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

Adhesive Capsulitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06202963
• Other study ID #: HNEAH-KAEK/KK/2023/210
• Status: Recruiting
• Phase: N/A
• Start date: December 18, 2023
• Est. completion date: July 30, 2024

Study information

• Verified date: January 2024
• Source: Haydarpasa Numune Training and Research Hospital
• Contact: Sibel Suzen Ozbayrak, M.D.
• Phone: +905063438187
• Email: sibels62[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 2 months after injection with VAS, shoulder range of motion and Shoulder Disability Index.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: July 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Adhesive Capsulitis
• Bursitis

Intervention

Drug:
• Triamcinolone Acetonide
group will receive ultrasound-guided hydrodilatation group will receive ultarsound-guided coracohumeral hydrorelease in addition to the ultrasound-guided hydrodilaltation of shoulder

Locations

Country	Name	City	State
Turkey	Health Science University Haydarpasa Numune Research and Training Hospital	Istanbul	Uskudar

Sponsors (1)

Lead Sponsor	Collaborator
Haydarpasa Numune Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual Analouge Scale (VAS)	Pain Severity	Before and immediately after injection, 1 week,1 month and 2 moths after injection
Primary	Shoulder Range of Motion	Shoulder Limitation	Before and immediately after injection, 1 week,1 month and 2 moths after injection
Primary	Shoulder Disability Index	Shouler Disability	Before injection, 1 week,1 month and 2 moths after injection