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

This study has been completed.
Sponsor:
Collaborator:
Hospital Universitari Sant Joan de Reus
Information provided by (Responsible Party):
Rosa Sola, University Rovira i Virgili
ClinicalTrials.gov Identifier:
NCT01748188
First received: October 28, 2012
Last updated: May 27, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Shoulder Pain
Procedure: Ultrasound
Procedure: Phonophoresis
Procedure: Iontophoresis
Procedure: Exercises
Procedure: Cryotherapy
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With Different Physiotherapy Treatments.

Resource links provided by NLM:


Further study details as provided by University Rovira i Virgili:

Primary Outcome Measures:
  • Pain measure by the visual analogic scale pain score. [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Functionality of the joint by Dash and Constant scores [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 99
Study Start Date: January 2012
Study Completion Date: May 2014
Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   36 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01748188

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

No publications provided

Responsible Party: Rosa Sola, University Professor, University Rovira i Virgili
ClinicalTrials.gov Identifier: NCT01748188     History of Changes
Other Study ID Numbers: URV
Study First Received: October 28, 2012
Last Updated: May 27, 2014
Health Authority: Spain: Comité Ético de Investigación Clínica

Keywords provided by University Rovira i Virgili:
Subacromial syndrome
Dexketoprofen
Phonophoresis
Iontophoresis
Ultrasounds
VAS
DASH score
Constant score

Additional relevant MeSH terms:
Shoulder Pain
Arthralgia
Joint Diseases
Musculoskeletal Diseases
Pain
Signs and Symptoms

ClinicalTrials.gov processed this record on October 16, 2014