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.

NCT05668286 | Recruiting

• 1 other identifier: KartalCity-ERGUN-001
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of the Shoulder

Keywords

adhesive capsulitis; steroid injection; ultrasound-guided

Outcome Measures

Primary Outcomes (5)

• The Visual Analogue Scale(VAS)

  The change of Visual Analogue Scale (VAS) measures pain intensity. The VAS consists of a 10cm line, with two end points representing 0 ('no pain') and 10 ('pain as bad as it could possibly be'). Ask the patient to rate their current level of pain by placing a mark on the line.We noted the changes within this scoring system between the time framed which is stated below

  The change from the baseline of the Visual Analog Scale (VAS) score of the shoulder pain in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.

• external rotation of shoulder

  The change of external rotation of the shoulder will be measured by the Orthopedic Resident by goniometer.

  The change from the baseline of external rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.

• abduction of shoulder

  The change of abduction of the shoulder will be measured by the Orthopedic Resident by goniometer.

  The change in shoulder abduction from the baseline over a 6-week period Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.

• flexion of shoulder

  The change of flexion of the shoulder will be measured by the Orthopedic Resident by a goniometer.

  The change from the baseline of flexion of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.

• Internal rotation of the shoulder

  The change of Internal rotation of the shoulder will be measured by the Orthopedic Resident by Constant Shoulder Score

  The change from the baseline of internal rotation of the shoulder in a period of 6 weeks Measurements will be taken at pre-medication, post-med 1.week, post-med 3.week, and post-med 6.week.

Study Arms (2)

posterior intra-articular steroid injection under USG guidance

ACTIVE COMPARATOR

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.

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

anterior extra-articular steroid injection under USG guidance

ACTIVE COMPARATOR

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.

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

Interventions

A combination of 1 mL of triamcinolone acetonide (40 mg/mL) and 1 mL of prilocaine hydrochloride (2%) 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; posterior intra-articular steroid injection under USG guidance

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Kartal City Hospital: lead

Study Sites (1)

Kartal Dr Lutfi Kirdar City Hospital

Istanbul, Kartal, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone Acetonide; Prilocaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Triamcinolone; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Steroids, Fluorinated; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Central Study Contacts

OMER FARUK SEVIM, MD

CONTACT

+905382884306; dromerfaruksevim@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Patients who are diagnosed with adhesive capsulitis in the orthopedic outpatient clinic will be included. Included patients will be randomly divided into two groups according to age, sex, concomitant diabetes mellitus (DM) disease and clinical stage of the disease. For randomization, stratified randomization will be 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.1 mL of triamcinolone acetonide and 1 mL of prilocaine hydrochloride (2%) will be injected to all patients. Patients will be first evaluated before injection, than randomized to groups and prospectively followed up by an orthopaedic surgeon who will be blinded to the groups. Evaluation will be done for pain VAS, functional status ;ASES and Quick DASH at 1,3 and 6 weeks after the injection.

Study Record Dates

• First Submitted: May 16, 2022
• First Posted: December 29, 2022
• Study Start: May 24, 2024
• Primary Completion: November 24, 2024
• Study Completion: December 24, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: There will be no time limitations on data monitoring

Locations

TU (1)