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临床试验/NCT04690049
NCT04690049尚未招募不适用

An Innovative Therapeutic Exercise Approach Based on Load Progression Criteria for the Management of Shoulder Impingement Syndrome: a Randomized Controlled Trial

University of Malaga0 个研究点目标入组 60 人开始时间: 2025年4月最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
入组人数
60
主要终点
Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH)

研究概览

简要总结

Upper limb tendinopathies, especially the so called "shoulder impingement syndrome", is a common injury among the population. Its management usually involves active treatments, being the therapeutic progressive exercise the most important and effective modality. However, whether a certain criterion is more appropriate than another when progressing the exercise program remains unclear. We propose a new program based on progressive exercises serving as a standard approach for the management of shoulder impingement syndrome.

详细描述

Shoulder pain is a common condition affecting our society. It is estimated that between 7 and 67% of the adult population will suffer from shoulder pain at least once in their lifetime. Some research suggest that shoulder impingement syndrome (SIS) is responsible for 44 to 60% from the medical consultations regarding shoulder pain with an approximate prevalence of 70-200 per 1000 adults, which implies a remarkable use of health care resources.

Among all the musculoskeletal injuries affecting the shoulder complex, SIS remains as the most common condition, characterized for leading to loss function and disability. Its pathogenesis is associated with the affection of diverse structures and tissues like the subacromial bursa, rotator cuff tendons, acromion, coracoacromial ligament and the long head of biceps brachii. The etiology of this condition comprises multiple causes, including capsular tightness, alteration of shoulder kinematics with scapula dysfunction and muscle imbalance, and also the overuse factor.

Treatment modalities to deal with SIS embrace both surgical procedures, i.e., arthroscopic subacromial decompression) and conservative approaches (i.e., physical therapy), becoming the therapeutic exercise increasingly popular due to arising evidence from the last 30 years. Furthermore, with regard to potential effects, therapeutic exercise presents itself as a safer and less aggressive alternative, causing fewer adverse effects than pharmacological or surgical options, which are relegated preferably as secondary choices.

There is a wide evidence supporting the exercise therapy as an effective strategy for the management of SIS. However, some controversy exists regarding the optimal approach in terms of intensity, frequency and number of repetitions. Thus, a program acting as a gold standard for the development and progression of the proposed exercises is still lacking, especially when attempting to estimate the pure effect of progressive exercise in isolation between experimental and control group.

Prior research evaluating the effect of progressive exercise for the management of SIS usually included programs with a duration of 3 months. However, other studies established follow-up periods of either one month and a half or, conversely, more than 6 months. That, together with the wide variety of post-treatment follow-ups, makes it difficult to find the optimal period where the results derived inherently from the intervention and not from the natural course of the condition may be observed.

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 (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects older than 18 years.
  • Subjects previously diagnosed with shoulder impingement syndrome.
  • Presence of 3 of the following sings: impingement sign according to Neer and to Hawking-Kennedy, positive result on Jobes test, painful arc, and positive result on Patte's manoeuvre.

排除标准

  • Findings of spinal radiculopathy.
  • General neck and shoulder pain.
  • Symptoms of frozen shoulder.
  • Pregnancy.
  • Fybromyalgia.
  • Suspected polyarthritis.
  • Chronic pain syndrome.
  • Altered blood coagulation.
  • Consumption of anticoagulants, opioids or antiepileptics.
  • Drug intakes.
  • Alcohol intakes higher than 27.4 grams for men or 13.7 grams for women.
  • Allergies.

结局指标

主要结局

Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH)

时间窗: 14 weeks

Functional scores from Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Score ranges from 0 (no disability) to 100 (most severe disability)

Change from baseline in Function measured with Constant-Murley Score (CMS)

时间窗: 14 weeks

Functional scores from Constant-Murley Score (CMS) Constant-Murley score (CMS) is a 100-points scale: the higher the score, the higher the quality of the function.

Change from baseline in Function measured with Upper Limb Functional Index (ULFI)

时间窗: 14 weeks

Functional scores from Upper Limb Functional Index (ULFI) Score ranges from 0 (no disability) to 25 (most severe disability)

Change from baseline Range of motion (ROM)

时间窗: 14 weeks

Active shoulder joint ROM (flexion, extension, abduction, internal/external rotations) by goniometry

Change from baseline Subacromial Space

时间窗: 14 weeks

Measurement of subacromial space by ultrasonography

Change from baseline Painful Sensation

时间窗: 14 weeks

Pain scores from Visual Analogue Scale (VAS) Score ranges from 0 (no pain) to 10 (most severe pain)

次要结局

  • Change from baseline Quality of Life(14 weeks)
  • Change from baseline Health Status(14 weeks)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Dr. Antonio I Cuesta-Vargas

Professor

University of Malaga

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