NCT01087229已完成4 期
Comparative Study of the Effectiveness of an Equimolar Oxygen-nitrous Oxide Mixture During Physical Therapy for Adhesive Shoulder Capsulitis
Centre Hospitalier Universitaire de Nīmes5 个研究点 分布在 1 个国家目标入组 75 人开始时间: 2010年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 75
- 试验地点
- 5
- 主要终点
- Change in the Constant Score using treatment as compared to without treatment.
研究概览
简要总结
The purpose of this study is to determine whether or not the use of an equimolar mixture of oxygen and nitrous oxide during the physical therapy for patients suffering from frozen shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant Score) and less pain as compared to patients undergoing physical therapy without this treatment.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Affiliated with a social security system
- •Has signed the consent form
- •Patient has a painful, or initially painful but stable frozen shoulder (adhesive capsulitis): stiffening characterized by a passive loss of amplitude on three planes. This loss of amplitude is greater than or equal to 50% of controlateral amplitude when the controlateral shoulder is considered as normal. Otherwise, the loss of amplitude is greater than or equal to 50% of normal anatomical values.
- •Radiography confirms the integrity of the glenohumeral interspace.
排除标准
- •Intercurrent, evolving or unstable pathology: cancer, advanced cardio-vascular pathology, severe infection
- •The patient is taking a treatment that may interfere with the study (eg corticoids, pain killers, chemotherapy)
- •Contra-indication for physical therapy
- •Coagulopathy
- •Advanced diabetes mellitus, with neurological or joint complications
- •Contra indication for the experimental treatment
- •Pregnant or nursing women
- •Patient's mental state prevents him/her from understanding the nature of the study, its objectives and potential consequences.
- •Patient under guardianship
- •Patient is in an exclusion period determined by a previous study
- •Patient not able to follow protocol constraints or timetable
- •Medical history of local infection, polyarthritis or neuropathy that might explain the shoulder pain.
- •Absence of radiculopathy of cervical origin, of rotator cuff tears or evolving shoulder tendinopathy, of severe omarthrose
研究组 & 干预措施
equimolar oxygen-nitrous oxide mixture
Experimental
equimolar oxygen-nitrous oxide mixture
Kinesitherapy is performed with a mask by which patient inhales an equimolar oxygen-nitrous oxide mixture.
干预措施: equimolar oxygen-nitrous oxide mixture (Drug)
Placebo
Placebo Comparator
Patients randomized to this arm will have the placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Change in the Constant Score using treatment as compared to without treatment.
时间窗: fifteen days of physical therapy
The Constant score questionnaire consists of 11 questions that result in a final score ranging from 0 to 100. The higher the test result, the more normally the shoulder is functioning.
次要结局
- Change in kinetics at final session since baseline of passive glenohumeral flexion of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of passive glenohumeral abduction of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of active global lateral flexion of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of active global abduction of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of active global external rotation (ER2) of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of active global internal rotation of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of passive glenohumeral external rotation (ER1) of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of active global anterior flexion of the shoulder(Final session on Day 15)
- patient satisfaction(At each session: final session on Day 15)
- Antalgic intake(Until end of study (Day 180))
- Change in kinetics at final session since baseline of passive global anterior flexion of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of passive global lateral flexion of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of passive global external rotation (ER2) of the shoulder(Final session on Day 15)
- Change in kinetics at final session since baseline of passive global abduction of the shoulder(Final session on Day 15)
- Pain at visits(At each session: final session on Day 15)
- Pain induced during sessions(At each session: final session on Day 15)
- Functional improvement(Day 180)
- Change in the Constant Score using treatment as compared to without treatment(Day 180)
- Patient Quality of life(Day 180)
- Limitations posed to the physiotherapist activity due to patient pain at each session(At each session: final session on Day 15)
研究者
研究点 (5)
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