NCT01748188

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
99

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Jan 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 28, 2012

Completed
2 months until next milestone

First Posted

Study publicly available on registry

December 12, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2014

Completed
Last Updated

May 28, 2014

Status Verified

May 1, 2014

Enrollment Period

2.2 years

First QC Date

October 28, 2012

Last Update Submit

May 27, 2014

Conditions

Shoulder Pain

Keywords

Subacromial syndromeDexketoprofenPhonophoresisIontophoresisUltrasoundsVASDASH scoreConstant score

Outcome Measures

Primary Outcomes (1)

  • Pain measure by the visual analogic scale pain score.

    1 month

Secondary Outcomes (1)

  • Functionality of the joint by Dash and Constant scores

    1 month

Study Arms (3)

Ultrasound + Exercises + Cryotherapy

ACTIVE COMPARATOR

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

Procedure: UltrasoundProcedure: ExercisesProcedure: Cryotherapy

Phonophoresis + Exercises + Cryotherapy

EXPERIMENTAL

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

Procedure: PhonophoresisProcedure: ExercisesProcedure: Cryotherapy

Iontophoresis + Exercices + Cryotherapy

EXPERIMENTAL

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

Procedure: IontophoresisProcedure: ExercisesProcedure: Cryotherapy

Interventions

UltrasoundPROCEDURE

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

Ultrasound + Exercises + Cryotherapy
PhonophoresisPROCEDURE

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

Phonophoresis + Exercises + Cryotherapy
IontophoresisPROCEDURE

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

Iontophoresis + Exercices + Cryotherapy
ExercisesPROCEDURE

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

Iontophoresis + Exercices + CryotherapyPhonophoresis + Exercises + CryotherapyUltrasound + Exercises + Cryotherapy
CryotherapyPROCEDURE

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

Iontophoresis + Exercices + CryotherapyPhonophoresis + Exercises + CryotherapyUltrasound + Exercises + Cryotherapy

Eligibility Criteria

Age36 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Universitari Sant Joan

Reus, Tarragona, 43204, Spain

Location

Related Publications (1)

  • Perez-Merino L, Casajuana MC, Bernal G, Faba J, Astilleros AE, Gonzalez R, Giralt M, Romeu M, Nogues MR. Evaluation of the effectiveness of three physiotherapeutic treatments for subacromial impingement syndrome: a randomised clinical trial. Physiotherapy. 2016 Mar;102(1):57-63. doi: 10.1016/j.physio.2015.01.010. Epub 2015 Mar 25.

    PMID: 26051846DERIVED

MeSH Terms

Conditions

Shoulder Pain

Interventions

High-Energy Shock WavesPhonophoresisIontophoresisExerciseCryotherapy

Condition Hierarchy (Ancestors)

ArthralgiaJoint DiseasesMusculoskeletal DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ultrasonic WavesSoundRadiation, NonionizingRadiationPhysical PhenomenaDrug Administration RoutesDrug TherapyTherapeuticsElectrophoresisElectrochemical TechniquesInvestigative TechniquesMotor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • Carme Casajuana, PT

    Hospital Universitari Sant Joan de Reus

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
University Professor

Study Record Dates

First Submitted

October 28, 2012

First Posted

December 12, 2012

Study Start

January 1, 2012

Primary Completion

April 1, 2014

Study Completion

May 1, 2014

Last Updated

May 28, 2014

Record last verified: 2014-05

Locations

ES(1)