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OpenTrials
Completed

NCT Number: NCT01748188

The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments

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.

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Key information

Conditions

Shoulder Pain Arthralgia Joint Diseases Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

36 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Hospital Universitari Sant Joan

Reus, Tarragona, 43204, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Procedure

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

Phonophoresis

Procedure

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

Iontophoresis

Procedure

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

Exercises

Procedure

Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.

cryotherapy

Procedure

Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.

Primary outcomes

  1. Pain measure by the visual analogic scale pain score.

    Time frame: 1 month

Secondary outcomes

  1. Functionality of the joint by Dash and Constant scores

    Time frame: 1 month

Sponsors and collaborators

Lead sponsor

University Rovira i Virgili

Other

Collaborators

  • Hospital Universitari Sant Joan de Reus

Registry information

Official study title

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

Acronym: DOFIS

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 12, 2012
Registry last updated
May 28, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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