Ultrasound-guided Hydrodistension in Patients With Adhesive Capsulitis: a Randomized Interventional Study Aimed at Evaluating the Efficacy of Hospital-assisted Rehabilitation Treatment Compared to Home-based Rehabilitation Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Shoulder Pain and Disability Index (SPADI)
研究概览
简要总结
The present study aims to compare the efficacy of assisted rehabilitation treatment, in terms of improvement of pain and shoulder articulation, in patients with stage 2 adhesive capsulitis compared with unassisted home rehabilitation treatment. This evaluation is performed following the glenohumeral capsular hydrodistension procedure performed under ultrasound monitoring.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, aged between 18 and 65 years;
- •Stage 2 adhesive capsulitis of the shoulder, with diagnosis made by clinical, radiographic evaluation in two projections (antero-posterior, lateral) and ultrasound.
排除标准
- •Patients unable to give consent;
- •Pregnant women;
- •Patients with poly-drug allergies (anesthetics, corticosteroids);
- •Patients with other conditions with similar clinical picture (calcific tendinopathy, glenohumeral arthrosis, rotator cuff injury, etc...).
研究组 & 干预措施
Hospital-assisted Rehabilitation Treatment
Patients in the experimental group will undergo 10 sessions (about 2 each week) of rehabilitation treatment at the outpatient clinics of the U.O. Physical Medicine and Rehabilitation Unit of the Rizzoli Orthopedic Institute. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint.
干预措施: Hospital-assisted Rehabilitation (Other)
Hospital-assisted Rehabilitation Treatment
Patients in the experimental group will undergo 10 sessions (about 2 each week) of rehabilitation treatment at the outpatient clinics of the U.O. Physical Medicine and Rehabilitation Unit of the Rizzoli Orthopedic Institute. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint.
干预措施: Home-based Rehabilitation (Other)
Home-based Rehabilitation Treatment
Patients in the experimental group will have 10 sessions (about 2 each week) of rehabilitation treatment with exercises to be performed self-assisted at home. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint
干预措施: Hospital-assisted Rehabilitation (Other)
Home-based Rehabilitation Treatment
Patients in the experimental group will have 10 sessions (about 2 each week) of rehabilitation treatment with exercises to be performed self-assisted at home. The rehabilitation protocol consists of a series of commuting exercises and passive/active mobilization exercises of the glenohumeral joint
干预措施: Home-based Rehabilitation (Other)
结局指标
主要结局
Shoulder Pain and Disability Index (SPADI)
时间窗: 6 months
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Shoulder Pain and Disability Index (SPADI)
时间窗: Baseline (0 months)
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Shoulder Pain and Disability Index (SPADI)
时间窗: 2 months
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
Shoulder Pain and Disability Index (SPADI)
时间窗: 4 months
It consists of a self-administered questionnaire with values from 0 to 130 (0 non-painful and granted shoulder activity, 130 painful and non-granted shoulder activity) consisting of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions about the severity of the patient's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty the patient has with various activities of daily living that require the use of the upper extremities.
次要结局
- Visual Analogue Scale (VAS)(6 months)
- American Shoulder and Elbow Scale (ASES)(6 months)
- Disability of the Arm, Shoulder and Hand (DASH)(6 months)
- Disability of the Arm, Shoulder and Hand (DASH)(Baseline (0 months))
- Disability of the Arm, Shoulder and Hand (DASH)(2 months)
- American Shoulder and Elbow Scale (ASES)(2 months)
- Disability of the Arm, Shoulder and Hand (DASH)(4 months)
- Visual Analogue Scale (VAS)(Baseline (0 months))
- Visual Analogue Scale (VAS)(2 months)
- Visual Analogue Scale (VAS)(4 months)
- American Shoulder and Elbow Scale (ASES)(Baseline (0 months))
- American Shoulder and Elbow Scale (ASES)(4 months)