Shoulder Impingement SyndromeNCT02019537
Subacromial Injection of Allogeneic Platelet Rich Plasma (PRP) for Shoulder Impingement Syndrome
A study testing Steroid injection into the subacromial space and Allogeneic PRP injection into the subacromial space in people with Shoulder Impingement Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with subacromial impingement disease Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder Impingement Syndrome
- What is being tested?
- Steroid injection into the subacromial space and Allogeneic PRP injection into the subacromial space
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Feb 2014to Jul 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or female 18 years of age and older
- Patients who have unilateral shoulder pain.
- Patients who have had pain at least for 3 months
- To be included in the study- participants are required to have a \& b.(mentioned below)
- Pain with one of the two tests
- Neer's sign: passive overpressure at full shoulder flexion with the scapula fixed
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- Hawkins test: passive internal rotation at 90 degree of shoulder flexion in the scapular plane and in progressive degree of horizontal adduction
- Pain with one of the two tests
- Painful arc: active shoulder abduction
- Jobe's test: The examiner passively elevates the patient's shoulder to 90 degrees of abduction with internal rotation. The examiner then applies a downward pressure against the arm
Who cannot join
- Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
- Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
- Patients who have a isolated acromioclavicular joint pathology
- Patients who have a full-thickness rotator cuff tear (evidenced by MR or ultrasonography)
- Patients with symptomatic cervical spine disorders
- Patients who have a History of allergic adverse reactions to corticosteroid
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- Patients are unable to give informed consent to participate in the study
- Patients are unable to come into the clinic for regular follow-up
- Patients with adhesive capsulitis- acromioclavicular arthropathy- polyarthritis- infectious arthritis- rheumatoid arthritis or diagnosed fibromyalgia
- Patients with concurrent bilateral shoulder pain
- Patients with neurological deficit
- Patients who have severely abnormal radiological findings including malignancy, severe osteoarthritis of the glenohumeral joint, severe skeletal abnormalities decreasing the subacromial space and etc.
- Presence of shoulder pain with limitation of both active and passive movements of the glenohumeral joint of 25% in at least 2 directions (abduction, flexion, external rotation, internal rotation), as compared with the contralateral shoulder or with normal values
- Patients with Diabetes mellitus
- Patients taking anticoagulants
- Pregnant women or lactating mothers
- Patients who are difficulty participating in data collection due to communication problem and serious mental illness
- Patients with serious condition which can affect this study such as severe cardiovascular diseases- renal diseases- liver diseases- endocrine diseases- and cancers
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, 156-707
About this study
Official title: Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial
The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with subacromial impingement disease
- Conditions
- Shoulder Impingement Syndrome
- Being tested
- Steroid injection into the subacromial space, Allogeneic PRP injection into the subacromial space
- 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.
Steroid injection into the subacromial spaceProcedure or surgery
- Group: Steroid
- Total volume of injection drugs: 4ml(1ml of triamcinolone acetonide 40mg/ml + 3ml of 2% lidocaine)
- The number of injections : only once during the study period
- Injection site : subacromial space
- Material : 25-gauze spinal needle
- Subacromial injections were performed using ultrasonographic guidance.
Allogeneic PRP injection into the subacromial spaceProcedure or surgery
- Group: Allogeneic PRP
- Total volume of injection drugs: 4ml
- The number of injections : only once during the study period
- Injection site : subacromial space
- Material : 25-gauze spinal needle
- Subacromial injections were performed using ultrasonographic guidance.
| Study group | Role | What they receive |
|---|---|---|
| Steroid group | Active comparator | Triamcinolone injection group Receives: Procedure: Steroid injection into the subacromial space |
| PRP group | Experimental | Allogeneic PRP injection group Receives: Procedure: Allogeneic PRP injection into the subacromial space |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
Presence of general symptoms or signs associated with infection and immune response, such as rash, pruritus, fever, chills, urticaria, or dyspnea.
Injection sites were examined to identify erythema, swelling, or abnormal discharge.
Adverse events were categorised with use of the National Cancer Institute Common Terminology Criteria for Adverse Events scale, version 3.0.
Measured: Postinjection 1month
Constant-Murley score
The Constant-Murley score (CMS) is a 100-points scale composed of parameters defining the level of pain and the ability of performing daily activities.
Measured: Postinjection 1month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2013 (estimated)
- Study startFeb 2014
- Primary completionJun 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Shoulder Impingement SyndromeStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- 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
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyunchul Jo, Seoul National University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02019537
- Sponsor's protocol ID
- BRM-13-01
- Status last verified
- Sep 2020
- First submitted
- 18 Dec 2013
- Last updated
- 18 Sep 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Allogeneic Platelet-Rich Plasma Versus Corticosteroid Injection for the Treatment of Rotator Cuff Disease: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT02019537
- Acronym / sponsor ID
- BRM-13-01
- Conditions
- Shoulder Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Feb 2014
- Primary completion
- Jun 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 24 Dec 2013 (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 investigate the efficacy of allogeneic PRP in patients with subacromial impingement disease
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Steroid group | Active comparator | Procedure: Steroid injection into the subacromial spaceTriamcinolone injection group |
| PRP group | Experimental | Procedure: Allogeneic PRP injection into the subacromial spaceAllogeneic PRP injection group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female 18 years of age and older
- Patients who have unilateral shoulder pain.
- Patients who have had pain at least for 3 months
- To be included in the study- participants are required to have a \& b.(mentioned below)
Key exclusion criteria (18 listed)
- Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
- Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
- Patients who have a isolated acromioclavicular joint pathology
- Patients who have a full-thickness rotator cuff tear (evidenced by MR or ultrasonography)
- Patients with symptomatic cervical spine disorders
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 |
|---|---|---|
| Steroid injection into the subacromial space* Group: Steroid * Total volume of injection drugs: 4ml(1ml of triamcinolone acetonide 40mg/ml + 3ml of 2% lidocaine) * The number of injections : only once during the study period * Injection site : subacromial space * Material : 25-gauze spinal needle * Subacromial injections were performed using ultrasonographic guidance. | Procedure or surgery | Steroid group |
| Allogeneic PRP injection into the subacromial space* Group: Allogeneic PRP * Total volume of injection drugs: 4ml * The number of injections : only once during the study period * Injection site : subacromial space * Material : 25-gauze spinal needle * Subacromial injections were performed using ultrasonographic guidance. | Procedure or surgery | PRP group |
Primary outcome
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
Time frame: Postinjection 1month
Presence of general symptoms or signs associated with infection and immune response, such as rash, pruritus, fever, chills, urticaria, or dyspnea. Injection sites were examined to identify erythema, swelling, or abnormal discharge. Adverse events were categorised with use of the National Cancer Institute Common Terminology Criteria for Adverse Events scale, version 3.0.
Constant-Murley score
Time frame: Postinjection 1month
The Constant-Murley score (CMS) is a 100-points scale composed of parameters defining the level of pain and the ability of performing daily activities.
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 18 Sep 2020.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Steroid injection into the subacromial space and Allogeneic PRP injection into the subacromial space in people with Shoulder Impingement Syndrome, run by Seoul National University Hospital at 1 site in South Korea.
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 10 inclusion and 18 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 18 Sep 2020. 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 South Korea. 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.
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?
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0 (time frame: Postinjection 1month). The study lists 2 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 18 Sep 2020.