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

16 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the idea that Virtual Reality for Sphincter of Oddi Dysfunction is an effective treatment?

The available research does not provide specific data supporting the effectiveness of Virtual Reality for Sphincter of Oddi Dysfunction. The studies focus on other treatments for this condition and discuss the challenges in diagnosing and treating it. There is some research on Virtual Reality for urinary incontinence, showing improvements in muscle function and quality of life, but these results are similar to traditional methods. More research is needed to determine if Virtual Reality is effective for Sphincter of Oddi Dysfunction. ^{1 2 3 4 5}

What safety data exists for Virtual Reality therapy?

The available research indicates that Virtual Reality (VR) therapy is generally safe across various applications. In a study involving older adults with cognitive and physical impairments, no negative side effects were reported, and participants tolerated the VR experience well. Another study on VR therapy for anxiety disorders showed a deterioration rate of 4.0%, which is comparable to other therapeutic approaches and lower than waiting list control groups. However, the safety and effectiveness of VR combined with an omnidirectional walking platform remain unclear, as further research is needed to assess these aspects. ^{6 7 8 9 10}

Is Virtual Reality a promising treatment for Sphincter of Oddi Dysfunction?

The research articles provided do not mention Virtual Reality as a treatment for Sphincter of Oddi Dysfunction. They focus on other treatments like endoscopic procedures and surgery. Therefore, there is no information to suggest that Virtual Reality is a promising treatment for this condition. ^{1 4 5 11 12}

Research Team

Simon Lo, MD

Principal Investigator

Cedars-Sinai Medical Center

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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 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]

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]

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]

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]

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]

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 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]

References

1. England pubmed.ncbi.nlm.nih.gov

Diagnosis and treatment of sphincter of Oddi dysfunction. [2017]

2. United States pubmed.ncbi.nlm.nih.gov

Improved predictors of outcome in postcholecystectomy pain. [2022]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Virtual Reality-Based Therapy in Patients with Urinary Incontinence: A Systematic Review with Meta-Analysis. [2022]

4. Hungary pubmed.ncbi.nlm.nih.gov

[Sphincter of Oddi dysfunction--prolonged medical therapy or early endoscopic sphincter ablation]. [2016]

5. Hungary pubmed.ncbi.nlm.nih.gov

[Management of Oddi sphincter dyskinesis. Results of drug therapy and sphincterotomy]. [2017]

6. England pubmed.ncbi.nlm.nih.gov

Immersive virtual reality for shoulder rehabilitation: evaluation of a physical therapy program executed with oculus quest 2. [2023]

7. United States pubmed.ncbi.nlm.nih.gov

Home-based Upper Extremity Stroke Therapy Using a Multiuser Virtual Reality Environment: A Randomized Trial. [2020]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Older Adults With Cognitive and/or Physical Impairments Can Benefit From Immersive Virtual Reality Experiences: A Feasibility Study. [2020]

9. Netherlands pubmed.ncbi.nlm.nih.gov

Deterioration rates in Virtual Reality Therapy: An individual patient data level meta-analysis. [2020]

10. England pubmed.ncbi.nlm.nih.gov

Potential of the omnidirectional walking platform with virtual reality as a rehabilitation tool. [2023]

11. Switzerland pubmed.ncbi.nlm.nih.gov

Long-term symptomatic relief following surgical sphincteroplasty for sphincter of Oddi dysfunction. [2021]

12. Hungary 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]. [2009]