Has Ultrasound-guided Hydrorelease of Coracohumeral Ligamet Additional Benefit in Patients With Adhesive Capsulitis Receiving Ultrasound-guided Shoulder Hyrodilatation?

NCT06202963 | Completed DMC

• 1 other identifier: HNEAH-KAEK/KK/2023/210
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this study is to detect if there is an additional benefit to performing ultrasound-guided hydrorelease of the coracohumeral ligament in patients with adhesive capsulitis of the shoulder receiving ultrasound-guided hydrodilatation.

Conditions

Adhesive Capsulitis

Keywords

Adhesive Capsulitis, Coracohumeral ligament, Hydrorelease, Hydrodilatation

Outcome Measures

Primary Outcomes (3)

• Visual Analouge Scale (VAS)

  Pain Severity

  Before and immediately after injection, 1 week,1 month and 2 moths after injection

• Shoulder Range of Motion

  Shoulder Limitation

  Before and immediately after injection, 1 week,1 month and 2 moths after injection

• Shoulder Disability Index

  Shouler Disability

  Before injection, 1 week,1 month and 2 moths after injection

Study Arms (2)

Group 1

ACTIVE COMPARATOR

In group 1, hydrodilatation will be performed with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. Fluid injection will continue until distension is observed in the shoulder joint capsule by ultrasonography. The amount of fluid given will be recorded.

Drug: Triamcinolone Acetonide

Group 2

ACTIVE COMPARATOR

The second group will undergo hydrodilatation with intra-articular 40 mg triamcinolone, lidocaine, and physiological saline through a posterior approach to the shoulder, guided by ultrasonographic imaging. The amount of fluid given will be recorded. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.

Drug: Triamcinolone Acetonide

Interventions

Triamcinolone Acetonide DRUG

1. group will receive ultrasound-guided hydrodilatation 2. group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder

Also known as: lidocaine, serum physiologic

Group 1; Group 2

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients between the ages of 30 and 70 who have complained of shoulder pain and limitation in the shoulder for at least 3 months and have been diagnosed with adhesive capsulitis by clinical examination will be included in the study.

You may not qualify if:

• A history of physical therapy or injections for the shoulder joint within the previous three months,
• The existence of a neurological condition or surgical history that could impair upper limb functions,
• Being a breastfeeding or pregnant woman,
• Mental illnesses and cognitive impairments that impair cooperation
• Diabetes mellitus with unregulated glucose levels
• Presence of Cancer

Sponsors & Collaborators

• Haydarpasa Numune Training and Research Hospital: lead

Study Sites (1)

Health Science University Haydarpasa Numune Research and Training Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Bursitis

Interventions

Triamcinolone Acetonide; Lidocaine

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Intervention Hierarchy (Ancestors)

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Study Record Dates

• First Submitted: January 2, 2024
• First Posted: January 12, 2024
• Study Start: December 18, 2023
• Primary Completion: March 15, 2025
• Study Completion: March 15, 2025
• Last Updated: April 2, 2025

Record last verified: 2025-03

Locations

TU (1)