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

NCT ID: NCT06202963

Last Updated: 2025-04-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 63 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-12-18
• Study Completion Date: 2025-03-15

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.

Detailed Description

This study is organised as double-blind, randomised controlled trial. Written informed consent will be taken from all the patients participating to the study.

Inclusion Criteria

Patients between the ages of 30 and 70, who have complaints of shoulder pain and limitation in the shoulder for at least 3 months and are diagnosed with Adhesive Capsulitis by clinical examination, will be included in the study.

Exlusion Criteria

1. A history of physical therapy or injections for the shoulder joint within the previous three months,

2. The existence of a neurological condition or surgical history that could impair upper limb functions,

3. Being a breastfeeding or pregnant woman,

4. Mental illnesses and cognitive impairments that impair cooperation

5. Diabetes mellitus with unregulated glucose levels

6. Presenece of Cancer

Patients included in the study will be divided into two groups by block randomization.

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.

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. Additionally, with ultrasonographic evaluation, 2 cc of physiological saline will be injected into the corocohumeral ligament.

All the patients will be evaluated by a doctor who is blind to the study groups. Demographic information, history of shoulder pain, presence of chronic diseases, pain severity measured by VAS during resting,activity and sleep will be recorded. Physical examination including shoulder range of motion, will be evaluated. Shoulder Disability Index will be used for evaluating the functional status of shoulder. They will be evaluated before and immediately after injection, 1 week later, 1 month and 3 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.

Conditions

Adhesive Capsulitis

Study Design

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

Study Groups

Group 1

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.

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: 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

Group 2

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.

Group Type: ACTIVE_COMPARATOR

Triamcinolone Acetonide

Intervention Type: 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

Interventions

Triamcinolone Acetonide

1. group will receive ultrasound-guided hydrodilatation

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

Intervention Type: DRUG

Other Intervention Names

lidocaine; serum physiologic

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

1. A history of physical therapy or injections for the shoulder joint within the previous three months,

2. The existence of a neurological condition or surgical history that could impair upper limb functions,

3. Being a breastfeeding or pregnant woman,

4. Mental illnesses and cognitive impairments that impair cooperation

5. Diabetes mellitus with unregulated glucose levels

6. Presence of Cancer

• Minimum Eligible Age: 30 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Haydarpasa Numune Training and Research Hospital

OTHER

Sponsor Role: lead

Responsible Party

Sibel süzen Özbayrak

M.D.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Health Science University Haydarpasa Numune Research and Training Hospital

Istanbul, Uskudar, Turkey (Türkiye)

Countries

Turkey (Türkiye)

Other Identifiers

HNEAH-KAEK/KK/2023/210

Identifier Type: -

Identifier Source: org_study_id