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Completed

NCT Number: NCT01458691

Intra-articular Injection of Allogeneic Platelet Rich Plasma (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.

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Key information

Conditions

Adhesive Capsulitis Bursitis Joint Diseases Musculoskeletal Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Joint & Spine Center, SMG-SNU Boramae Medical Center, Department of Orthopedic Surgery, Seoul National University College of Medicine

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Steroid injection into the glenohumeral joint

Procedure
  • 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 joint

Procedure
  • 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 outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

Intra-articular Injection of Allogeneic PRP for Adhesive Capsulitis

Important dates

Study start
2013
Primary completion
2015
Study completion
2015
First posted
Oct 25, 2011
Registry last updated
Oct 8, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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