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

Primary Purpose

Shoulder Pain

Status
Completed
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Ultrasound
Phonophoresis
Iontophoresis
Exercises
Cryotherapy
Sponsored by
University Rovira i Virgili
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Shoulder Pain focused on measuring Subacromial syndrome, Dexketoprofen, Phonophoresis, Iontophoresis, Ultrasounds, VAS, DASH score, Constant score

Eligibility Criteria

36 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hospital Universitari Sant Joan

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Experimental

Arm Label

Ultrasound + Exercises + Cryotherapy

Phonophoresis + Exercises + Cryotherapy

Iontophoresis + Exercices + Cryotherapy

Arm Description

Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions.

Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.

Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions.

Outcomes

Primary Outcome Measures

Pain measure by the visual analogic scale pain score.

Secondary Outcome Measures

Functionality of the joint by Dash and Constant scores

Full Information

First Posted
October 28, 2012
Last Updated
May 27, 2014
Sponsor
University Rovira i Virgili
Collaborators
Hospital Universitari Sant Joan de Reus
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1. Study Identification

Unique Protocol Identification Number
NCT01748188
Brief Title
The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments
Acronym
DOFIS
Official Title
Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With Different Physiotherapy Treatments.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2014
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
May 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University Rovira i Virgili
Collaborators
Hospital Universitari Sant Joan de Reus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shoulder Pain
Keywords
Subacromial syndrome, Dexketoprofen, Phonophoresis, Iontophoresis, Ultrasounds, VAS, DASH score, Constant score

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
99 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound + Exercises + Cryotherapy
Arm Type
Active Comparator
Arm Description
Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions.
Arm Title
Phonophoresis + Exercises + Cryotherapy
Arm Type
Experimental
Arm Description
Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Arm Title
Iontophoresis + Exercices + Cryotherapy
Arm Type
Experimental
Arm Description
Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions.
Intervention Type
Procedure
Intervention Name(s)
Ultrasound
Intervention Description
Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Intervention Type
Procedure
Intervention Name(s)
Phonophoresis
Intervention Description
Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Intervention Type
Procedure
Intervention Name(s)
Iontophoresis
Intervention Description
Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.
Intervention Type
Procedure
Intervention Name(s)
Exercises
Intervention Description
Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.
Intervention Type
Procedure
Intervention Name(s)
Cryotherapy
Intervention Description
Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.
Primary Outcome Measure Information:
Title
Pain measure by the visual analogic scale pain score.
Time Frame
1 month
Secondary Outcome Measure Information:
Title
Functionality of the joint by Dash and Constant scores
Time Frame
1 month

10. Eligibility

Sex
All
Minimum Age & Unit of Time
36 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carme Casajuana, PT
Organizational Affiliation
Hospital Universitari Sant Joan de Reus
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Universitari Sant Joan
City
Reus
State/Province
Tarragona
ZIP/Postal Code
43204
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
26051846
Citation
Perez-Merino L, Casajuana MC, Bernal G, Faba J, Astilleros AE, Gonzalez R, Giralt M, Romeu M, Nogues MR. Evaluation of the effectiveness of three physiotherapeutic treatments for subacromial impingement syndrome: a randomised clinical trial. Physiotherapy. 2016 Mar;102(1):57-63. doi: 10.1016/j.physio.2015.01.010. Epub 2015 Mar 25.
Results Reference
derived

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The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments

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