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Trial record 27 of 52 for:    "Frozen Shoulder"

Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder

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ClinicalTrials.gov Identifier: NCT03678038
Recruitment Status : Recruiting
First Posted : September 19, 2018
Last Update Posted : October 24, 2018
Sponsor:
Information provided by (Responsible Party):
Taipei Veterans General Hospital, Taiwan

Brief Summary:
This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus rotator interval approach for treating patients with adhesive capsulitis.

Condition or disease Intervention/treatment Phase
Adhesive Capsulitis Drug: triamcinolone, shincort Not Applicable

Detailed Description:

Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis.

Design: a prospective, single-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 ( ultrasound guided rotator interval injection ) and group 2 (ultrasound guided steroid hydrodilatation). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, Constant shoulder score, and Shoulder Pain And Disability Index.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparing the Efficacy of Rotator Interval Steroid Injection Versus Steroid Intraarticular Hydrodilatation in the Treatment of Frozen Shoulder
Actual Study Start Date : September 28, 2018
Estimated Primary Completion Date : November 1, 2019
Estimated Study Completion Date : November 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: rotator interval injection
patient received ultrasound-guided steroid injection via rotator interval
Drug: triamcinolone, shincort
via rotator interval.

Active Comparator: posterior recess injection
patient received ultrasound-guided steroid injection via posterior recess
Drug: triamcinolone, shincort
via rotator interval posterior recess




Primary Outcome Measures :
  1. constant shoulder score [ Time Frame: 12 weeks ]
    the total constant score ranges from 0 to 100 points, with higher scores indicative of better function. The score is divided into four sections: pain, activity of daily living, ROM and strength


Secondary Outcome Measures :
  1. pain intensity [ Time Frame: 0, 6, 12 weeks ]
    pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain.

  2. Shoulder Pain And disability index [ Time Frame: 0, 6, 12 weeks ]
    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. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.

  3. glenohumeral joint range of motion [ Time Frame: 0, 6, 12 weeks ]
    Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position



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Ages Eligible for Study:   35 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion Criteria:

  1. other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region);
  2. neurologic deficits affecting shoulder function in normal daily activities;
  3. shoulder pain caused by cervical radiculopathy
  4. a history of drug allergy to xylocaine
  5. pregnancy or lactation;
  6. received injection into the affected shoulder during the preceding 3 months

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): NCT03678038


Contacts
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Contact: Jia chi Wang 0919527693 jcwang0726@gmail.com

Locations
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Taiwan
Taipei Veterans General Hospital Recruiting
Taipei, Taiwan, 241
Contact: Jia c Wang, MD    919527693    jcwang0726@gmail.com   
Sponsors and Collaborators
Taipei Veterans General Hospital, Taiwan

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Responsible Party: Taipei Veterans General Hospital, Taiwan
ClinicalTrials.gov Identifier: NCT03678038     History of Changes
Other Study ID Numbers: 2018-07-008B
First Posted: September 19, 2018    Key Record Dates
Last Update Posted: October 24, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Taipei Veterans General Hospital, Taiwan:
adhesive capsulitis
Additional relevant MeSH terms:
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Bursitis
Joint Diseases
Musculoskeletal Diseases
Triamcinolone
Triamcinolone Acetonide
Triamcinolone hexacetonide
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