Efficiency of an Ambulatory Rehabilitation Program in Patients With Shoulder Degenerative Rupture of the Rotator Cuff Tendons
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 134
- 主要终点
- Shoulder Pain
研究概览
简要总结
The main objective of the research is to study the effectiveness of an ambulatory rehabilitation program based on mobilization and muscular solicitation, during painful shoulders by full-thickness degenerative rupture of the tendons of the rotator cuff. , with the algo-functional state, ie pain and activity limitation, as judgment criteria, at 3 months.
详细描述
Our hypothesis is that rehabilitation based on mobilization and muscular solicitation is effective in painful shoulder due to degenerative rupture of the tendons of the rotator cuff; that it reduces pain, functional limitation and the need for surgery.
Research Excluding health products:
Experimental group: Ambulatory rehabilitation program based on mobilization and muscular solicitation
Control group: Ambulatory rehabilitation program using of ultrasound physiotherapy
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
The experimental plan is that of therapeutic research. This is a multicenter, prospective, comparative, randomized patient study in 2 parallel arms (ratio 1: 1) in single blind, providing for 134 participants.
They can provide an unbiased evaluation of the effect of this intervention, randomisation having the effect of eliminating any influence of the patient or the doctor on the allocation of the intervention and therefore of not guiding the selection of patients according to the intervention they will receive. Conducting a double-blind trial would be impossible here. The patient and the physiotherapist will be aware of the treatment arm to which the patient belongs. However, the evaluator (who is not the therapist) will not know the treatment arm and the patient will not know the hypothesis tested (effectiveness of the rehabilitation received by the experimental group).
入排标准
- 年龄范围
- 55 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥ 55 years old,
- •Painful shoulder for at least 1 month,
- •Shoulder treated with at least one cortisone infiltration one month or more before inclusion,
- •Pain ≥ 40/100 on visual analog scale,
- •Pain reproduced by at least one clinical test of rotator cuff tendons or subacromial impingement (Jobe, Patte, Neer, Yocum test, Hawkins),
- •Full-thickness tear of at least one tendon of the rotator cuff attested by imaging,
- •Affiliation to social security
排除标准
- •Passive glenohumeral mobility of the shoulder limited,
- •Calcifying tendinopathy on standard radiography,
- •Glenohumeral arthropathy;
- •Painful acromioclavicular arthropathy;
- •History of shoulder fracture;
- •Neurogenic pain or neurogenic motor deficit of the upper limb;
- •Cortisone infiltration of the shoulder in the month preceding inclusion;
- •Operated shoulder;
- •Systemic pathologies including inflammatory rheumatism or neoplastic pathology;
- •Patient participating in another experimental research;
- •Patient under legal protection (curators or guardianship)
- •Patient deprived of liberty by a judicial or administrative decision
- •Pregnant or breastfeeding woman
结局指标
主要结局
Shoulder Pain
时间窗: At 3 month follow-up
algo-functional scorec SPADI, measured with Visual Analog Score
Shoulder disability
时间窗: At 3 month follow-up
algo-functional score SPADI, measured with Visual Analog Score
次要结局
- Shoulder active mobility(3, 6, 12 months)