Comparison of the Short-term Clinical Effects of Anterior Extra-articular and Posterior Intra-articular Administration of Ultrasound-guided Steroid Injection in the Treatment of Adhesive Capsulitis.

NCT ID: NCT05668286

Last Updated: 2024-03-06

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-05-24
• Study Completion Date: 2024-12-24

Brief Summary

In the treatment of adhesive capsulitis, conservative treatment usually gives successful results, and steroid injection is an effective method that is frequently preferred among conservative treatment modalities. However, many controversial issues have not yet been clarified in the literature, such as the location of the injection, whether into the glenohumeral joint or around the coracohumeral ligament where the most radiological findings are detected.

Detailed Description

Purpose:

To compare the intra-articular steroid administration with the extra-articular one; around the coracohumeral ligament in patients with adhesive capsulitis.

Method:

Ethics committee approval was obtained for the study. Patients who were diagnosed with adhesive capsulitis in the orthopedic outpatient clinic were included. Diagnosis was confimed by physical examination and Magnetic Resonance Imaging (MRI) findings. Patients with radiological finding of any tear in the rotator cuff or long head of biceps tendons were excluded. Only patients in the freezing or frozen stage of the disease were included. Patients who were previously treated with the diagnosis of adhesive caspulitis or who received any injections to the shoulder joint were not included in the study. Included patients were randomly divided into two groups according to age, sex, duration of complaint, concomitant diabetes mellitus (DM) disease and clinical stage of the disease. For randomization, stratified randomization was applied according to the information obtained from the outpatient clinic. While patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients. Patients were first evaluated before injection, than randomized to groups and prospectively followed up by an orthopaedic surgeon who was blinded to the groups. Evaluation was done for pain (visual analog scale score; VAS), functional status (American Shoulder and Elbow Surgeons score; ASES and Quick Disabilities of the Arm, Shoulder and Hand; Quick DASH), and active shoulder joint range of motion (ROM) angles at 1, 3, and 6 weeks after the injection. Means and standard deviations of were noted for each measurement period and each group. Improvements in each period between the groups and differences between the preinjection values and each follow-up period between the groups were analyzed using Ficher exact test, independent-samples t tests and Manova test. P < .05 was considered significant.

Conditions

Adhesive Capsulitis of the Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

posterior intra-articular steroid injection under USG guidance

Intra-articular steroid injection will be performed to the glenohumeral joint from the posterior, 2cm inferior and 2cm medial of the acromion posterolateral corner, under the guidance of USG.

Group Type: ACTIVE_COMPARATOR

A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)

Intervention Type: DRUG

patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients.

anterior extra-articular steroid injection under USG guidance

Steroid injection will be performed from the anterior, immediately lateral to the coracoid process, to the CHL localization, to the extra-articular area under the guidance of USG.

Group Type: ACTIVE_COMPARATOR

A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)

Intervention Type: DRUG

patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients.

Interventions

A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%)

patients in group 1 received an anterior extra-articular steroid injection under USG guidance, patients in group 2 received posterior intra-articular steroid injection under USG guidance. A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) were injected to all patients.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• must be between the ages of 18-75
• clinically and radiologically confirmed adhesive capsulitis

Exclusion Criteria

• Patients with a tear in any of the rotator cuff tendons
• Patients who have had steroid injections in the shoulder region before
• patients who have been treated with the diagnosis of adhesive capsulitis (except for oral non-steroidal anti-inflammatory drug therapy)
• Patients with a previous history of trauma-fracture-dislocation in the shoulder region

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kartal City Hospital

OTHER

Sponsor Role: lead

Responsible Party

Omer Faruk Sevim, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

Site Status: RECRUITING

Countries

Turkey (Türkiye)

Central Contacts

OMER FARUK SEVIM, MD

Role: CONTACT

dromerfaruksevim@gmail.com

+905382884306

Facility Contacts

Omer Faruk Sevim

Role: primary

dromerfaruksevim@gmail.com

+905382884306

Selim Ergun

Role: backup

drselimergun@gmail.com

‭+90 533 601 14 72‬

Other Identifiers

KartalCity-ERGUN-001

Identifier Type: -

Identifier Source: org_study_id