantly across all participants, suggesting that MU VR can effectively extend clinical therapy into home settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. Thielbar, KO., Triandafilou, KM., Barry, AJ., et al.[2020]

A study involving 66 older adults (average age 80.5) demonstrated that immersive Virtual Reality (VR) therapy is feasible and safe for individuals with varying cognitive and physical impairments, with no reported negative side effects.

Participants generally found the VR experience enjoyable and relaxing, with 76% expressing a desire to try it again, indicating its potential as a non-pharmacological intervention to improve well-being in older adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. Appel, L., Appel, E., Bogler, O., et al.[2020]

In a study involving 810 patients, Virtual Reality (VR) treatment for anxiety disorders showed a low deterioration rate of 4.0%, which is comparable to the 2.8% in active control conditions and significantly better than the 15% deterioration rate in waiting list (WL) controls.

The study found that socio-demographic factors did not significantly influence deterioration rates, except for marital status, where married individuals in the WL condition had a lower likelihood of deterioration, indicating that VR is a safe treatment option with similar outcomes to other therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Deterioration rates in Virtual Reality Therapy: An individual patient data level meta-analysis. Fernández-Álvarez, J., Rozental, A., Carlbring, P., et al.[2020]

In a study of 29 patients with sphincter of Oddi dysfunction, endoscopic findings were positive in 86.2% of cases, revealing conditions like adenoma and papillitis, which were confirmed by histopathology in 12 patients.

The study suggests that early endoscopic sphincter ablation can be beneficial for patients who do not respond to medical treatment, potentially preventing the progression of this functional disorder into a more serious, precancerous condition.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Sphincter of Oddi dysfunction--prolonged medical therapy or early endoscopic sphincter ablation]. Kovács, F., Gyökeres, T., Elek, G., et al.[2016]

Surgical sphincteroplasty (SS) provided significant pain relief for patients with sphincter of Oddi dysfunction, with a median follow-up of 5.1 years showing a reduction in pain scores from 67 to 16 (p = 0.003).

The study found that morphine provocation hepatic scintigraphy was highly effective in identifying patients who would benefit from SS, achieving a 100% positive predictive value, indicating that manometry may not be necessary for diagnosis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term symptomatic relief following surgical sphincteroplasty for sphincter of Oddi dysfunction. Roberts, KJ., Ismail, A., Coldham, C., et al.[2021]

Endoscopic and surgical treatments for sphincter of Oddi dysfunction show similar outcomes, but both have considerable failure rates, highlighting the challenges in accurately diagnosing the condition.

The difficulties in diagnosis and the potential for sphincter of Oddi dysfunction to be part of a broader gastrointestinal motility disorder complicate the selection of appropriate patients for treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Diagnosis and treatment of sphincter of Oddi dysfunction. Tzovaras, G., Rowlands, BJ.[2017]

In a study of 74 patients with postcholecystectomy pain followed for an average of 36 months, specific predictors such as intermittent pain, nausea or vomiting, and a pain-free interval of at least one year after cholecystectomy were identified as indicators of a positive response to sphincterotomy treatment.

When two or three of these predictors were present, 85% of Type 2 SOD patients and 56% of Type 3 patients experienced significant improvement, suggesting that these clinical features can help identify which Type 3 patients may benefit from surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Improved predictors of outcome in postcholecystectomy pain. Topazian, M., Hong-Curtis, J., Li, J., et al.[2022]

A study involving 11 physiotherapists found that a VR physical therapy program for shoulder rehabilitation using the Oculus Quest 2 was deemed safe, easy to wear, and easy to control, indicating strong acceptability among professionals.

While 73% of physiotherapists found the VR application entertaining, only 45% believed patients could use it independently, suggesting that further development is needed to enhance patient autonomy in VR rehabilitation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immersive virtual reality for shoulder rehabilitation: evaluation of a physical therapy program executed with oculus quest 2. Longo, UG., Carnevale, A., Andreoli, F., et al.[2023]

A preliminary study involving 35 participants found that using virtual reality with an omnidirectional walking platform (ODWP) for rehabilitation is perceived as relatively safe (mean score of 78.9/100) and has moderate acceptance (64.5/100).

