Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit in Treating Patients With Adhesive Capsulitis

Study Overview
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Brief Summary
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This study was conducted to compare the efficacy of hydrodilatation with steroid via posterior approach versus hydrodilatation with steroid with axillary nerve injection for treating patients with adhesive capsulitis.

Detailed Description
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Adhesive capsulitis is a common cause of shoulder pain, and the efficacy of most interventions is limited. This study was conducted to compare the efficacy of rotator interval injection with steroid with that of steroid hydrodilatatoin for treating adhesive capsulitis. Design: a prospective, single-blinded, randomized, clinical trial Patient and methods: Patients with adhesive capsulitis were enrolled and randomly allocated into group 1 ( ultrasound guided hydrodilatation with steroid via posterior approach) and group 2 (ultrasound guided hydrodilatation with steroid via posterior approach as well as axillary nerve injection). The patients were evaluated before treatment and were reevaluated 0, 6, and 12 weeks after the beginning of the treatment. Outcomes measures included a pain scale (visual analog scale), range of motion, and Shoulder Pain And Disability Index.

Official Title
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Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit to Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

Conditions
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Adhesive Capsulitis of Shoulder

Intervention / Treatment
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* Drug: steroid hydrodilatation
* Drug: axillary nerve injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: age 35-65 years (to prevent the inclusion of patients with secondary AC), onset of shoulder stiffness since over a month limitation in the passive range of motion (ROM) over 30° when compared with the contralateral side in at least two of these three movements: forward flexion, abduction, or external rotation. Exclusion Criteria: ultrasound findings of rotator cuff tears plain radiography findings of significant glenohumeral joint arthritis accompanying cervical radiculopathy systemic inflammatory joint disease intra-articular injection into the glenohumeral joint within the past 3 months history of surgery on the affected shoulders regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids allergy to corticosteroid or lidocaine. -

Ages Eligible for Study
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Minimum Age: 35 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: hydrodilatation and axillary nerve injection<br>patient received ultrasound-guided steroid hydrodilatation via posterior recess | Drug: steroid hydrodilatation<br>* ultrasound-guided steroid hydrodilatation<br>Drug: axillary nerve injection<br>* ultrasound-guided axillary nerve injection<br>|
| Active Comparator: hydrodilatation only<br>patient received ultrasound-guided steroid hydrodilatation only | Drug: steroid hydrodilatation<br>* ultrasound-guided steroid hydrodilatation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Shoulder Pain And disability index | The Shoulder Pain and Disability Index (SPADI) is a self-administered questionnaire that consists of two dimensions, one for pain and the other for functional activities. The pain dimension consists of five questions regarding the severity of an individual's pain. Functional activities are assessed with eight questions designed to measure the degree of difficulty an individual has with various activities of daily living that require upper-extremity use. The SPADI takes 5 to 10 minutes for a patient to complete and is the only reliable and valid region-specific measure for the shoulder.function. The score is divided into four sections: pain, activity of daily living, ROM and strength | Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain intensity | pain intensity was measured by visual analog scale. Each patient was asked to indicate his/her current level of pain by marking a point on a 100-mm VAS, for which 0 represented no pain and 100 represented unbearable pain. | Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline | 
| glenohumeral joint range of motion | change in degrees of shoulder motion | Change at baseline, 6 weeks, 12 weeks |