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

ConditionShoulder Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorDiskapi Teaching and Research Hospital

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Diagnosis of frozen shoulder disease

VAS>5

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • US-guided Hydro Dissection

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

44 Participants
are divided into 2 treatment groups
Group A: US-guided Hydro DissectionActive comparator 1 intervention
Group B: Fluoroscopy-guided Hydro DissectionActive comparator 1 intervention

Trial outcomes

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)

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

Secondary outcomes

1

Shoulder Pain and Disability Index (SPADI)

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.

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

Other outcomes

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