Comparison of Rotator Interval Injection Versus Intraarticular Hydrodilatation in Frozen Shoulder

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

Study Overview

• Status: Completed
• Conditions: Adhesive Capsulitis
• Intervention / Treatment: Drug: Triamcinolone (Shincort) injection to rotator interval; Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recess

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 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.

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Taiwan
  • Taipei, Taiwan, 241
    • Taipei Veterans General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 or corticosteroid
5. pregnancy or lactation;
6. received injection into the affected shoulder during the preceding 3 months
7. history of surgeries on the affected shoulders
8. Secondary frozen shoulder

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: rotator interval injection; patient received ultrasound-guided steroid injection via rotator interval	Drug: Triamcinolone (Shincort) injection to rotator interval; via rotator interval.
ACTIVE_COMPARATOR: posterior recess injection; patient received ultrasound-guided steroid injection via posterior recess	Drug: Triamcinolone (Shincort) injection to posterior glenuhumeral recess; via posterior glenuhumeral recess

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Shoulder Pain And disability index	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	Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
pain intensity	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.	Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline
glenohumeral joint range of motion	Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position	Change at baseline, 6 weeks, 12 weeks

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (ACTUAL): September 28, 2018
• Primary Completion (ACTUAL): January 15, 2021
• Study Completion (ACTUAL): March 15, 2021

Study Registration Dates

• First Submitted: September 9, 2018
• First Submitted That Met QC Criteria: September 17, 2018
• First Posted (ACTUAL): September 19, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 28, 2021
• Last Update Submitted That Met QC Criteria: April 27, 2021
• Last Verified: April 1, 2021

More Information

Terms related to this study

• Keywords: adhesive capsulitis
• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Enzyme Inhibitors; Anti-Inflammatory Agents; Immunosuppressive Agents; Immunologic Factors; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Triamcinolone diacetate
• Other Study ID Numbers: 2018-07-008B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No