Subacromial ImpingementNCT04833738
Hyaluronic Acid, Corticosteroid and Electrotherapy in Subacromial Impingement Syndrome
A study testing Hyaluronic acid, Corticosteroids Triamcinolone Acetonide and Electrotherapy in people with Subacromial Impingement and Pain, Shoulder, run by Şeyhmus KAPLAN.
Trial summary
Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Subacromial Impingement, Pain, Shoulder
- What is being tested?
- Hyaluronic acid, Corticosteroids Triamcinolone Acetonide and Electrotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 11 Sep 2013to 28 May 2014
- Phase
- Interventional
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- The diagnosis of subacromial impingement syndrome
Who cannot join
- Patients aged <20 or >50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.
About this study
Official title: Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi
Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome.
Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures.
- Conditions
- Subacromial Impingement, Pain, Shoulder
- Being tested
- Hyaluronic acid, Corticosteroids Triamcinolone Acetonide, Electrotherapy
- Medical subject headings
- Shoulder Impingement Syndrome, Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic acidDrug
Corticosteroids Triamcinolone AcetonideDrug
triamcinolone acetonide, 40 mg/ml, single dose
ElectrotherapyOther
electrotherapy
| Study group | Role | What they receive |
|---|---|---|
| Electrotherapy | Active comparator | Not described Receives: Other: Electrotherapy |
| corticosteroid | Active comparator | Not described Receives: Drug: Corticosteroids Triamcinolone Acetonide |
| hyaluronic acid | Active comparator | Not described Receives: Drug: Hyaluronic acid |
What is being measured
The primary outcome is the main question the study is designed to answer.
Visual Analogue Scale
Higher scores represent higher level of shoulder pain.
Measured: 1 min.
range of motion
Higher scores represent lower level of shoulder function.
Measured: 5 min.
Shoulder Disability Questionnaire
Higher scores represent higher level of shoulder pain.
Measured: 15 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2021
- Study start11 Sep 2013
- Primary completion10 Dec 2013
- Study completion28 May 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Subacromial ImpingementStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Şeyhmus KAPLAN
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Şeyhmus KAPLAN, Yuzuncu Yil University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04833738
- Sponsor's protocol ID
- Yuzuncu Yil University
- Status last verified
- Apr 2021
- First submitted
- 2 Apr 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subakromiyal sıkışma Sendromunda Hyaluronik Asit, Kortikosteroid ve Elektroterapi
- ClinicalTrials.gov ID
- NCT04833738
- Acronym / sponsor ID
- Yuzuncu Yil University
- Conditions
- Subacromial Impingement, Pain, Shoulder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Şeyhmus KAPLANUniversity, hospital or other
- Study start
- 11 Sep 2013 (actual)
- Primary completion
- 10 Dec 2013 (actual)
- Study completion
- 28 May 2014 (actual)
- First posted
- 6 Apr 2021 (actual)
- 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.
Background: Electrotherapy, corticosteroid, and hyaluronic acid have been used to treat subacromial impingement syndrome. However, we need to compare treatment options to provide the optimal results. This study aims to compare the effect of hyaluronic acid, corticosteroid, and electrotherapy in subacromial impingement syndrome.
Design: Ninety five patients were randomised into three equal groups according to treatment types. Hyaluronic acid (20 mg/2ml, three times one week apart) or corticosteroid (triamcinolone acetonide, 40 mg/ml, single dose) treatments were applied as subacromial injections. Electrotherapy consisted of 14 sessions TENS (20 min.), hotpack (20 min.) and ultrasound (1.5watt/cm2, 1 MHz, 6 min.). Patients were evaluated before treatment, one and four weeks post end of treatment. Visual Analogue Scale (VAS), range of motion (ROM), and Shoulder Disability Questionnaire (SDQ) were used as outcome measures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Electrotherapy | Active comparator | Other: Electrotherapy |
| corticosteroid | Active comparator | Drug: Corticosteroids Triamcinolone Acetonide |
| hyaluronic acid | Active comparator | Drug: Hyaluronic acid |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- The diagnosis of subacromial impingement syndrome
Key exclusion criteria (1 listed)
- Patients aged <20 or >50 years or who have the following medical conditions were excluded: physical therapy or injection in the past 6 months, shoulder instability, acute trauma, adhesive capsulitis, psychiatric illness, diabetes mellitus, malignancy.
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 |
|---|---|---|
| Hyaluronic acid | Drug | hyaluronic acid |
| Corticosteroids Triamcinolone Acetonidetriamcinolone acetonide, 40 mg/ml, single dose | Drug | corticosteroid |
| Electrotherapyelectrotherapy | Other | Electrotherapy |
Primary outcome
Visual Analogue Scale
Time frame: 1 min.
Higher scores represent higher level of shoulder pain.
range of motion
Time frame: 5 min.
Higher scores represent lower level of shoulder function.
Shoulder Disability Questionnaire
Time frame: 15 min
Higher scores represent higher level of shoulder pain.
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 6 Apr 2021.
- Individual participant dataSharing planned: No
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Natural History of Shoulder Pathology in Manual Wheelchair Users
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic acid, Corticosteroids Triamcinolone Acetonide and Electrotherapy in people with Subacromial Impingement and Pain, Shoulder, run by Şeyhmus KAPLAN.
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 1 inclusion and 1 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 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Visual Analogue Scale (time frame: 1 min.). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Apr 2021.