Effect of Different Molecular-Weight Hyaluronic Acid in the Treatment of Subdeltoid Bursitis: A Double-Blind Randomized Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 52
- 主要终点
- Shoulder Pain and Disability Index
研究概览
简要总结
The study employs a double-blind, randomized clinical trial design with 50 patients diagnosed with subdeltoid bursitis. Participants are divided into two groups: ultra-high-molecular-weight hyaluronic acid or high-molecular-weight 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.
详细描述
Evaluation indicators include pain (measured by Visual Analog Scale), 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Unilateral shoulder pain within the past 3 months
- •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
- •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
排除标准
- •Presence of infectious disease, inflammation, rheumatoid arthritis, or fracture
- •History of malignancy
- •Previous shoulder surgery
- •Sensory deficits
- •Total 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
结局指标
主要结局
Shoulder Pain and Disability Index
时间窗: Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome
A questionnaire to evaluate the severity of shoulder pain and disability in patients with shoulder problems; higher scores indicated more significant pain and disability
次要结局
- Disabilities of the Arm, Shoulder, and Hand(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(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(Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome)
- visual analog scale(Score change from baseline to 1 week, 1 months and 3 months of treatment, higher score, the better outcome)