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

Not Applicable

Recruiting

• Conditions: Shoulder Pain

• Registration Number: NCT06888791
• Lead Sponsor: Diskapi Teaching and Research Hospital

Brief Summary

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

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

Study Timeline

• Study Start: 2025-02-25
• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Primary Completion: 2025-09-25
• Study Completion: 2025-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Visual analog scale (VAS)	Change from baseline to 1st and 3rd month after treatment	VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

Secondary Outcome Measures

Name	Time	Method
Shoulder Pain and Disability Index (SPADI)	Change from baseline to 1st and 3rd month after treatment	SPADI is a self-report questionnaire developed to evaluate patients with shoulder problems. The pain subscale has 5-items and the disability subscale has 8-items.The total score ranges from 0 to 100, with higher scores indicating better outcomes.

Trial Locations

Locations (1)

Diskapi Training and Research Hospital; 🇹🇷 Ankara, Turkey