Subacromial Impingement SyndromePhase 2/3NCT01735058
Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in Rotator Cuff Disease
A Phase 2/3 study testing Sodium Hyaluronate and Normal saline in people with Subacromial Impingement Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
Trial summary
This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Sodium Hyaluronate and Normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 48 participants
- Where
- 1 siteIran
- Study dates
- Feb 2012to Dec 2012
- Phase
- Phase 2/3
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age >= 18 years
- subacromial impingement syndrome
- without a complete tear of rotator cuff
- willingness to participate
Who cannot join
- had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors.
- had hypersensitivity to hyaluronate
- had participated in any other study within 6 months
- had received a subacromial injection within 8 weeks
- were pregnant or planned to become pregnant
- were at risk of complications of intra-articular injections such as patients who received anti-coagulant drugs.
Trial locations and contacts
1 site in 1 country.
Farnaz Dehghan, MD contact
Iran1 site, 1 recruiting
- Recruiting
Department of Rehabilitation, Alzahra Hospital
Isfahan, Isfahan
Alireza Moghtaderi, MD, moghtaderia@yahoo.com
Alireza Moghtaderi, MD
About this study
Official title: Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease
This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
Read the detailed description
Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Sodium Hyaluronate, Normal saline
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sodium HyaluronateDrug
Ultrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections.
Normal salineDrug
Ultrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections.
| Study group | Role | What they receive |
|---|---|---|
| Sodium hyaluronate | Active comparator | Ultrasound guided injection of sodium hyaluronate Receives: Drug: Sodium Hyaluronate |
| Normal saline | Placebo comparator | Ultrasound guided injection of normal saline Receives: Drug: Normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in pain severity after 3 weeks.
The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.
Measured: Up to 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startFeb 2012
- Primary completionDec 2012 (estimated)
- Study completionDec 2012 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Isfahan University of Medical Sciences
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Farnaz Dehgan Hosseinabadi, Isfahan University of Medical Sciences
- Investigators
- Farnaz Dehghan, MD, Principal investigator, Isfahan University of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735058
- Sponsor's protocol ID
- 13912134
- Status last verified
- Dec 2012
- First submitted
- 16 Nov 2012
- Last updated
- 4 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.
PubMed 15756189Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.
PubMed 18096343Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.
PubMed 22366365Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.
PubMed 19963403
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Efficacy of Ultrasonography Guided Subacromial Sodium Hyaluronate Injection in the Treatment of Rotator Cuff Disease
- ClinicalTrials.gov ID
- NCT01735058
- Acronym / sponsor ID
- 13912134
- Conditions
- Subacromial Impingement Syndrome
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Isfahan University of Medical SciencesUniversity, hospital or other
- Study start
- Feb 2012
- Primary completion
- Dec 2012 (estimated)
- Study completion
- Dec 2012 (estimated)
- First posted
- 28 Nov 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.
This study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
Detailed description
Rotator cuff disease in particular is a common cause of shoulder pain and weakness and comprises a significant proportion of the musculoskeletal complaints presenting to primary care doctors. Ultrasound is a readily available and cheap modality for looking more specifically at the rotator cuff and surrounding structures. More recently, ultrasound guidance has become a commonly employed method to perform diagnostic or therapeutic interventions. Despite the long history and the fact that this is a common diagnosis made in clinical practice, the exact cause and best treatment for this condition still are being explored. Although there are a few high-quality studies demonstrating the efficacy of sodium hyaluronate injection for rotator cuff disease, this study will be performed to examine the effect of ultrasound-guided subacromial sodium hyaluronate injection in patients with impingement syndrome without rotator cuff complete tear.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sodium hyaluronate | Active comparator | Drug: Sodium HyaluronateUltrasound guided injection of sodium hyaluronate |
| Normal saline | Placebo comparator | Drug: Normal salineUltrasound guided injection of normal saline |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age >= 18 years
- subacromial impingement syndrome
- without a complete tear of rotator cuff
- willingness to participate
Key exclusion criteria (6 listed)
- had any rheumatic disease, glenohumeral osteoarthritis, full-thickness rotator cuff tears, fractures, diabetes mellitus, infections, or tumors.
- had hypersensitivity to hyaluronate
- had participated in any other study within 6 months
- had received a subacromial injection within 8 weeks
- were pregnant or planned to become pregnant
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 |
|---|---|---|
| Sodium HyaluronateUltrasound guided injection of sodium hyaluronate; Fermathron ™, 20 mg/2ml of Sodium Hyaluronate, 3 weekly injections. | Drug | Sodium hyaluronate |
| Normal salineUltrasound guided injection of 0.9% normal sodium hyaluronate line solution, at 2 mL/syringe, 3 weekly injections. | Drug | Normal saline |
Primary outcome
Change from baseline in pain severity after 3 weeks.
Time frame: Up to 3 weeks
The pain score (100 mm Visual Analogue Score ) is evaluated before the first injection and one week after each injection up to 3rd week.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Dec 2012.
- Background: PubMed 15756189Andrews JR. Diagnosis and treatment of chronic painful shoulder: review of nonsurgical interventions. Arthroscopy. 2005 Mar;21(3):333-47. doi: 10.1016/j.arthro.2004.11.003.
- Background: PubMed 18096343Meloni F, Milia F, Cavazzuti M, Doria C, Lisai P, Profili S, Meloni GB. Clinical evaluation of sodium hyaluronate in the treatment of patients with sopraspinatus tendinosis under echographic guide: experimental study of periarticular injections. Eur J Radiol. 2008 Oct;68(1):170-3. doi: 10.1016/j.ejrad.2007.11.001. Epub 2007 Dec 21.
- Background: PubMed 22366365Kim YS, Park JY, Lee CS, Lee SJ. Does hyaluronate injection work in shoulder disease in early stage? A multicenter, randomized, single blind and open comparative clinical study. J Shoulder Elbow Surg. 2012 Jun;21(6):722-7. doi: 10.1016/j.jse.2011.11.009. Epub 2012 Feb 25.
- Background: PubMed 19963403Chou WY, Ko JY, Wang FS, Huang CC, Wong T, Wang CJ, Chang HE. Effect of sodium hyaluronate treatment on rotator cuff lesions without complete tears: a randomized, double-blind, placebo-controlled study. J Shoulder Elbow Surg. 2010 Jun;19(4):557-63. doi: 10.1016/j.jse.2009.08.006. Epub 2009 Dec 5.
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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.
Farnaz Dehghan, MD contact
Farnaz Dehghan, MD principal investigator
Isfahan University of Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Sodium Hyaluronate and Normal saline in people with Subacromial Impingement Syndrome, run by Isfahan University of Medical Sciences at 1 site in Iran.
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 4 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 4 Dec 2012. 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 Iran. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Farnaz Dehghan, MD (dr.farnaz.dehghan@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in pain severity after 3 weeks. (time frame: Up to 3 weeks). 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 NCT01735058, which also lists 4 linked publications.
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 4 Dec 2012.