US-guided Hydro Dissection vs Fluoroscopy-guided Hydro Dissection for Adhesive Capsulitis

NCT ID: NCT06888791

Last Updated: 2025-03-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-02-25

Study Completion Date

2025-12-30

Brief Summary

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This study aims to evaluate the differences in joint range of motion, Visual Analog Scale (VAS) scores, and the Shoulder Pain and Disability Index (SPADI) outcomes in patients with adhesive capsulitis (frozen shoulder) who undergo hydrodilatation therapy with either ultrasound (USG) or fluoroscopy guidance, in addition to a suprascapular nerve block.

Detailed Description

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Adhesive capsulitis is a common condition characterized by painful restriction of both active and passive glenohumeral movement, especially when joint degeneration alone is insufficient to explain the limitation. The condition is more prevalent in women and has a strong correlation with diabetes mellitus and thyroid dysfunction. The prevalence in the general population is approximately 3-5%, but it can reach up to 20% in diabetic patients.

The primary goals of treatment are to alleviate pain, improve mobility, shorten symptom duration, and facilitate a return to normal activities. The suprascapular nerve is a major sensory nerve for the posterior and superior aspects of the shoulder and is an accessible target for blockade. Conditions in which suprascapular nerve block is used include chronic shoulder pain syndromes such as rheumatoid arthritis, glenohumeral osteoarthritis, post-stroke shoulder pain, motor neuron disease-related shoulder pain, and various rotator cuff disorders.

Hydrodilatation therapy works by releasing the contracted joint capsule and reducing fibrosis, while corticosteroids exert strong anti-inflammatory effects throughout the shoulder joint. The high-pressure transmission mechanism used in hydrodilatation enhances the distribution of corticosteroids throughout the glenohumeral joint capsule. The procedure involves injecting fluid into the joint cavity under radiological guidance using either ultrasound or fluoroscopy.

This study aims to determine whether performing hydrodilatation under ultrasound versus fluoroscopy guidance in addition to suprascapular nerve block leads to differences in joint range of motion, VAS scores, and SPADI disability index outcomes in patients diagnosed with adhesive capsulitis. Assessments will be performed before the procedure, on the day of the procedure, and at the 3rd month

Conditions

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Shoulder Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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US-guided Hydro Dissection

US-guided hydro dissection for adhesive capsulitis

Group Type ACTIVE_COMPARATOR

US-guided Hydro Dissection

Intervention Type PROCEDURE

All procedures are performed under sterile conditions. The patient is seated in a sitting position with the physician behind the patient, the shoulder joint and the surrounding area is cleaned extensively with 10% povidone iodine. The probe is placed in the posterior lateral region of the shoulder, below the level of the scapular spine. The posterior labrum is observed as a triangular hyperechoic structure extending from the glenoid to the humeral head. A 22 G spinal needle is inserted approximately 1 cm medial to the probe along the axis of the spina scapula and 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline is slowly injected into the joint in a total of 20 mL into the glenohumeral region. For suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure.

Fluoroscopy-guided Hydro Dissection

Fluoroscopy-guided hydro dissection for adhesive capsulitis

Group Type ACTIVE_COMPARATOR

Fluoroscopy-guided Hydro Dissection

Intervention Type PROCEDURE

The patient is placed on the scope table in supine position and the shoulder joint is cleaned with 10% povidone iodine. The acromioclavicular joint and the glenohumeral joint are visualized using C-arm fluoroscopy with anteroposterior view. The acromioclavicular joint is marked as the entry point to the shoulder joint. After the skin and subcutaneous tissue is anesthetized with 1 cc 2% lidocaine with a 27 G needle, a 22 G spinal needle is inserted through the acromioclavicular joint and the needle is directed towards the glenohumeral joint. With 1 ml of contrast medium, the localization of the needle is confirmed. After appropriate spread of contrast agent, 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline are administered into the joint in a total of 20 mL. For US-guided suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure.

Interventions

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US-guided Hydro Dissection

All procedures are performed under sterile conditions. The patient is seated in a sitting position with the physician behind the patient, the shoulder joint and the surrounding area is cleaned extensively with 10% povidone iodine. The probe is placed in the posterior lateral region of the shoulder, below the level of the scapular spine. The posterior labrum is observed as a triangular hyperechoic structure extending from the glenoid to the humeral head. A 22 G spinal needle is inserted approximately 1 cm medial to the probe along the axis of the spina scapula and 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline is slowly injected into the joint in a total of 20 mL into the glenohumeral region. For suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure.

Intervention Type PROCEDURE

Fluoroscopy-guided Hydro Dissection

The patient is placed on the scope table in supine position and the shoulder joint is cleaned with 10% povidone iodine. The acromioclavicular joint and the glenohumeral joint are visualized using C-arm fluoroscopy with anteroposterior view. The acromioclavicular joint is marked as the entry point to the shoulder joint. After the skin and subcutaneous tissue is anesthetized with 1 cc 2% lidocaine with a 27 G needle, a 22 G spinal needle is inserted through the acromioclavicular joint and the needle is directed towards the glenohumeral joint. With 1 ml of contrast medium, the localization of the needle is confirmed. After appropriate spread of contrast agent, 8 mg (2 mL) dexamethasone, 80 mg (4 mL) 2% lidocaine, 14 mL 0.9% saline are administered into the joint in a total of 20 mL. For US-guided suprascapular nerve block, 2 ml 0.5% bupivacaine + 2 ml 0.9% saline is administered. Patients are followed up in the recovery unit for 30 minutes after the procedure.

Intervention Type PROCEDURE

Eligibility Criteria

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Inclusion Criteria

* Diagnosis of frozen shoulder disease
* VAS\>5

Exclusion Criteria

* Other shoulder diseases that may cause shoulder pain (Rotator cuff tear, clavicle fracture, etc.)
* Allergy to local anesthetics
* History of shoulder surgery in the last 12 months
* Pregnancy
* Coagulopathy or antiplatelet use
* The patient has a mental illness that prevents decision-making
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Diskapi Teaching and Research Hospital

OTHER

Sponsor Role lead

Responsible Party

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Damla Yürük

Supervisor Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Gevher Rabia Genc Perdecioğlu

Role: STUDY_CHAIR

Diskapi TRH

Locations

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Diskapi Training and Research Hospital

Ankara, , Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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AYSE BETUL ACAR

Role: CONTACT

+905326685180 ext. TR

Gokhan YILDIZ

Role: CONTACT

+905059272589

Facility Contacts

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Gokhan YILDIZ

Role: primary

+905059272589 ext. TR

Other Identifiers

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US-guided vs fluoro-guided HD

Identifier Type: -

Identifier Source: org_study_id

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