The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments

Shoulder Pain Clinical Trial

— DOFIS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01748188
• Other study ID #: URV
• Status: Completed
• Phase: Phase 2
• First received: October 28, 2012
• Last updated: May 27, 2014
• Start date: January 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University Rovira i Virgili
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Comité Ético de Investigación Clínica
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 99
• Est. completion date: May 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 36 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Shoulder Pain

Intervention

Procedure:
• Ultrasound
Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
• Phonophoresis
Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
• Iontophoresis
Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.
• Exercises
Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.
• Cryotherapy
Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.

Locations

Country	Name	City	State
Spain	Hospital Universitari Sant Joan	Reus	Tarragona

Sponsors (2)

Lead Sponsor	Collaborator
University Rovira i Virgili	Hospital Universitari Sant Joan de Reus

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain measure by the visual analogic scale pain score.		1 month	No
Secondary	Functionality of the joint by Dash and Constant scores		1 month	No