The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments

Phase 2

Completed

• Conditions: Shoulder Pain
• Interventions: Procedure: Ultrasound; Procedure: Phonophoresis; Procedure: Iontophoresis; Procedure: Exercises; Procedure: Cryotherapy

• Registration Number: NCT01748188
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2012-01
• Study First Submitted: 2012-10-28
• Study First Submitted QC: 2012-12-10
• Study First Posted: 2012-12-12
• Primary Completion: 2014-04
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-27
• Last Update Posted: 2014-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 99

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ultrasound + Exercises + Cryotherapy	Ultrasound	Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions.
Ultrasound + Exercises + Cryotherapy	Exercises	Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions.
Ultrasound + Exercises + Cryotherapy	Cryotherapy	Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions.
Phonophoresis + Exercises + Cryotherapy	Phonophoresis	Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Phonophoresis + Exercises + Cryotherapy	Exercises	Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Phonophoresis + Exercises + Cryotherapy	Cryotherapy	Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
Iontophoresis + Exercices + Cryotherapy	Iontophoresis	Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions.
Iontophoresis + Exercices + Cryotherapy	Exercises	Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions.
Iontophoresis + Exercices + Cryotherapy	Cryotherapy	Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions.

Primary Outcome Measures

Name	Time	Method
Pain measure by the visual analogic scale pain score.	1 month

Secondary Outcome Measures

Name	Time	Method
Functionality of the joint by Dash and Constant scores	1 month

Trial Locations

Locations (1)

Hospital Universitari Sant Joan; 🇪🇸 Reus, Tarragona, Spain