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Идёт набор NCT06653855

The Effect of Cupping on Spasticity and Function of the Lower Extremity During Rehabilitation After Stroke

Без фазы С лечением Stroke Gait Rehabilitation

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: Dry Static Cupping, Placebo cupping, Standard physical therapy treatment.
Кому может быть актуально
Состояния в реестре: Stroke Gait Rehabilitation. Базовые параметры: 30 лет — 80 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
США
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Обзор

Physical therapists use dry static cupping for the treatment of many conditions, including spasticity for patients post-stroke. While research better describes the effects of dry static cupping for patients with orthopedic conditions, information is lacking on central conditions, such as stroke and resulting spasticity.

Подробное описание

Cupping is an ancient alternative medicine. A common form of cupping, called dry static cupping, involves creating negative pressure inside a therapeutic cup. The cup is then placed on the skin, creating a light suction effect. In Eastern Medicine, cupping has been used to treat a variety of diseases. More recently, in Western society, cupping has been used after injury, and among other effects, has been found to improve blood volume and tissue oxygenation to an area. These effects have originally been thought to be peripheral in nature, occurring at the cupping site, hence, why cupping has been used for treatment for conditions like carpal tunnel syndrome, spinal pain, knee osteoarthritis, and other musculoskeletal conditions.

However, a recent systematic review found cupping to be beneficial for rehabilitation after stroke. These conclusions raise the question of a possible mechanism for cupping to improve impairments related to the central nervous system, such as spasticity after stroke. However, many of the studies to date have serious methodological flaws that limit the direct causation of cupping to the reduction of spasticity. As well, the majority of studies only involve the upper extremity. No study has yet looked at the therapeutic effects of dry static cupping on lower extremity spasticity reduction after stroke.

Вмешательства

  • Другое Dry Static Cupping
    A myofascial decompression cupping set with a precision pressure pump will be used to perform dry static cupping to the adductor and hamstring muscle groups of the affected limb, using a negative pressure of 300mmHg for eight minutes each.
  • Другое Placebo cupping
    The same protocol will be used as stated for the Dry static cupping intervention, with the only difference being that the cup will be pumped to 50mmHg instead of 300mmHg.
  • Другое Standard physical therapy treatment
    Treatment will consist of typical physical therapy interventions performed for patients with spasticity of the lower extremity after stroke. These may include, but not be limited to: * Balance exercise * Therapeutic exercise * Neuromuscular/muscular coordination exercise * Manual (hands on) therapy * Gait training The treating physical therapist is left with the autonomy of the standard physical therapy treatment (within the above stated groups of interventions) because patients with the diagn

Первичные конечные точки

  • Modified Ashworth Scale [Срок оценки: At enrollment and then at 1, 2, and 3 months of treatment.]
Вторичные конечные точки (3)
  • Six-Minute Walk Test (6MWT) [Срок оценки: At enrollment and then at 1, 2, and 3 months of treatment.]
  • Timed Up and Go (TUG) Test [Срок оценки: At enrollment and then at 1, 2, and 3 months of treatment.]
  • Berg Balance Scale (BBS) [Срок оценки: At enrollment and then at 1, 2, and 3 months of treatment.]

Критерии участия

Критерии включения

  • Age 30-80
  • Acute stroke (within 6 months of stroke), with spasticity \& hemiparesis of LE
  • Referred by doctor for rehabilitation for a stroke-related condition
  • Attending Ascension Rehabilitation of Joliet for rehabilitation
  • Able to read or verbally understand English or Spanish

Критерии исключения

  • Absent sensation of the areas to be cupped
  • Significant cognitive impairment
  • Pregnancy
  • Prescription anticoagulant medications
  • Blood clotting disorder
  • Uncontrolled hypertension
  • Uncontrolled diabetes
  • Open wounds within the cupping area
  • Current DVT
  • Hematoma over the cupping area
  • Fracture over the cupping area
  • Active cancer within the cupping area
  • Current use of Baclofen
  • Current use of Botox
  • Current use of an anti-spasticity medication

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
Тройное слепое
Основная цель
Лечение

Центры проведения

США · 1 центр
  • Ascension Rehabilitation of Joliet — Joliet

Публикации

  • Kim M, Han C ho. The effectiveness and safety of cupping therapy for stroke survivors: A systematic review and meta-analysis of randomized controlled trials. J Korean Med. 2021;42(4):75-101. doi:10.13048/jkm.21039
  • Choi TY, Ang L, Ku B, Jun JH, Lee MS. Evidence Map of Cupping Therapy. J Clin Med. 2021 Apr 17;10(8):1750. doi: 10.3390/jcm10081750. PMID 33920643
  • Pontes NS, Barbosa GM, Almeida Silva HJ, Scattone Silva R, Souza CG, Lins CAA, de Souza MC. Effects of dry cupping on pain, function and quality of life in women with knee osteoarthritis: a protocol for a sham-controlled randomised trial. BMJ Open. 2020 Dec 24;10(12):e039857. doi: 10.1136/bmjopen-2020-039857. PMID 33361075
  • Shen WC, Jan YK, Liau BY, Lin Q, Wang S, Tai CC, Lung CW. Effectiveness of self-management of dry and wet cupping therapy for low back pain: A systematic review and meta-analysis. Medicine (Baltimore). 2022 Dec 23;101(51):e32325. doi: 10.1097/MD.0000000000032325. PMID 36595746
  • Michalsen A, Bock S, Ludtke R, Rampp T, Baecker M, Bachmann J, Langhorst J, Musial F, Dobos GJ. Effects of traditional cupping therapy in patients with carpal tunnel syndrome: a randomized controlled trial. J Pain. 2009 Jun;10(6):601-8. doi: 10.1016/j.jpain.2008.12.013. Epub 2009 Apr 19. PMID 19380259
  • Kim JI, Lee MS, Lee DH, Boddy K, Ernst E. Cupping for treating pain: a systematic review. Evid Based Complement Alternat Med. 2011;2011:467014. doi: 10.1093/ecam/nep035. Epub 2011 Jun 23. PMID 19423657
  • Al-Bedah A, Aboushanab TS, Alqaed M, et al. Classification of Cupping Therapy: A Tool for Modernization and Standardization. J Complement Altern Med Res. 2016;1(1):1-10. doi:10.9734/JOCAMR/2016/27222
  • Qureshi NA, Ali GI, Abushanab TS, El-Olemy AT, Alqaed MS, El-Subai IS, Al-Bedah AMN. History of cupping (Hijama): a narrative review of literature. J Integr Med. 2017 May;15(3):172-181. doi: 10.1016/S2095-4964(17)60339-X. PMID 28494847

Идентификаторы

NCT: NCT06653855 · RIL20240041

Первоисточники (государственные реестры)

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