Clinical trial NCT01458691: 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
Overall status: COMPLETED
Phase: NA
Conditions: Adhesive Capsulitis
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2011-10-25
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

1. Male or female 18 years of age and older
2. Patients who have had pain at least for 12 months
3. 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:

1. Patients with concurrent bilateral shoulder pain
2. Patients with Diabetes mellitus
3. Patient with overt hypothyroidism or hyperthyroidism
4. Patients who received any drug by intra-articular injection for treatment within 6 months prior to this enrollment.
5. Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
6. Patients with neurological deficit
7. Patients who have a History of allergic adverse reactions to corticosteroid
8. Patients with secondary adhesive capsulitis
9. Patients with systemic inflammatory disease including rheumatoid arthritis
10. Patients with degenerative arthritis, infectious arthritis of shoulder joint
11. Patients who have a history of shoulder trauma including dislocation, fracture
12. Patients taking anticoagulants
13. Patients who have a full-thickness rotator cuff tear
14. Patients who are difficulty participating in data collection due to communication problem and serious mental illness
15. Pregnant women or lactating mothers
16. Patients with cerebrovascular accident
17. Patients with symptomatic cervical spine disorders
18. Patients with serious condition which can affect this study such as severe cardiovascular diseases- renal diseases- liver diseases- endocrine diseases- and cancers

Primary outcomes:
measure: SPADI(Shoulder Pain and Disability Index)Score
timeFrame: Postinjection 1month
measure: Safety determined with symptoms & signs of infection and immune response and adverse events evaluated with NCI-CTCAE v3.0
timeFrame: Postinjection 1month
Secondary outcomes:
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Study officials:
affiliation: Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
name: Chris H. Jo, M.D., Ph.D
role: PRINCIPAL_INVESTIGATOR
References: