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NCT Number: NCT03678038

Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

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.

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Key information

Age range

35 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Taipei Veterans General Hospital

Taipei, 241, Taiwan

About this study

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 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.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Diagnosis of frozen shoulder by physical examination and ultrasonography

Exclusion criteria

  • other conditions involving the shoulder ( rheumatoid arthritis, Hill-Sachs lesions,osteoporosis, or malignancies in the shoulder region)
  • neurologic deficits affecting shoulder function in normal daily activities
  • shoulder pain caused by cervical radiculopathy
  • a history of drug allergy to xylocaine or corticosteroid
  • pregnancy or lactation;
  • received injection into the affected shoulder during the preceding 3 months
  • history of surgeries on the affected shoulders
  • Secondary frozen shoulder

Treatment and study plan

Triamcinolone (Shincort) injection to rotator interval

Drug

via rotator interval.

Triamcinolone (Shincort) injection to posterior glenuhumeral recess

Drug

via posterior glenuhumeral recess

Primary outcomes

  1. Shoulder Pain And disability index

    Time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline

    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.function. The score is divided into four sections: pain, activity of daily living, ROM and strength

Secondary outcomes

  1. pain intensity

    Time frame: Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline

    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. glenohumeral joint range of motion

    Time frame: Change at baseline, 6 weeks, 12 weeks

    Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position

Sponsors and collaborators

Lead sponsor

Taipei Veterans General Hospital, Taiwan

Other Gov

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2021
Study completion
2021
First posted
Sep 19, 2018
Registry last updated
Apr 28, 2021

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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