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

Diskapi Teaching and Research Hospital

Status: Enrolling

Conditions: Shoulder Pain

Treatments: Procedure: US-guided Hydro Dissection; Procedure: Fluoroscopy-guided Hydro Dissection

Study type: Interventional

Funder types: Other

Identifiers

NCT06888791

US-guided vs fluoro-guided HD

Details and patient eligibility

About

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.

Full description

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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

US-guided Hydro Dissection

Active Comparator group

Description:

US-guided hydro dissection for adhesive capsulitis

Treatment:

Procedure: US-guided Hydro Dissection

Fluoroscopy-guided Hydro Dissection

Active Comparator group

Description:

Fluoroscopy-guided hydro dissection for adhesive capsulitis

Treatment:

Procedure: Fluoroscopy-guided Hydro Dissection