Therapeutic Progressive Exercise on Shoulder Impingement Syndrome

Study Overview
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Brief Summary
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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.

Detailed Description
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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. Regarding the progression criteria, there seems to be a tendency to consider the modulation of the painful sensation as the main benchmark from which the exercise may progress in difficulty, but some other progression sub-criteria can also be found, such as fatigue or subjective perception. Furthermore, the presence of other conditioning elements, like proximity to pain threshold or a certain reference value in the Visual Analogue Scale (VAS), reduces the homogeneity among the exercise programs and hinders the standardization of the ideal exercise progression when performing the exercises for the management of SIS. The main objective of this clinical trial is to prove the efficacy of a progressive exercise program based on strength and resistance training in comparison to an exercise protocol from the literature to increase neuromuscular and cardiorespiratory capacities and improve the symptoms in subjects with SIS. In addition, we propose to determine the existence or not of statistically significant differences between treatment modalities by evaluating whether these changes occur before, during or after the application of the proposed exercise protocol.

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

Conditions
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Shoulder Impingement, Tendinopathy

Intervention / Treatment
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* Other: Neuromuscular resistance exercise program
* Other: Control exercise program with elastic band


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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. Cancer.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled trial
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neuromuscular resistance exercise group<br>Subjects will develop an innovator program consisting in the performance of exercises of increasing difficulty, with movements based on functional tests to analyze the subjects' neuromuscular capacities. Participants will attend to 80 individual, face-to-face physiotherapy sessions, including both supervised and semi-supervised monitoring. From the total, a minimum of 15 sessions will be supervised, including 6 sessions to teach and monitor the exercises, and 9 sessions to perform the tests in order to quantify the load; 37 sessions will be semi-supervised, where subjects will perform the exercises independently, but with the presence of an instructor; additionally, the remaining 28 sessions will consist in non-supervised aerobic work at a 70-80% from maximum heart rate, obtained according to the methodology of Tanaka et al. | Other: Neuromuscular resistance exercise program<br>* This neuromuscular resistance exercise program will be organized in 5 stages, distributing the different phases in 2, 4, 4, 2 and 2 weeks respectively, with a frequency of 3 sessions/week. In addition, 2 weekly sessions of aerobic work with cycloergometer will be developed. The duration of each session will last 30 minutes. The parameters of load and execution speed will be modified as the exercise program progresses along the phases, with the goal of have an impact on the different aspects of the neuromuscular system.<br>|
| Active Comparator: Control exercise group<br>This program will be based on a home exercise protocol considering painful sensation and self-perceived stability as progression criteria: regarding pain management, exercises will be planned in a way that increased pain after their performance reverts to before-exercise levels prior to the next session; regarding self-perceived stability, participants will be asked to maintain a constant sensation of joint stability and control during the execution of the exercises. Participants will perform shoulder rotations (external and internal) and abduction up to 30º by using elastic bands. The resistance of the band will be adjusted by the physiotherapist so that participants perceive the exercises as demanding enough but not too unpleasant, being able to complete the 10 repetitions before taking the rest. Likewise, exercises will progress until a maximum of 90º of shoulder abduction. | Other: Control exercise program with elastic band<br>* This program is based on previous literature so that it remains comparable to the experimental program. The parameters will consist in 3 sets of 10 repetitions, 2 times/day, 3 times/week, for a total of 6 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in Function measured with Disability of the Arm, Shoulder and Hand (DASH) | Functional scores from Disability of the Arm, Shoulder and Hand (DASH) questionnaire. Score ranges from 0 (no disability) to 100 (most severe disability) | 14 weeks | 
| Change from baseline in Function measured with Constant-Murley Score (CMS) | 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. | 14 weeks | 
| Change from baseline in Function measured with Upper Limb Functional Index (ULFI) | Functional scores from Upper Limb Functional Index (ULFI) Score ranges from 0 (no disability) to 25 (most severe disability) | 14 weeks | 
| Change from baseline Painful Sensation | Pain scores from Visual Analogue Scale (VAS) Score ranges from 0 (no pain) to 10 (most severe pain) | 14 weeks | 
| Change from baseline Range of motion (ROM) | Active shoulder joint ROM (flexion, extension, abduction, internal/external rotations) by goniometry | 14 weeks | 
| Change from baseline Subacromial Space | Measurement of subacromial space by ultrasonography | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Quality of Life | Quality of life scores from EuroQol-5D questionnaire EQ-5D embodies two components: Health state description: subjects select one of three different levels of problem severity within each of five health domains. The levels are none, moderate and severe/extreme (coded 1 through 3, respectively), whilst the domains are mobility, capacity for self-care, conduct of usual activities, pain/discomfort and anxiety/depression. Evaluation: using a visual analogue scale (VAS), ranging from 0 (worst imaginable health state) and at 100 (best imaginable health state) | 14 weeks | 
| Change from baseline Health Status | Health status scores from Short-Form 12 (SF-12) questionnaire SF-12 gathers information from eight domains: the higher the scores, the better the health) | 14 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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shoulder impingement syndrome, tendinopathy, exercise