US-guided Hydro Dissection vs Fluoroscopy-guided Hydro Dissection for Adhesive Capsulitis
Is Hydro Dissection Treatment More Successful With Ultrasonography or Fluoroscopy in the Management of Adhesive Capsulitis?
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: AYSE BETUL ACAR
- Phone Number: TR +905326685180
- Email: betulbozann@gmail.com
Study Contact Backup
- Name: Gokhan YILDIZ
- Phone Number: +905059272589
- Email: gkoyldz@gmail.com
Study Locations
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Ankara, Turkey, 06500
- Recruiting
- Diskapi Training and Research Hospital
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Contact:
- Gokhan YILDIZ
- Phone Number: TR +905059272589
- Email: gkoyldz@gmial.com
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Active Comparator: US-guided Hydro Dissection
US-guided hydro dissection for adhesive capsulitis
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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.
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Active Comparator: Fluoroscopy-guided Hydro Dissection
Fluoroscopy-guided hydro dissection for adhesive capsulitis
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Visual analog scale (VAS)
Time Frame: Change from baseline to 1st and 3rd month after treatment
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VAS is a scale that can be used measuring pain.
Scores range from 0 (no pain) to 10 (the worst pain)
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Change from baseline to 1st and 3rd month after treatment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Shoulder Pain and Disability Index (SPADI)
Time Frame: Change from baseline to 1st and 3rd month after treatment
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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.
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Change from baseline to 1st and 3rd month after treatment
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Collaborators and Investigators
Investigators
- Study Chair: Gevher Rabia Genc Perdecioğlu, Diskapi TRH
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- US-guided vs fluoro-guided HD
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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