Transcutaneous Auricular Vagus Nerve Stimulation Added to Rehabilitation for Complex Regional Pai… (NCT07711392) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Transcutaneous Auricular Vagus Nerve Stimulation Added to Rehabilitation for Complex Regional Pain Syndrome Type I
20 participantsStarted 2026-07-15
Plain-language summary
This randomized, participant- and assessor-blinded, sham-controlled study will evaluate the effectiveness of transcutaneous auricular vagus nerve stimulation (taVNS) added to standard rehabilitation in adults with complex regional pain syndrome type I (CRPS-I) affecting the hand or upper extremity.
A total of 20 participants will be randomly assigned to two parallel groups. Both groups will receive the same standard rehabilitation program 5 days per week for 4 weeks. In addition, the experimental group will receive active taVNS, while the control group will receive sham taVNS for 30 minutes per session over the same 4-week period.
The primary outcome is change in pain intensity measured using the Numerical Rating Scale. Secondary outcomes include CRPS clinical severity, hand and wrist circumference, hand function and activities of daily living, health-related quality of life, anxiety and depression symptoms, and perceived stress. Assessments will be performed at baseline, at the end of treatment at week 4, and during follow-up at weeks 8 and 12.
Who can participate
Age range
18 Years – 65 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Diagnosis of complex regional pain syndrome type I according to the Budapest diagnostic criteria
* Age 18 to 65 years
* CRPS type I affecting the hand following a traumatic cause, including surgery, fracture, and/or immobilization of the hand or upper extremity
* Willingness to participate in the study and provision of written informed consent
Exclusion Criteria:
* Diagnosis of complex regional pain syndrome type II
* CRPS type I developing after stroke
* Acute or post-acute rehabilitation following hand tendon repair
* Presence of a comorbid condition that may substantially affect functional status or health-related quality of life, including decompensated heart failure, chronic kidney failure, or malignancy
* Arthritis affecting the hand
* Acute arterial or venous thrombosis of the upper extremity
* History of arterial or venous injury of the upper extremity
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Pain Intensity Assessed With the Numerical Rating Scale