Shoulder PainPhase 2DOFISNCT01748188
The Effectiveness of Dexketoprofen on Shoulder Pain Using Different Physiotherapy Treatments
A Phase 2 study testing Ultrasound, Phonophoresis and Iontophoresis in people with Shoulder Pain, run by University Rovira i Virgili at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 36 to 70 years
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Ultrasound, Phonophoresis and Iontophoresis
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 99 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2012to May 2014
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 36 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With 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.
Read the 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.
- Conditions
- Shoulder Pain
- Being tested
- Ultrasound, Phonophoresis, Iontophoresis, Exercises, Cryotherapy
- Keywords
- Subacromial syndrome, Dexketoprofen, Phonophoresis, Iontophoresis, Ultrasounds, VAS, DASH score, Constant score
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UltrasoundProcedure or surgery
Ultrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
PhonophoresisProcedure or surgery
Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions.
IontophoresisProcedure or surgery
Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions.
ExercisesProcedure or surgery
Guideline of 7 standardized exercises to improve the muscular force and to open the subacromial space.
CryotherapyProcedure or surgery
Cooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound + Exercises + Cryotherapy | Active comparator | Ultrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions. Receives: Procedure: Ultrasound; Procedure: Exercises; Procedure: Cryotherapy |
| Phonophoresis + Exercises + Cryotherapy | Experimental | Phonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions. Receives: Procedure: Phonophoresis; Procedure: Exercises; Procedure: Cryotherapy |
| Iontophoresis + Exercices + Cryotherapy | Experimental | Iontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions. Receives: Procedure: Iontophoresis; Procedure: Exercises; Procedure: Cryotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain measure by the visual analogic scale pain score.
Measured: 1 month
Secondary outcomes (1)
Functionality of the joint by Dash and Constant scores
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Dec 2012 (estimated)
- Study startJan 2012
- Primary completionApr 2014
- Study completionMay 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Shoulder PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 99 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Rovira i Virgili
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus
- Responsible party
- Principal investigator, Rosa Sola, University Rovira i Virgili
- Investigators
- Carme Casajuana, PT, Study director, Hospital Universitari Sant Joan de Reus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01748188
- Sponsor's protocol ID
- URV
- Acronym
- DOFIS
- Status last verified
- May 2014
- First submitted
- 28 Oct 2012
- Last updated
- 28 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26051846
Study at a glance
From the registry record, last updated by the sponsor on 28 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Valuation of the Dexketoprofen Effectiveness on Subacromial Syndrome With Different Physiotherapy Treatments.
- ClinicalTrials.gov ID
- NCT01748188
- Acronym / sponsor ID
- DOFIS / URV
- Conditions
- Shoulder Pain
- Keywords
- Subacromial syndrome, Dexketoprofen, Phonophoresis, Iontophoresis, Ultrasounds, VAS, DASH score, Constant score
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 99 participants (actual)
- Lead sponsor
- University Rovira i VirgiliUniversity, hospital or other
- Collaborators
- Hospital Universitari Sant Joan de Reus
- Study start
- Jan 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- May 2014 (actual)
- First posted
- 12 Dec 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ultrasound + Exercises + Cryotherapy | Active comparator | Procedure: Ultrasound, Procedure: Exercises, Procedure: CryotherapyUltrasound of 1 Megahertz (MHz), intensity 2 W/cm2, 5 minutes, for 20 sessions. |
| Phonophoresis + Exercises + Cryotherapy | Experimental | Procedure: Phonophoresis, Procedure: Exercises, Procedure: CryotherapyPhonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions. |
| Iontophoresis + Exercices + Cryotherapy | Experimental | Procedure: Iontophoresis, Procedure: Exercises, Procedure: CryotherapyIontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 milliamperes (mA), 20 minutes, for 20 sessions. |
Who may qualify
- Ages
- 36 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (7 listed)
- To suffer shoulder arthritis or any shoulder pathology with mobility limitation.
- Fibromyalgia
- Psychologic or psychiatric pathologies
- Hypersensibility to the drug
- Back or shoulder traumatism
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UltrasoundUltrasound of 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions. | Procedure or surgery | Ultrasound + Exercises + Cryotherapy |
| PhonophoresisPhonophoresis with 50 mg dexketoprofen (Enangel), 1 MHz, intensity 2 W/cm2, 5 minutes, for 20 sessions. | Procedure or surgery | Phonophoresis + Exercises + Cryotherapy |
| IontophoresisIontophoresis by galvanic direct current with 50 mg dexketoprofen (Enantyum), intensity 2 mA, 20 minutes, for 20 sessions. | Procedure or surgery | Iontophoresis + Exercices + Cryotherapy |
| ExercisesGuideline of 7 standardized exercises to improve the muscular force and to open the subacromial space. | Procedure or surgery | Iontophoresis + Exercices + Cryotherapy, Phonophoresis + Exercises + Cryotherapy, Ultrasound + Exercises + Cryotherapy |
| CryotherapyCooling located by a cold air bundle to -32 Celsius degrees (ºC) for 3 minutes. | Procedure or surgery | Iontophoresis + Exercices + Cryotherapy, Phonophoresis + Exercises + Cryotherapy, Ultrasound + Exercises + Cryotherapy |
Primary outcome
Pain measure by the visual analogic scale pain score.
Time frame: 1 month
1 secondary outcome
Functionality of the joint by Dash and Constant scores
Time frame: 1 month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2014.
- Derived from this study: PubMed 26051846Perez-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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carme Casajuana, PT study director
Hospital Universitari Sant Joan de Reus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ultrasound, Phonophoresis and Iontophoresis in people with Shoulder Pain, run by University Rovira i Virgili at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain measure by the visual analogic scale pain score. (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01748188, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 May 2014.