Adhesive CapsulitisNCT01458691
Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis
A study testing Steroid injection into the glenohumeral joint and Allogeneic PRP injection into the glenohumeral joint in people with Adhesive Capsulitis, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to compare the efficacy of intra-articular allogenic Platelet Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the shoulder. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Adhesive Capsulitis
- What is being tested?
- Steroid injection into the glenohumeral joint and Allogeneic PRP injection into the glenohumeral joint
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2013to 20 Oct 2015
- 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 had pain at least for 12 months
- limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions (abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder in the scapular plane and in progressive degree of horizontal adduction
Who cannot join
- Patients with concurrent bilateral shoulder pain
- Patients with Diabetes mellitus
- Patient with overt hypothyroidism or hyperthyroidism
- Patients who received any drug by intra-articular injection for treatment within 6 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 with neurological deficit
Show all 18Show fewer
- Patients who have a History of allergic adverse reactions to corticosteroid
- Patients with secondary adhesive capsulitis
- Patients with systemic inflammatory disease including rheumatoid arthritis
- Patients with degenerative arthritis, infectious arthritis of shoulder joint
- Patients who have a history of shoulder trauma including dislocation, fracture
- Patients taking anticoagulants
- Patients who have a full-thickness rotator cuff tear
- Patients who are difficulty participating in data collection due to communication problem and serious mental illness
- Pregnant women or lactating mothers
- Patients with cerebrovascular accident
- Patients with symptomatic cervical spine disorders
- 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
About this study
Official title: Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis
The purpose of this study is to compare the efficacy of intra-articular allogenic Platelet Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the shoulder.
- Conditions
- Adhesive Capsulitis
- Being tested
- Steroid injection into the glenohumeral joint, Allogeneic PRP injection into the glenohumeral joint
- Medical subject headings
- Bursitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Steroid injection into the glenohumeral jointProcedure 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 : glenohumeral joint
- Material : 25-gauze spinal needle
- The intra-articular injections were performed using ultrasonographic guidance.
Allogeneic PRP injection into the glenohumeral jointProcedure or surgery
- Group: Allogeneic PRP
- Total volume of injection drugs: 4ml
- The number of injections : only once during the study period
- Injection site : glenohumeral joint
- Material : 25-gauze spinal needle
- The intra-articular 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 glenohumeral joint |
| PRP group | Experimental | Allogeneic PRP injection group Receives: Procedure: Allogeneic PRP injection into the glenohumeral joint |
What is being measured
The primary outcome is the main question the study is designed to answer.
SPADI(Shoulder Pain and Disability Index)Score
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
Measured: Postinjection 1month
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2011 (estimated)
- Study startSep 2013
- Primary completionMar 2015
- Study completion20 Oct 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adhesive CapsulitisStudies 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
- 58 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
- Investigators
- Chris H. Jo, M.D., Ph.D, Principal investigator, Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01458691
- Sponsor's protocol ID
- BRM-11-02
- Status last verified
- May 2015
- First submitted
- 21 Oct 2011
- Last updated
- 8 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis
- ClinicalTrials.gov ID
- NCT01458691
- Acronym / sponsor ID
- BRM-11-02
- Conditions
- Adhesive Capsulitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Sep 2013
- Primary completion
- Mar 2015 (actual)
- Study completion
- 20 Oct 2015 (actual)
- First posted
- 25 Oct 2011 (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 compare the efficacy of intra-articular allogenic Platelet Rich Plasma injection and steroid injection in the treatment of adhesive capsulitis of the shoulder.
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 glenohumeral jointTriamcinolone injection group |
| PRP group | Experimental | Procedure: Allogeneic PRP injection into the glenohumeral jointAllogeneic 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 (3 listed)
- Male or female 18 years of age and older
- Patients who have had pain at least for 12 months
- limitation of both active and passive movements of the glenohumeral joint of ≥25% in at list 2 directions (abduction,flexion,external rotation,internal rotation), as compared with the contralateral shoulder in the scapular plane and in progressive degree of horizontal adduction
Key exclusion criteria (18 listed)
- Patients with concurrent bilateral shoulder pain
- Patients with Diabetes mellitus
- Patient with overt hypothyroidism or hyperthyroidism
- Patients who received any drug by intra-articular injection for treatment within 6 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
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 glenohumeral joint* 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 : glenohumeral joint * Material : 25-gauze spinal needle * The intra-articular injections were performed using ultrasonographic guidance. | Procedure or surgery | Steroid group |
| Allogeneic PRP injection into the glenohumeral joint* Group: Allogeneic PRP * Total volume of injection drugs: 4ml * The number of injections : only once during the study period * Injection site : glenohumeral joint * Material : 25-gauze spinal needle * The intra-articular injections were performed using ultrasonographic guidance. | Procedure or surgery | PRP group |
Primary outcome
SPADI(Shoulder Pain and Disability Index)Score
Time frame: Postinjection 1month
The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use.
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.
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 8 Oct 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.
Chris H. Jo, M.D., Ph.D principal investigator
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
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 glenohumeral joint and Allogeneic PRP injection into the glenohumeral joint in people with Adhesive Capsulitis, 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 3 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 8 Oct 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?
SPADI(Shoulder Pain and Disability Index)Score (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 8 Oct 2020.