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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
Your vagus nerve helps control:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with VR/VNS | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| VR and VNS | Device | Participants will have Vagus nerve stimulation at the same time as a relaxing VR experience |
|
| Measure | Description | Time Frame |
|---|---|---|
| Recruitment and retention rates | The proportion of eligible participants successfully enrolled in eth study and the percentage who remain in the study until its conclusion | from enrolment to the end of treatment at 5 weeks |
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Inclusion Criteria:
Exclusion Criteria:● Inability to understand English and consent process
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| East kent Clinical trials Unit | Margate | Kent | CT9 | United Kingdom |
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| ID | Term |
|---|---|
| D059350 | Chronic Pain |
| ID | Term |
|---|---|
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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