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

University Rovira i Virgili

Status and phase: Completed; Phase 2

Conditions: Shoulder Pain

Treatments: Procedure: Exercises; Procedure: Iontophoresis; Procedure: Ultrasound; Procedure: Phonophoresis; Procedure: Cryotherapy

Study type: Interventional

Funder types: Other

Identifiers

NCT01748188

URV

Details and patient eligibility

About

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.

Full 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.

Enrollment: 99 patients

Sex: All

Ages: 36 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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99 participants in 3 patient groups

Ultrasound + Exercises + Cryotherapy

Active Comparator group

Description:

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

Treatment:

Procedure: Ultrasound

Procedure: Cryotherapy

Procedure: Exercises

Phonophoresis + Exercises + Cryotherapy

Experimental group

Description:

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

Treatment:

Procedure: Cryotherapy

Procedure: Phonophoresis

Procedure: Exercises

Iontophoresis + Exercices + Cryotherapy

Experimental group

Description:

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

Treatment:

Procedure: Cryotherapy

Procedure: Exercises

Procedure: Iontophoresis