The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments

Study Overview
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Brief Summary
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The purpose of this study is to determine whether dexketoprofen administered by phonophoresis or iontophoresis is more effective in the treatment of subacromial syndrome that the conventional therapy with ultrasounds.

Detailed Description
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It is a question of valuing the decrease of the pain (by means of the visual analogic scale pain score) and the increase of the functionality of the joint (by means of Dash and Constant scores) of three different treatments from physical therapy to establish the most effective protocol for the treatment of the subacromial syndrome. Determine the best physiotherapy treatment for subacromial syndrome with 20 sessions of different treatments. A group will receive the conventional treatment with ultrasounds without drugs, another group will receive dexketoprofen by phonophoresis and the third group will receive dexketoprofen by iontophoresis.

Official Title
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Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With Different Physiotherapy Treatments.

Conditions
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Shoulder Pain

Intervention / Treatment
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* Procedure: Ultrasound
* Procedure: Phonophoresis
* Procedure: Iontophoresis
* Procedure: Exercises
* Procedure: Cryotherapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subacromial syndrome diagnosed by ultrasound scanning with Rotator cuff tendinitis or partial break of the rotator cuff and / or of the brachial biceps. Informed consent. Exclusion Criteria: To suffer shoulder arthritis or any shoulder pathology with mobility limitation. Fibromyalgia Psychologic or psychiatric pathologies Hypersensibility to the drug Back or shoulder traumatism To have received an analgesic infiltration on the affected shoulder in the last month Lack of adherence to the treatment upper to 15 % of the sessions

Ages Eligible for Study
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Minimum Age: 36 Years
Maximum Age: 70 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ultrasound + Exercises + Cryotherapy<br>Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions. | Procedure: Ultrasound<br>* Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.<br>Procedure: Exercises<br>* Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.<br>Procedure: Cryotherapy<br>* Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.<br>|
| Experimental: Phonophoresis + Exercises + Cryotherapy<br>Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions. | Procedure: Phonophoresis<br>* Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.<br>Procedure: Exercises<br>* Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.<br>Procedure: Cryotherapy<br>* Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.<br>|
| Experimental: Iontophoresis + Exercices + Cryotherapy<br>Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions. | Procedure: Iontophoresis<br>* Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.<br>Procedure: Exercises<br>* Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.<br>Procedure: Cryotherapy<br>* Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain measure by the visual analogic scale pain score. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functionality of the joint by Dash and Constant scores |  | 1 month | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Subacromial syndrome, Dexketoprofen, Phonophoresis, Iontophoresis, Ultrasounds, VAS, DASH score, Constant score