Can VR and a tiny ear ZAP ease shoulder pain and anxiety?
NCT ID NCT07198737
First seen Jun 25, 2026 · Last updated Sep 11, 2026 · Updated 3 times
Summary
This study combines virtual reality with a gentle electrical pulse on the ear (called taVNS) to help people with chronic shoulder pain who are waiting for surgery. The goal is to see if this drug-free approach can reduce pain, anxiety, and depression. Only 10 people will take part, and the main focus is on whether the study is feasible and safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- transcutaneous auricular vagus nerve stimulation (taVNS) paired with virtual reality
- What this could lead to
- If it works, this could offer a drug-free way to manage pain, anxiety, and depression before shoulder surgery.
- What could go wrong
- This is a very small early feasibility study with only 10 people, so results may not apply widely. The combination is new and may not provide meaningful relief.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Started
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Jan 2026
- Finished
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Aug 2026
- Lead sponsor
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A government agency
The lead sponsor is a government body.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Aged over 18. * Ability to understand English * Ability to provide informed consent and attend in-person sessions * Chronic shoulder pain (pain lasting for at least 6 months) waiting on surgical pathway. * Comorbid mild-to-moderate anxiety or depression * Referred by a consultant orthopaedic surgeon. * Unresponsive to conventional treatment for 6 months including antidepressants, physiotherapy, and/ or oral analgesics * Mean NRS pain score ≥ 5 on most or all days either continuously or in motion Exclusion Criteria:● Inability to understand English and consent process * History of significant neurological or psychiatric conditions unrelated to chronic pain (e.g., epilepsy, psychosis, schizophrenia). * Skin lesions or piercing or extensive tattooing of the concha or Skin disease: infection, eczema or cancer of the ears or skin in region where VR headset or taVNS would sit * Presence of active implants (e.g. cochlear implant, implanted vagus nerve stimulator, cardiac pacemaker, implantable cardioverter defibrillator (ICD) deep brain stimulations or spinal cord stimulators, ventriculoperitoneal (VP) shunt). * Inability to tolerate VR (e.g., severe motion sickness, vertigo or balance issues, claustrophobia). * Fear of heights * Active infections, significant trauma, or other acute conditions affecting the shoulder. * Pregnancy and women trying actively to conceive * Pre-existing Persistent post-surgical pain-(\>6 months) from surgeries other than shoulder replacements * On- going alcohol and/ or drug problem * Widespread chronic pain conditions (fibromyalgia, complex regional pain syndrome) * Involvement in any clinical studies within the last 28 days prior to assessment * Other therapies such as other psychological interventions for A/D and pain in the shoulder are not allowed for the period of the study and follow up unless there is a psychiatric emergency. Participants may also not be involved in any trial on pain management or related to shoulders while participating in this VR/VNS trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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East kent Clinical trials Unit
Margate, Kent, CT9, United Kingdom
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