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Completed

NCT Number: NCT06202963

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

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.

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Key information

Age range

30 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Health Science University Haydarpasa Numune Research and Training Hospital

Istanbul, Uskudar, 34668, Turkey (Türkiye)

About this study

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

  • 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
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

  • 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

Treatment and study plan

Triamcinolone Acetonide

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

Other names: lidocaine, serum physiologic

Primary outcomes

  1. Visual Analouge Scale (VAS)

    Time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection

    Pain Severity

  2. Shoulder Range of Motion

    Time frame: Before and immediately after injection, 1 week,1 month and 2 moths after injection

    Shoulder Limitation

  3. Shoulder Disability Index

    Time frame: Before injection, 1 week,1 month and 2 moths after injection

    Shouler Disability

Sponsors and collaborators

Lead sponsor

Haydarpasa Numune Training and Research Hospital

Other

Registry information

Important dates

Study start
2023
Primary completion
2025
Study completion
2025
First posted
Jan 12, 2024
Registry last updated
Apr 2, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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