Back to resultsIntra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis
Primary Purpose
Adhesive Capsulitis
Status
Completed
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Steroid injection into the glenohumeral joint
Allogeneic PRP injection into the glenohumeral joint
Sponsored by
About this trial
This is an interventional treatment trial for Adhesive Capsulitis
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
- 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
Sites / Locations
- Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Steroid group
PRP group
Arm Description
Triamcinolone injection group
Allogeneic PRP injection group
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT01458691
First Posted
October 21, 2011
Last Updated
October 6, 2020
Sponsor
Seoul National University Hospital
1. Study Identification
Unique Protocol Identification Number
NCT01458691
Brief Title
Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis
Official Title
Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis
Study Type
Interventional
2. Study Status
Record Verification Date
May 2015
Overall Recruitment Status
Completed
Study Start Date
September 2013 (undefined)
Primary Completion Date
March 2015 (Actual)
Study Completion Date
October 20, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Seoul National University Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Adhesive Capsulitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
58 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Steroid group
Arm Type
Active Comparator
Arm Description
Triamcinolone injection group
Arm Title
PRP group
Arm Type
Experimental
Arm Description
Allogeneic PRP injection group
Intervention Type
Procedure
Intervention Name(s)
Steroid injection into the glenohumeral joint
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Allogeneic PRP injection into the glenohumeral joint
Intervention Description
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.
Primary Outcome Measure Information:
Title
SPADI(Shoulder Pain and Disability Index)Score
Description
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.
Time Frame
Postinjection 1month
Title
Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
Description
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.
Time Frame
Postinjection 1month
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Chris H. Jo, M.D., Ph.D
Organizational Affiliation
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
City
Seoul
Country
Korea, Republic of
12. IPD Sharing Statement
Learn more about this trial
Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis
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