Status:
NOT_YET_RECRUITING
Effect of Virtual Reality and Trans Auricular X-Vagus Nerve Stimulation for Anxiety and Depression in Chronic Shoulder Pain Patients
Lead Sponsor:
East Kent Hospitals University NHS Foundation Trust
Conditions:
Chronic Pain (Back / Neck)
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- ● 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.
Key Trial Info
Start Date :
November 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2026
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT07198737
Start Date
November 1 2025
End Date
August 1 2026
Last Update
September 30 2025
Active Locations (1)
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1
East kent Clinical trials Unit
Margate, Kent, United Kingdom, CT9