Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.

Study Overview
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Brief Summary
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The objective of this protocol is to compare degree of improvement can be achieved in patients with shoulder pain by treatment with Manipulative Techniques for the cervicothoracic spine versus home exercises.

Detailed Description
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Design: Randomized Clinical Trial. Objective: to determine the effects of manipulative techniques for the ervicothoracic spine versus home exercises on pain, disability, and range of movement in patients with unilateral shoulder inmingement syndrome. Methods and Measures: ninety-two subjects will be randomly assigned to one of two groups. Intervention: For 5-weeks, the groups 1 will undergo tratment comprising manipulative protocol techniques for the cervicothoracic spine (2/week) and the group 2 will develop a home exercise (2/week). Main Outcome Measures: Intensity of pain, disability, and range of motion data will be collected at baseline, and 24hr after the last therapy application. Mixed-model analyses of variance will be used to examine the effects of the treatment on each outcome measure.

Conditions
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Shoulder Pain, Manual Theapy, Exercises Therapy

Intervention / Treatment
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* Other: Manipulative Therapy Techniques
* Other: Home Exercises


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Report of pain or dysfunction with overhead activities Demonstration of pain during active shoulder movements Demonstration of a positive Neer/Hawkins-Kennedy test Recent onset within the last 12 months Report of non-traumatic onset Demonstration of a painful arc of the arm from 60° to 120° of flexion Report of a baseline pain level of ≥2/10 on an 11 point numeric scale Exclusion Criteria: The presence of any red flags A history of frozen shoulder Disorders of the acromioclavicular joint Degenerative arthritis of the glenohumeral joint Known calcifying tendonitis (if identified by radiograph) Shoulder instability Posttraumatic disorders Shoulder surgery and/or elbow, hand, wrist and blatantly misdiagnosed cervical spine disorders

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Exercise Therapy<br>Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle. | Other: Home Exercises<br> <br> |
| Experimental: Manipulative Therapy Techniques<br>Lift Technique for mid-thoracic spine. Mobilization by low cervical spine on the upper lateral thoracic translation. Technical Dog flexion for high thoracic spine (T1-T4). Technical Dog flexion for mid-thoracic spine (T5-T8). Technical Dog flexed to low thoracic spine (T9-T12). Direct drive technology prone to mid-thoracic spine. | Other: Manipulative Therapy Techniques<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disability Questionnaire Arm, Shoulder and Hand (DASHe) | This questionnaire asks about the symptoms as well as your ability to perform certain activities. This questionnaire has 30 items, and the results are clasified in: no difficulty, mild difficulty, moderate dificulty, severe dificulty and unable | At baseline and 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Disability Questionnaire | Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders. | At baseline and 5 weeks | 
| Hawkins-Kennedy Test | The Hawkins and Kennedy test was interpreted as indicative of impingement between the greater tuberosity of the humerus against the coraco- humeral ligament, trapping all those structures which intervene. It has been reported as less reliable than the Neer impingement test. | At baseline and 5 weeks | 
| Neer Test. | Neer's Test assesses for possible rotator cuff impingement. Stabilize the scapula and with the thumb pointing down and passively flex the arm. Pain is a positive test. | At baseline and 5 weeks | 
| Range of Motion | The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction. | At baseline and 5 weeks | 
| Visual Analogue Scale | A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain. | At baseline and 5 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Shoulder Pain, Shoulder Impingement Syndrome, Exercise therapy, Randomized Controlled Trial