Effectiveness of Cervicothoracic Manipulative Treatment in Unilateral Shoulder Impingement Syndrome: A Randomized Controlled Trial.
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|ClinicalTrials.gov Identifier: NCT02214199|
Recruitment Status : Completed
First Posted : August 12, 2014
Last Update Posted : April 21, 2016
|Condition or disease||Intervention/treatment||Phase|
|Shoulder Pain Manual Theapy Exercises Therapy||Other: Manipulative Therapy Techniques Other: Home Exercises||Early Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||92 participants|
|Intervention Model:||Single Group Assignment|
|Study Start Date :||August 2014|
|Actual Primary Completion Date :||May 2015|
|Actual Study Completion Date :||December 2015|
Active Comparator: Exercise Therapy
Home exercises for 30 minutes (2/weeks) with muscle stretching and strengthening the shoulder girdle.
Other: Home Exercises
Experimental: Manipulative Therapy Techniques
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
- Disability Questionnaire Arm, Shoulder and Hand (DASHe) [ Time Frame: At baseline and 5 weeks ]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
- Shoulder Disability Questionnaire [ Time Frame: At baseline and 5 weeks ]Shoulder Disability Questionnaire is a mesure covering 16 items designed to evaluate functional status limitation in patients with shoulder disorders.
- Hawkins-Kennedy Test [ Time Frame: At baseline and 5 weeks ]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.
- Neer Test. [ Time Frame: At baseline and 5 weeks ]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.
- Range of Motion [ Time Frame: At baseline and 5 weeks ]The range of motion will be evaluated in flexion, extension, rotation, adduction, and abduction.
- Visual Analogue Scale [ Time Frame: At baseline and 5 weeks ]A 10-point numerical pain scale (0:no pain, 10: maximum pain) assesses the intensity of pain.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02214199
|Universidad de Almeria|
|Almería, Spain, 04120|