Transcutaneous Auricular Vagus Nerve Stimulation Added to Rehabilitation for Complex Regional Pain Syndrome Type I

Официальное название

Effectiveness of Transcutaneous Auricular Vagus Nerve Stimulation Added to Standard Rehabilitation in Patients With Complex Regional Pain Syndrome Type I: A Randomized Controlled Trial

Обзор

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.

Подробное описание

Complex regional pain syndrome type I is a disabling condition that may develop after trauma, fracture, surgery, or immobilization. It is characterized by pain that is disproportionate to the initial injury and may be accompanied by sensory, autonomic, motor, edema, and trophic abnormalities. Despite multidisciplinary rehabilitation and pharmacological treatment, some patients continue to experience persistent pain and functional impairment.

Transcutaneous auricular vagus nerve stimulation is a non-invasive neuromodulation method that stimulates auricular regions innervated by the vagus nerve. It may affect pain processing, autonomic nervous system regulation, central sensitization, and neuroinflammatory mechanisms that may contribute to CRPS-I. Evidence regarding the clinical effectiveness of taVNS in this patient population remains limited.

The primary objective of this study is to determine whether active taVNS added to standard rehabilitation provides greater pain reduction than sham taVNS added to the same rehabilitation program. Secondary objectives are to compare the effects of the interventions on CRPS clinical severity, edema-related hand and wrist circumference measurements, hand function, activities of daily living, health-related quality of life, anxiety and depression symptoms, and perceived stress.

Participants will be randomly allocated in a 1:1 ratio to standard rehabilitation plus active taVNS or standard rehabilitation plus sham taVNS. Both groups will receive an identical 4-week rehabilitation program. Active and sham stimulation will be delivered with the same session duration and frequency. Participants and the outcomes assessor will be blinded to group allocation. The physiotherapist administering the stimulation will be aware of the allocation and will not participate in outcome assessments. Treatment effects and their persistence will be evaluated at weeks 4, 8, and 12.

Вмешательства

• Устройство Active Transcutaneous Auricular Vagus Nerve Stimulation
  Active transcutaneous auricular vagus nerve stimulation will be applied to the auricular concha region for 30 minutes per session, 5 days per week for 4 weeks, for a total of 20 sessions. Stimulation intensity will be individually adjusted to produce a tolerable paresthesia without pain. The intervention will be administered by a trained physiotherapist in addition to the standard rehabilitation program.
• Устройство Sham Transcutaneous Auricular Vagus Nerve Stimulation
  Sham transcutaneous auricular vagus nerve stimulation will be administered using the same device, session duration, and treatment schedule as active taVNS: 30 minutes per session, 5 days per week for 4 weeks, for a total of 20 sessions. The electrode placement and/or stimulation parameters will be configured according to a prespecified sham protocol intended not to produce therapeutic vagal stimulation. The sham intervention will be administered by a trained physiotherapist in addition to the st
• Другое Standard Rehabilitation Program
  All participants will receive the standard physical therapy and rehabilitation program routinely used in our clinic for patients with CRPS-I and based on current literature. The program will include contrast baths, transcutaneous electrical nerve stimulation, desensitization techniques, passive and active range-of-motion exercises, isometric and isotonic strengthening exercises, progressive loading exercises, hand dexterity and coordination activities, and functional training focused on activiti

Первичные конечные точки

• Change in Pain Intensity Assessed With the Numerical Rating Scale [Срок оценки: Baseline and weeks 4, 8, and 12]

Вторичные конечные точки (4)

• Change in Complex Regional Pain Syndrome Severity Assessed With the CRPS Severity Score [Срок оценки: Baseline and weeks 4, 8, and 12]
• Change in Hand Circumference [Срок оценки: Baseline and weeks 4, 8, and 12]
• Change in Wrist Circumference [Срок оценки: Baseline and weeks 4, 8, and 12]
• Change in Hand Function Assessed With the Duruöz Hand Index [Срок оценки: Baseline and weeks 4, 8, and 12]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07711392 · LIV-FTR-taVNS-CRPS1-2026-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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