However, 71% of participants reported experiencing mild to moderate cybersickness, indicating that while the technology shows promise, further improvements are needed to enhance user comfort and acceptance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Potential of the omnidirectional walking platform with virtual reality as a rehabilitation tool. Soon, B., Lee, N., Lau, J., et al.[2023]

Endoscopic sphincterotomy (EST) for treating hypertonic sphincter of Oddi dyskinesia (HOD) has a significantly higher complication rate (40%) compared to EST performed for bile duct stone removal (5.9%), indicating that this treatment may be riskier for patients with HOD.

Patients with non-dilated bile ducts experienced a much higher rate of complications (42.5%) compared to those with dilated bile ducts (3.3%), suggesting that the anatomical condition of the bile duct plays a critical role in the safety of EST procedures.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of hypertensive dyskinesia of Oddi's sphincter. Correlation between the frequency of complications from endoscopic sphincterotomy and the diameter of the common bile duct]. Simon, L., Döbrönte, Z., Patai, A.[2009]

Virtual reality-based pelvic floor muscle training (PFMT) shows promise in improving muscle function and quality of life for patients with urinary incontinence, but the evidence is limited to only two randomized controlled trials involving 79 patients.

The meta-analysis indicated that traditional PFMT was more effective than VR-based PFMT in reducing urinary incontinence symptoms, highlighting the need for more research to fully understand the potential of VR interventions in this area.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality-Based Therapy in Patients with Urinary Incontinence: A Systematic Review with Meta-Analysis. Rutkowska, A., Salvalaggio, S., Rutkowski, S., et al.[2022]

In a study of 64 patients with sphincter of Oddi dyskinesia, conservative treatments like nitroglycerin and calcium channel blockers were effective in achieving symptom relief for only 53% of patients.

For those who did not respond to medication, endoscopic sphincterotomy was performed in 20 cases, but only 9 out of 21 patients became symptom-free afterward, highlighting the limited effectiveness and potential complications of surgical intervention.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Management of Oddi sphincter dyskinesis. Results of drug therapy and sphincterotomy]. Döbrönte, Z., Simon, L., Patai, A.[2017]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT03999333

Study Details | NCT03999333 | Virtual Reality in SOD The pain management for type-3 Sphincter of Oddi dysfunction remains a significant clinical challenge and the current therapeutic outcome is often frustrating ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12226949/

Evaluation of a virtual reality-directed brain-gut behavioural ... In gastroenterology, VR lowers endoscopic analgesia requirements and reduces pain from dyspepsia and sphincter of Oddi dysfunction.

3. trialx.com trialx.com/clinical-trials/listings/252451/virtual-reality-in-sod/

Virtual Reality in SOD | Clinical Research Trial Listing ... 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 ...

4. researchgate.net researchgate.net/publication/347204664_S0081_Virtual_Reality_Can_Reduce_Pain_and_Opioid_Use_in_Sphincter_of_Oddi_Dysfunction_SOD_Type_III_A_Prospective_Pilot_Study

S0081 Virtual Reality Can Reduce Pain and Opioid Use in ... Statistically significant studies demonstrating whether VR has the potential to reduce the use of opioid analgesics are needed, with pilot ...

5. mentalhealth.networkofcare.org mentalhealth.networkofcare.org/Lake/CommunityResources/ClinicalTrials/Detail/NCT03999333?keyword=%22Sphincter%20of%20Oddi%20Dysfunction%22

Lake Clinical Trial Virtual Reality in SOD - Behavioral Health 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 ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06362187

Study Details | NCT06362187 | VR Pilot for Pancreatitis This study aims to determine the feasibility of a home-based, standardized, gut-directed, VR CBT for patients with CP pain as well as investigate the ...