Ultrasound-guided Anterior Hydrodilatation in Shoulder Adhesive Capsulitis

Study Overview
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Brief Summary
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A prospective randomized controlled study among 60 consecutive adhesive capsulitis to compare between the ultrasound-guided anterior hydrodilatation in rotator interval and the posterior approach.

Detailed Description
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patients was randomized into two equal groups. Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach; group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach. Both groups received guided stretching exercises for 3 months after injection. Baseline and 3 months evaluation of pain by visual analogue scale (VAS), shoulder pain and disability index (SPADI), and range of motion (ROM) had been recorded for all patients. A statistical power analysis was performed after sample size estimation, based on data from the current study (N = 60), comparing group I to group II. Qualitative data was expressed as numbers and percentages, and Chi-squared test, Quantitative data were expressed as mean and standard deviation.

Official Title
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In Shoulder Adhesive Capsulitis, Ultrasound-guided Anterior Hydrodilatation in Rotator Interval is More Effective Than Posterior Approach: a Randomized Controlled Study

Conditions
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Shoulder Capsulitis

Intervention / Treatment
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* Procedure: ultrasound-guided posterior hydrodilatation
* Drug: corticosteroid, saline, and local anesthetic
* Other: guided stretching and strengthening exercise program


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients aged 35 to 60 years, patients who suffered pain and stiffness in only one shoulder, for 1 to 6 months patients who had restriction of passive motion. Exclusion Criteria: patients with previous trauma, patients with neurological patients with endocrinal diseases patients with shoulder tumor patients with arthritis people who had received intra-articular shoulder injection within the last 6 months. Patients with tendon tear

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group 1<br>Group I received ultrasound-guided hydrodilatation with corticosteroid, saline, and local anesthetic via posterior intra-articular approach | Procedure: ultrasound-guided posterior hydrodilatation<br>* Group I was treated through posterior approach; The injection needle is introduced at the skin surface just lateral to the transducer and in an oblique lateral to medial direction. Group II was treated through anterior rotator interval approach. A 21-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial, the needle tip is imaged in real time throughout its passage from superficial to deep and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. Both groups were given the same guided stretching and strengthening exercise program<br>Drug: corticosteroid, saline, and local anesthetic<br>* corticosteroid, saline, and local anesthetic<br>Other: guided stretching and strengthening exercise program<br>* guided stretching and strengthening exercise program<br>|
| Experimental: group 2<br>group II received the same ultrasound-guided hydrodilatation via anterior rotator interval approach | Procedure: ultrasound-guided posterior hydrodilatation<br>* Group I was treated through posterior approach; The injection needle is introduced at the skin surface just lateral to the transducer and in an oblique lateral to medial direction. Group II was treated through anterior rotator interval approach. A 21-gauge needle is introduced into the rotator interval using an oblique path within the imaging plane of the transducer; from lateral to medial, the needle tip is imaged in real time throughout its passage from superficial to deep and is positioned in the biceps tendon sheath between the coracohumeral ligament above and biceps tendon below. Both groups were given the same guided stretching and strengthening exercise program<br>Other: guided stretching and strengthening exercise program<br>* guided stretching and strengthening exercise program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analoge state | minimum value: 0 maximum value: 10 higher scores mean a worse outcome. | 3 months | 
| shoulder pain and disability index | minimum value: 0 maximum value: 100 higher scores mean a worse outcome. | 3 months |