Evaluation of the Effectiveness of Neurocognitive Therapeutic Exercise in Pain Control and Functional Recovery of the Shoulder Impingement Syndrome in Comparison With Traditional Therapeutic Exercise
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
研究概览
简要总结
It is a single-blind randomized controlled clinical trial to evaluate the effectiveness of neurocognitive therapeutic exercise in subjects affected by shoulder impingement syndrome in comparison with traditional therapeutic exercise. The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance. The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture). Each subject, randomly assigned to either neurocognitive therapeutic exercise (group 1) or traditional therapeutic exercise (group 2), will be submitted to one-hour session for three times a week for five weeks. The outcome measures used will be the Quick-DASH questionnaire, the Constant-Murley shoulder outcome score, the ASES score, a visual analogic scale (VAS) and the assessment will be performed at baseline (T0), at the end of treatment protocol (T1), at 3 months (T2) and 6 months (T3) from the end of 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
- Single (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
- •Subjects with shoulder impingement syndrome established by clinical examination, X-ray in anteroposterior, axillary and outlet views, and magnetic resonance imaging (MRI) or echography.
排除标准
- •Rotator cuff and/or subscapularis tendon partial/full-thickness tears,
- •capsulolabral pathology responsive to surgical repair,
- •congenital abnormalities of the acromion,
- •previous surgery on the affected shoulder,
- •inflammatory or neurological (systemic or local) diseases involving shoulder girdles,
- •cognitive or psychiatric disorders,
- •local tumor metastasis or application of radiotherapy,
- •acute infections or osseous tuberculosis.
研究组 & 干预措施
Traditional therapeutic exercise
The traditional exercise protocol contains mainly strengthening exercises, stretching exercises, Codman's pendulum exercises and exercises against elastic band resistance.
干预措施: Traditional therapeutic exercise (Other)
Neurocognitive therapeutic exercise
The neurocognitive exercise protocol contains ten exercises involving specific instruments (e.g., table inclined with a board with five concentric circles, sponges of various texture).
干预措施: Neurocognitive therapeutic exercise (Other)
结局指标
主要结局
changing of the Quick-DASH, the short form of the Disabilities of the Arm, Shoulder and Hand (DASH) questionnaire
时间窗: baseline (T0), five weeks (T1), three months (T2), six months (T3)
Assessment of changing of the physical ability and symptoms of the upper extremity
次要结局
- changing of the Constant-Murley shoulder outcome score(baseline (T0), five weeks (T1), three months (T2), six months (T3))
- changing of the Likert score(baseline (T0), five weeks (T1), three months (T2), six months (T3))
- changing of the American Shoulder and Elbow Surgeons (ASES) Society standardized shoulder assessment form (ASES) score(baseline (T0), five weeks (T1), three months (T2), six months (T3))
- changing of the visual analogic scale (VAS)(baseline (T0), five weeks (T1), three months (T2), six months (T3))
研究者
Carlo Bertolini
Principal Investigator
Catholic University of the Sacred Heart