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Intra-articular Injection of Allogeneic Platelet Rich Plasma (PRP) for Adhesive Capsulitis

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01458691
First Posted: October 25, 2011
Last Update Posted: May 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hyunchul Jo, Seoul National University Hospital
  Purpose
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.

Condition Intervention
Adhesive Capsulitis Procedure: Steroid injection into the glenohumeral joint Procedure: Allogeneic PRP injection into the glenohumeral joint

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis

Further study details as provided by Hyunchul Jo, Seoul National University Hospital:

Primary Outcome Measures:
  • 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.


Enrollment: 58
Study Start Date: September 2013
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Steroid group
Triamcinolone injection group
Procedure: 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.
Experimental: PRP group
Allogeneic PRP injection group
Procedure: 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.

  Eligibility

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • clinical diagnosis : Adhesive Capsulitis of the Shoulder
  • defining of adhesive capsulitis

    • the presence of shoulder pain
    • 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
  • duration : symptomatic for < 1 year

Exclusion Criteria:

  • bilateral symptoms
  • diabetes mellitus
  • overt hypothyroidism or hyperthyroidism
  • previous shoulder surgery
  • previous glenohumeral joint injection within recent 6months
  • trauma to the shoulder the last six months that required hospital care
  • neurological symptoms
  • allergy to injection material
  • secondary adhesive capsulitis
  • systemic inflammatory ds including rheumatoid arthritis
  • degenerative arthritis of shoulder joint
  • infectious arthritis of shoulder joint
  • dislocation of shoulder joint
  • blood coagulation disease
  • rotator cuff tear
  • serious mental illness
  • pregnancy
  • fracture in shoulder lesion
  • CVA
  • 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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01458691


Locations
Korea, Republic of
Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
Seoul, Korea, Republic of
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Chris H. Jo, M.D., Ph.D Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine
  More Information

Responsible Party: Hyunchul Jo, Associate Professor, SMG-SNU Boramae Medical Center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01458691     History of Changes
Other Study ID Numbers: BRM-11-02
First Submitted: October 21, 2011
First Posted: October 25, 2011
Last Update Posted: May 25, 2015
Last Verified: May 2015

Additional relevant MeSH terms:
Periarthritis
Rheumatic Diseases
Bursitis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Connective Tissue Diseases