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The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments (DOFIS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01748188
Recruitment Status : Completed
First Posted : December 12, 2012
Last Update Posted : May 28, 2014
Sponsor:
Collaborator:
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
Rosa Sola, University Rovira i Virgili

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Shoulder Pain Procedure: Ultrasound Procedure: Phonophoresis Procedure: Iontophoresis Procedure: Exercises Procedure: Cryotherapy Phase 2

Detailed Description:

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With Different Physiotherapy Treatments.
Study Start Date : January 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : May 2014

Arm Intervention/treatment
Active Comparator: Ultrasound + Exercises + Cryotherapy
Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions.
Procedure: Ultrasound
Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.

Procedure: Exercises
Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.

Procedure: Cryotherapy
Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.

Experimental: Phonophoresis + Exercises + Cryotherapy
Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Procedure: Phonophoresis
Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.

Procedure: Exercises
Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.

Procedure: Cryotherapy
Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.

Experimental: Iontophoresis + Exercices + Cryotherapy
Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions.
Procedure: Iontophoresis
Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.

Procedure: Exercises
Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.

Procedure: Cryotherapy
Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.




Primary Outcome Measures :
  1. Pain measure by the visual analogic scale pain score. [ Time Frame: 1 month ]

Secondary Outcome Measures :
  1. Functionality of the joint by Dash and Constant scores [ Time Frame: 1 month ]


Information from the National Library of Medicine

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Ages Eligible for Study:   36 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

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): NCT01748188


Locations
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Spain
Hospital Universitari Sant Joan
Reus, Tarragona, Spain, 43204
Sponsors and Collaborators
University Rovira i Virgili
Hospital Universitari Sant Joan de Reus
Investigators
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Study Director: Carme Casajuana, PT Hospital Universitari Sant Joan de Reus

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Rosa Sola, University Professor, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT01748188    
Other Study ID Numbers: URV
First Posted: December 12, 2012    Key Record Dates
Last Update Posted: May 28, 2014
Last Verified: May 2014
Keywords provided by Rosa Sola, University Rovira i Virgili:
Subacromial syndrome
Dexketoprofen
Phonophoresis
Iontophoresis
Ultrasounds
VAS
DASH score
Constant score
Additional relevant MeSH terms:
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Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Neurologic Manifestations
Signs and Symptoms
Dexketoprofen trometamol
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents