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Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder

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ClinicalTrials.gov Identifier: NCT03013205
Recruitment Status : Unknown
Verified January 2017 by National Taiwan University Hospital.
Recruitment status was:  Not yet recruiting
First Posted : January 6, 2017
Last Update Posted : January 6, 2017
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Brief Summary:
Steroid injections are widely utilized to reduce inflammation and fibrosis in patients with the frozen shoulder. In this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

Condition or disease Intervention/treatment Phase
Direct Coracohumeral Ligament Steroid Injection Procedure: Intraarticular triamcinolone injection Procedure: Intraarticular Xylocaine injection Procedure: Coracohumeral ligament triamcinolone injection Procedure: Physiotherapy Not Applicable

Detailed Description:

Adhesive capsulitis of the shoulder, also known as the frozen shoulder, often leads to severe pain and shoulder range of motion limitation. Steroid injections are widely utilized to reduce inflammation and fibrosis. The thickening of the coracohumeral ligament was thought to play an important role in the pathogenesis of frozen shoulder, resulting in limited external rotation of the shoulder. While the elastogram of coracohumeral ligament will significantly increase stiffness under the shear-wave ultrasound (shear-wave elastography).

Therefore, in this study, investigators will compare intra-articular steroid injections with direct coracohumeral ligament steroid injection to conventional intra-articular steroid injection. Investigators will measure the primary outcome as shoulder function improvement and secondary outcomes as ROM, pain scale and stiffness of coracohumeral ligament under elastogram.

(the patient will not have additional risk of injection under ultrasound guidance)


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Efficacy of Corticosteroid Injection Into Coracohumeral Ligament in Patients With Adhesive Capsulitis of the Shoulder
Study Start Date : February 2017
Estimated Primary Completion Date : October 2018
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: PT+IA+CHL
  1. Intraarticular triamcinolone injection
  2. Intraarticular Xylocaine injection
  3. Coracohumeral ligament triamcinolone injection
  4. Physiotherapy
Procedure: Intraarticular triamcinolone injection
triamcinolone 10mg/mL

Procedure: Intraarticular Xylocaine injection
Xylocaine 1% 4ml

Procedure: Coracohumeral ligament triamcinolone injection
triamcinolone 10mg/mL

Procedure: Physiotherapy
Active Comparator: PT+IA
  1. Intraarticular triamcinolone injection
  2. Intraarticular Xylocaine injection
  3. Physiotherapy
Procedure: Intraarticular triamcinolone injection
triamcinolone 10mg/mL

Procedure: Intraarticular Xylocaine injection
Xylocaine 1% 4ml

Procedure: Physiotherapy



Primary Outcome Measures :
  1. Shoulder function (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash) improvement [ Time Frame: 2 years ]
    shoulder function improvement (The Disabilities of the Arm, Shoulder and Hand Score, QuickDash), score 0-100


Secondary Outcome Measures :
  1. Change of Visual analogue scale [ Time Frame: 2 years ]
    Visual analogue scale: scale 0-10

  2. Shoulder range of motion improvement [ Time Frame: 2 years ]
    Range of motion improvement: flexion, abduction, external rotation (degree)

  3. Stiffness of coracohumeral ligament under elastogram (KPa) [ Time Frame: 2 years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

A.Inclusion criteria:

  1. Age 20-80 years old
  2. Unilateral shoulder pain more than 3 months
  3. At least one shoulder ROM limitation in three dimensions which decreased over 50% (Abduction, Flexion, External rotation)
  4. Visual analog scale more than 30 (total 100)
  5. No fracture or subluxation or arthritis in shoulder Xray.

B.Exclusion criteria:

  1. History of shoulder or chest surgery
  2. History of shoulder trauma in 2 recent years
  3. Ever receiving shoulder joint injection in recent 3 months
  4. With cervical radiculopathy or any central CNS disorders
  5. With osteoarthritis or rheumatic arthritis of shoulder
  6. Diagnosed as rotator cuff tear, tendon calcification or bursitis
  7. Systemic diseases including diabetes or thyroid disorder
  8. Allergy history of steroid

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): NCT03013205


Contacts
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Contact: Chueh-Hung Wu 0972651208 nojred@gmail.com

Locations
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Taiwan
National Taiwan University Hospital Not yet recruiting
Test1, Test2, Taiwan, test3
Contact: Chueh-Hung Wu , MD    0972651208    nojred@gmail.com   
Sponsors and Collaborators
National Taiwan University Hospital
Investigators
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Principal Investigator: Chueh-Hung Wu, MD NTUH PMR

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Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT03013205     History of Changes
Other Study ID Numbers: 201609026RINB
First Posted: January 6, 2017    Key Record Dates
Last Update Posted: January 6, 2017
Last Verified: January 2017
Keywords provided by National Taiwan University Hospital:
adhesive capsulitis
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
Lidocaine
Triamcinolone diacetate
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Immunosuppressive Agents
Immunologic Factors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators