The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments (DOFIS)
This study is enrolling participants by invitation only.
Sponsor:
University Rovira i Virgili
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: December 12, 2012
Last verified: December 2012
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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 ]
| Estimated Enrollment: | 99 |
| Study Start Date: | January 2012 |
| Estimated Study Completion Date: | March 2013 |
| Estimated Primary Completion Date: | December 2012 (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
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: | December 12, 2012 |
| 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 May 16, 2013