Functional Results of Infiltration for Biceps Tendonitis Guided by Ultrasound vs Anatomical Repairs: Variation in Technique
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- qDASH
研究概览
简要总结
A randomized clinical trial aimed at comparing the functional outcomes of brachial biceps infiltration guided by anatomical landmarks versus ultrasound guidance. Given that ultrasound guidance has shown an efficacy of 91%, this intervention could potentially be more effective in delivering medication to the target area and achieving improved therapeutic outcomes
详细描述
Shoulder pain is a frequent orthopedic complaint, with biceps long head tendinitis being a common cause leading to physical disability in the working and athletic population. Currently, there's no guideline for managing biceps tendinitis. Studying clinical outcomes post-biceps tendon sheath infiltration will aid in developing management guidelines for quick patient return to activities with minimal sequelae.
No studies in Colombia have compared clinical outcomes of biceps tendinitis patients undergoing ultrasound-guided vs anatomically guided infiltrations. This information will allow comparison with global literature, assessing differences in treatment effectiveness and socio-economic impact on the population.
Research Question:
In patients with long head biceps tendinitis, does ultrasound-guided infiltration compared to anatomically guided infiltration yield better clinical outcomes?
Theoretical Framework and State of the Art:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years or older
- •Patients with anterior shoulder pain
- •Point of maximum pain in long head bíceps tendon at the level of the bicipital groove
- •Positive speed test
- •Patients who gave informed consent and accepted follow-up
排除标准
- •Calcifying tendonitis of the biceps
- •Partial or complete rupture of the subscapularis tendon
- •Glenohumeral joint deformity
- •Rupture and/or dislocation of the tendon of the long head of the biceps.
- •Surgery and/or previous infiltrations in the biceps tendon
结局指标
主要结局
qDASH
时间窗: initial measurement before treatment administration, final measurement at 4 weeks.
The QuickDASH, published in 2005 in the Journal of Bone and Joint Surgery, is an 11-item subset of the 30-item DASH and is a self-report questionnaire in which response options are presented as 5-point Likert scales. At least 10 of the 11 items must be completed for a score to be calculated and scores range from MINIMUM 0 to 100. 0 is the minimum score and 100 is the maximum score. 0 indicates no disability and 100 indicates more severe disability. Higher scores indicate worse outcome. This score was designed to be useful in patients with any upper extremity musculoskeletal disorder.
SANE
时间窗: initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months
The Single Assessment Numeric Evaluation (SANE) is a quick assessment tool that asks patients to rate their affected joint function as a percentage of normal, where 100% represents normal function and 0% indicates completely abnormal function. Thus, the maximum score is 100%, and the minimum is 0%. A higher score reflects a better perception of function by the patient. For example, a score of 85% suggests that the patient perceives their joint function at 85% of what they consider normal. Studies have shown that initial SANE scores typically range between 40% and 60% before treatment, improving to 75% to 85% one year after therapy, depending on the condition treated.
次要结局
- Visual Analogue Scale (VAS) for Pain Assessment(initial measurement before treatment administration, follow up at 1, 2, 3 and 4 months)
- Tenderness to palpation(Time Frame initial measurement before treatment administration, final measurement at 4 months.)
- Speed Test(Time Frame initial measurement before treatment administration, final measurement at 4 months.)
- Yergason Test(initial measurement before treatment administration, final measurement at 4 months.)
- Satisfaction with treatment(final measurement at 4 months.)
- Complications(final measurement at 4 months.)