Loading
VR and VNS / Chronic Pain (back / Neck) · Interventional Study
ClinicalTrials.gov · September 10, 2026
Early or partial results. Treat as a signal, not a conclusion.
This is a registry record for a withdrawn feasibility study that combined transcutaneous auricular vagus nerve stimulation (taVNS) with virtual reality for chronic shoulder pain management. No results are reported; the study aimed to assess trial feasibility (recruitment, retention, compliance) as a precursor to evaluating clinical efficacy for pain, anxiety, depression, and quality of life in patients awaiting surgery.
Interventional, Single Group, Open label, Device Feasibility purpose. Chronic Pain (Back / Neck); age from 18 Years. Intervention: Treatment with VR/VNS. 1 site: United Kingdom.
Primary outcome measures were recruitment and retention rates over 5 weeks of treatment. Study paired taVNS (electrical stimulation to vagus nerve via outer ear) with relaxing VR environment designed to aid breathing control. Secondary aims included assessment of pain reduction, psychological well-being, and quality of life, but no data are reported.
No safety or adverse event data provided.
No clinical guidance can be drawn from this registry record. The study was withdrawn before completion and no efficacy or safety data are available. Clinicians should not use this as evidence for taVNS or VR combined therapy pending publication of completed trials.
This is a withdrawn feasibility study registration with no results posted; it assessed recruitment, retention, and compliance rather than clinical efficacy, making it a pre-efficacy phase record.
As stated by the source record.
Quoted from the source exactly as published.
No clinical guidance can be drawn from this registry record. The study was withdrawn before completion and no efficacy or safety data are available. Clinicians should not use this as evidence for taVNS or VR combined therapy pending publication of completed trials.
Graded across the dimensions that decide whether you should act, each from what the source actually supports. There is no single score, and where a dimension was not assessed it says so.
Registry record from ClinicalTrials.gov (NCT07198737). This is a study registration, not published results. Lead sponsor: East Kent Hospitals University NHS Foundation Trust. Recruitment status: WITHDRAWN. Phase: NA. Study type: INTERVENTIONAL. Conditions: Chronic Pain (Back / Neck). Interventions: DEVICE: VR and VNS. Primary outcome measures: Recruitment and retention rates , from enrolment to the end of treatment at 5 weeks. Brief summary: Chronic shoulder pain is a debilitating condition that significantly impacts quality of life, daily functioning, and mental well-being. For individuals awaiting surgical intervention for a long period, prolonged pain often leads to heightened psychological distress, poor sleep quality, and reduced overall health outcomes. Innovative approaches are urgently needed to address these challenges and improve preoperative management. This study will combine 2 technologies which have both been shown to help relax and calm users. Transcutaneous Auricular Vagus Nerve Stimulation (taVNS) is * a gentle non-invasive therapy that uses a small device to send tiny electrical pulses to a spot on your outer ear. The principle of using electrical pulses are similar to pacemaker or TENS machines. * These pulses help stimulate a special nerve called the vagus nerve, which is like a superhighway between your brain and your body Your vagus nerve helps control: * Your mood and anxiety levels * Healing of nerves and other organs in the body * How your body handles pain * Digestion, heart rate, and more By stimulating the vagus nerve, taVNS can help your body relax, reset, and feel better. While virtual reality (VR) has demonstrated effectiveness in distracting from pain and improving psychological resilience. These two will be combined so that the participant experiences a relaxing VR environment that helps them control their breathing while receiving taVNS. With the aim of managing chronic pain by targeting both physical and psychological dimensions. This study aims to evaluate the feasibility and safety, of a trial of taVNS paired with VR looking at trial recruitment, retention and compliance. Secondary to this the study will look to see if there is evidence of taVNS +VR in reducing pain, enhancing psychological well-being, and improving quality of life for individuals with chronic shoulder pain awaiting surgery. It will provide critical insights into the potential of this combined intervention as a preoperative and potentially post operative pain management strategy.
Taken from the source record, never inferred. Follow any of these and new work involving them reaches your briefing.