Stellate Ganglion Block in Complex Regional Pain Syndrome

Официальное название

The Effect of Ultrasound-Guided Stellate Ganglion Block on Pain, Functionality, and Quality of Life in Type 1 Complex Regional Pain Syndrome in Stroke Patients

Обзор

The aim was to investigate the effect of Stellate Ganglion Blockade, which will be applied in addition to conventional physical therapy, on pain and functionality in patients with poststroke complex regional pain syndrome.

Подробное описание

Post-stroke complex regional pain syndrome (CRPS) is relatively common in hemiplegic upper extremity. Complex regional Pain Syndrome Type 1 is often seen without any nerve damage especially post-stroke. This musculoskeletal disorder usually effects motor improvement, quality of life and Daily living activities. Besides Presence of CRPS is thought to be challenging on the way of rehabilitation process. However, disproportionate sympthatic nervous system activation, disinhibition of the descenden neuronal pathways are the mechanisms thought to be taken place in the etiopathogenesis of CRPS, it still remains unclear. Pharmacological agents, Physical Therapy techniques, exercise and injections are used to treat CRPS. Therefore post-stroke patients have co-morbidities and multi-drug usage, it should be take into account to treat them with physical therapy agents and interventional procedures. Stellat ganglion blockade is an interventional technique that is used to break the vicious circle of symphatetic activation of upper extremity in CRPS. However to the best of our knowledge there are not any study that evaluates the effect of stellat ganglion Blockade on CPRS combining conventional physical therapy. Total of 32 patients with post-stroke CPRS are going to be participated in the study. Patients are going to be divided into two groups. Group 1 is going to receive both onventional physical therapy, exercise (10 sessions) and stellat ganglion blockade and Group 2 is going to receive just conventional physical therapy program and exercise therapy (10 sessions). Participants are going to evaluate before treatment, 2 weeks and 12 weeks after the end of the therapy sessions. Visual analog scale (VAS), Brunnstroom stages of stroke recovery (BSSR), Fugl-meyer (FMUE) and Stroke spesific quality of life (SSQoL) are used to evaluate pain, functionality and quality of life.

Вмешательства

• Процедура Stellate Ganglion Block
  The stellate ganglion is located in front of the anterior tubercle of the C6 vertebra. An ultrasound-guided intervention will be performed from the affected side and 2 cc of 1% lidocaine will be injected.

Первичные конечные точки

• Visual Analog Scale (VAS) [Срок оценки: Before treatment, 2 weeks and 12 weeks after the end of sessions]

Вторичные конечные точки (3)

• Brunnstroom stages of stroke recovery (BSSR) [Срок оценки: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions]
• Fugl-Meyer Upper Extremity (FMUE) Scale [Срок оценки: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions]
• Stroke Specific Quality of Life scale (SS-QOL). [Срок оценки: before treatment, 2 weeks and 12 weeks after the end of the therapy sessions]

Критерии участия

Критерии включения

• Volunteer male and female patients aged 18-75
• Diagnosed with Complex Regional Pain Syndrome according to the IASP 2012 Diagnostic Criteria
• Patient's pain level must be VAS >4

Критерии исключения

• Presence of existing neurological diseases other than rheumatic diseases and stroke
• General impairment
• Conditions that would constitute a contraindication to application, such as an open wound or sensory deficit in the application area
• Presence of active infection
• Presence of malignancy
• Cognitive dysfunction (mini mental test result <23)

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

Turkey (Türkiye) · 1 центр

• Ankara Bilkent City Hospital — Ankara

Публикации

• Yoo SD, Jung SS, Kim HS, Yun DH, Kim DH, Chon J, Hong DW. Efficacy of ultrasonography guided stellate ganglion blockade in the stroke patients with complex regional pain syndrome. Ann Rehabil Med. 2012 Oct;36(5):633-9. doi: 10.5535/arm.2012.36.5.633. Epub 2012 Oct 31. PMID 23185727
• Narouze S. Ultrasound-guided stellate ganglion block: safety and efficacy. Curr Pain Headache Rep. 2014 Jun;18(6):424. doi: 10.1007/s11916-014-0424-5. PMID 24760493
• Harden RN, McCabe CS, Goebel A, Massey M, Suvar T, Grieve S, Bruehl S. Complex Regional Pain Syndrome: Practical Diagnostic and Treatment Guidelines, 5th Edition. Pain Med. 2022 Jun 10;23(Suppl 1):S1-S53. doi: 10.1093/pm/pnac046. PMID 35687369
• Altas EU, Onat SS, Konak HE, Polat CS. Post-stroke complex regional pain syndrome and related factors: Experiences from a tertiary rehabilitation center. J Stroke Cerebrovasc Dis. 2020 Sep;29(9):104995. doi: 10.1016/j.jstrokecerebrovasdis.2020.104995. Epub 2020 Jul 3. PMID 32807418

Идентификаторы

NCT: NCT07129811 · TABED 1-24-804 · Ankara Bilkent City Hospital

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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