Chronic Pain (Back / Neck)VIRTAX-ADSPNCT07198737
Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients
A study testing VR and VNS in people with Chronic Pain (Back / Neck), run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Pain (Back / Neck)
- What is being tested?
- VR and VNS
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Jan 2026to 1 Aug 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 21Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
- Conditions
- Chronic Pain (Back / Neck)
- Being tested
- VR and VNS
- Keywords
- VR VNS
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR and VNSDevice
Participants will have Vagus nerve stimulation at the same time as a relaxing VR experience
| Study group | Role | What they receive |
|---|---|---|
| Treatment with VR/VNS | Experimental | Not described Receives: Device: VR and VNS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrolment to the end of treatment at 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Jan 2026
- Primary completion1 Jul 2026
- Study completion1 Aug 2026
Why it stopped: No appropriate participants could travel to the site
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Pain (Back / Neck)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- East Kent Hospitals University NHS Foundation Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07198737
- Sponsor's protocol ID
- S2024-CTU14-MH
- Acronym
- VIRTAX-ADSP
- Status last verified
- Sep 2025
- First submitted
- 22 Sep 2025
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients
- ClinicalTrials.gov ID
- NCT07198737
- Acronym / sponsor ID
- VIRTAX-ADSP / S2024-CTU14-MH
- Conditions
- Chronic Pain (Back / Neck)
- Keywords
- VR VNS
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No appropriate participants could travel to the site
- Enrolment
- 0 participants (actual)
- Lead sponsor
- East Kent Hospitals University NHS Foundation TrustOther government
- Study start
- 1 Jan 2026 (actual)
- Primary completion
- 1 Jul 2026 (actual)
- Study completion
- 1 Aug 2026 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Device feasibility
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment with VR/VNS | Experimental | Device: VR and VNS |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| VR and VNSParticipants will have Vagus nerve stimulation at the same time as a relaxing VR experience | Device | Treatment with VR/VNS |
Primary outcome
Recruitment and retention rates
Time frame: from enrolment to the end of treatment at 5 weeks
The proportion of eligible participants successfully enrolled in eth study and the percentage who remain in the study until its conclusion
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No
Related trials for Chronic Pain (Back / Neck)
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Not yet recruiting
Differences in Mechanistic Measures (Oxytocin and Cortisol) of Therapeutic Alliance Between A Talk-Based Therapy and Soft-Tissue Mobilization in Individuals With Chronic Spinal Pain
Spine, Low Back Pain
Not yet recruiting
Validating Blinding Maintenance of a Sham-Sensitization Control Design for Sensitization Acupuncture Trials
Knee Osteoarthritis; Insomnia; Cervical Spondylosis; Chronic Low Back Pain; Allergic Rhinitis
Recruiting
A Multicomponent Intervention for Patients With Lumbosacral Radiculopathy: Move-MORE
Lumbosacral Radiculopathy, Sciatica
Recruiting
Low Intensity Focused Ultrasound for Chronic Pain: High Resolution Targeting of The Human Insula
Chronic Back Pain, Chronic Pain (Back / Neck)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing VR and VNS in people with Chronic Pain (Back / Neck), run by East Kent Hospitals University NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Recruitment and retention rates (time frame: from enrolment to the end of treatment at 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.