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

NCT06888791 | Recruiting

• 1 other identifier: US-guided vs fluoro-guided HD
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Shoulder Pain

Keywords

Nerve Block; Fluoroscopy; Pain Management

Outcome Measures

Primary Outcomes (1)

• Visual analog scale (VAS)

  VAS is a scale that can be used measuring pain. Scores range from 0 (no pain) to 10 (the worst pain)

  Change from baseline to 1st and 3rd month after treatment

Secondary Outcomes (1)

• Shoulder Pain and Disability Index (SPADI)

  Change from baseline to 1st and 3rd month after treatment

Study Arms (2)

US-guided Hydro Dissection

ACTIVE COMPARATOR

US-guided hydro dissection for adhesive capsulitis

Procedure: US-guided Hydro Dissection

Fluoroscopy-guided Hydro Dissection

ACTIVE COMPARATOR

Fluoroscopy-guided hydro dissection for adhesive capsulitis

Procedure: Fluoroscopy-guided Hydro Dissection

Interventions

US-guided Hydro Dissection 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.

US-guided Hydro Dissection

Fluoroscopy-guided Hydro Dissection 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.

Fluoroscopy-guided Hydro Dissection

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of frozen shoulder disease
• VAS\>5

You may not qualify if:

• 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

Sponsors & Collaborators

• Diskapi Teaching and Research Hospital: lead

Study Sites (1)

Diskapi Training and Research Hospital

Ankara, 06500, Turkey (Türkiye)

RECRUITING

MeSH Terms

Conditions

Shoulder Pain; Agnosia

Condition Hierarchy (Ancestors)

Arthralgia; Joint Diseases; Musculoskeletal Diseases; Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Officials

• Gevher Rabia Genc Perdecioğlu

  Diskapi TRH

  STUDY CHAIR

Central Study Contacts

AYSE BETUL ACAR

CONTACT

+905326685180; betulbozann@gmail.com

Gokhan YILDIZ

CONTACT

+905059272589; gkoyldz@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Supervisor Investigator

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: February 25, 2025
• Primary Completion: September 25, 2025
• Study Completion: December 30, 2025
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

TU (1)