Analysis of Hyperthermia as an Adjunctive Treatment to Evidence-based Clinical Intervention in Subjects With Bursitis: a Double-blind Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 主要终点
- DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH)
研究概览
简要总结
This project aims to analyze the use of hyperthermia within a bursitis treatment protocol, as well as to determine the difference between two and three sessions per week. Study participants will be divided into four intervention groups: the first will receive two sessions per week for a period of six months, while the second will receive three sessions per week for the same period. The treatment protocol will consist of therapeutic physical exercise focused on the affected joint, stretching of the involved muscles, and the application of hyperthermia to the bursa and surrounding areas. The third and fourth intervention groups will receive the same treatment as mentioned above, but without hyperthermia. The third group will receive three sessions per week, while the second group will receive two sessions per week. Two different types of measurement variables will be used: on the one hand, the objective variable will be measurement and assessment of the bursa using ultrasound imaging. Subjective measurement variables will also be used through validated questionnaires, which will address physical activity, perceived functional limitations, and the visual analog scale for pain perception.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis confirmed by performing an imaging test of Bursitis
- •Have not yet received physiotherapy treatment.
排除标准
- •Have undergone surgery.
- •Those who refuse to participate in this study.
- •Patients with muscle atrophy.
- •Medical conditions that are contraindications for hyperthermia therapy.
结局指标
主要结局
DISABILITIES OF THE ARM, SHOULDER AND HAND QUESTIONNAIRE (DASH)
时间窗: Baseline and up to one year
It consists of a self-administered questionnaire that assesses the upper limb as a functional unit and allows for the quantification and comparison of the impact of different processes affecting different regions of the limb. It consists of a core of 30 items and two optional modules, each with four items. Each item is scored from 1 to 5, with higher scores corresponding to greater symptom intensity. The final score can range from 30 to 150 points, with a scale of 0 (best possible score) to 100 (worst possible score). The optional modules are scored separately. The Spanish version has very high reliability (r=0.96).
LOWER EXTREMITY FUNCTIONAL SCALE (LEFS)
时间窗: This questionnaire assesses perceived functionality in patients with a musculoskeletal problem in the lower limb. It consists of 20 questions, each of which is scored by the patient, ranging from 0 (extreme difficulty or inability to perform the activity
International Physical Activity Questionnaire (IPAQ)
时间窗: Baseline and up to one year
This instrument is designed to measure physical activity levels in an adult population and can serve as a reference for making recommendations regarding physical activity. It comes in two versions: the long version with 31 items (IPAQ-LF) and the short version with 9 items (IPAQ-SF). The short version, which will be used in this study as recommended by the authors, measures activity at four intensity levels, ranging from 1 (vigorous-intensity activity) to 4 (sedentary). It has very good reliability (r=0.8).
Visual Analogue Scale (VAS)
时间窗: Baseline and up to one year
It consists of an 11-point numerical scale, ranging from 0 (no pain) to 10 (maximum pain intensity), which serves as a quantification for measuring pain intensity. It has moderate to good reliability.
Ultrasonography
时间窗: Baseline and up to one year
Ultrasound imaging techniques allow visualization of the bursa area, as the ultrasound beam can penetrate this region. These images enable detailed, multidimensional visualization of the joints and adjacent structures. They also allow precise differentiation of different tissue types, such as soft tissue, bone, or fluids. This is a noninvasive test; it involves placing the transducer on the skin surface, perpendicular to the anatomical location of the bursa.
次要结局
未报告次要终点
研究者
Dr. Manuel González-Sánchez
Principal Investigator
University of Malaga