Effects of Hyaluronic Acid for Subdeltoid Bursitis

Официальное название

Therapeutic Effects of Hyaluronic Acid in the Treatment of Subdeltoid Bursitis

Обзор

The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: with either cross-linked hyaluronic acid or non-crossed-linked hyaluronic acid injection. All injections are guided by ultrasound. Assessments are conducted before treatment and at 1 week, 1 month, and 3 months post-treatment.

Подробное описание

Evaluation indicators include pain (measured by Visual Analog Scale, and pain threshold via pressure algometer), function (assessed by Disabilities of the Arm, Shoulder, and Hand score and Shoulder Pain and Disability Index), quality of life (using the World Health Organization Quality of Life-BREF).

Вмешательства

• Устройство Hyaluronic Acid (HA), 2 ml, single injection
  hyaluronic acid, 2ml, single injection

Первичные конечные точки

• Shoulder Pain and Disability Index [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]

Вторичные конечные точки (4)

• Disability of the Arm, Shoulder, and Hand [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]
• Range of motions of shoulder joint [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]
• World Health Organization Quality of Life [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]
• visual analog scale [Срок оценки: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome]

Критерии участия

Критерии включения

Unilateral shoulder pain within the past 2 weeks Pain during joint movements such as abduction or internal rotation At least one positive result from the following tests: Painful arc, Neer test, or Hawkins test No shoulder injections received in the past 3 months

Willingness to receive injection treatment and undergo follow-up assessments at the following time points:

Immediate (1 week after injection) Short-term (1 month after injection) Mid-term (3 months after injection)

Avoid use of anti-inflammatory painkillers during the study period as much as possible; if intolerable pain occurs, acetaminophen (provided by the researcher) will be used to relieve symptoms

Критерии исключения

Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture History of malignancy Previous shoulder surgery Sensory deficits Tendon rupture of the rotator cuff or biceps tendon Neurological disorders causing hand weakness or affecting shoulder mobility (e.g., stroke, Parkinson's disease, brachial plexus injury, peripheral neuropathy) Cognitive impairment preventing completion of questionnaires Cervical radiculopathy Diagnosed frozen shoulder (adhesive capsulitis) Psychiatric disorders Breastfeeding or pregnant women Received shoulder injection within the past 3 months, including corticosteroids, hyaluronic acid, Platelet-rich plasma, or any prolotherapy solution

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Тайвань · 1 центр

• Shin Kong Wu Ho-Su Memorial Hospital — Taipei

Идентификаторы

NCT: NCT07729527 · NSTC 114-2314-B-341-005

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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