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

Not Applicable

Recruiting

• Conditions: Adhesive Capsulitis of Shoulder
• Interventions: Drug: steroid hydrodilatation; Drug: axillary nerve injection

• Registration Number: NCT05921539
• Lead Sponsor: Taipei Veterans General Hospital, Taiwan

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2021-11-22
• Study Start: 2021-12-01
• Status Verified: 2023-01
• Study First Submitted QC: 2023-06-16
• Last Update Submitted: 2023-06-16
• Study First Posted: 2023-06-27
• Last Update Posted: 2023-06-27
• Primary Completion: 2025-03-01
• Study Completion: 2025-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 72

Inclusion Criteria

1. age 35-65 years (to prevent the inclusion of patients with secondary AC),
2. onset of shoulder stiffness since over a month
3. 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

1. ultrasound findings of rotator cuff tears
2. plain radiography findings of significant glenohumeral joint arthritis
3. accompanying cervical radiculopathy
4. systemic inflammatory joint disease
5. intra-articular injection into the glenohumeral joint within the past 3 months
6. history of surgery on the affected shoulders
7. regular use of systemic non-steroidal anti-inflammatory drugs or corticosteroids
8. allergy to corticosteroid or lidocaine. -

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
hydrodilatation only	steroid hydrodilatation	patient received ultrasound-guided steroid hydrodilatation only
hydrodilatation and axillary nerve injection	steroid hydrodilatation	patient received ultrasound-guided steroid hydrodilatation via posterior recess
hydrodilatation and axillary nerve injection	axillary nerve injection	patient received ultrasound-guided steroid hydrodilatation via posterior recess

Primary Outcome Measures

Name	Time	Method
Shoulder Pain And disability index	Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline	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

Secondary Outcome Measures

Name	Time	Method
pain intensity	Change of the score between 6 weeks and baseline, and change of the score between 12 weeks and baseline	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.
glenohumeral joint range of motion	Change at baseline, 6 weeks, 12 weeks	change in degrees of shoulder motion

Trial Locations

Locations (1)

Taipei Veterans General Hospital; 🇨🇳 Taipei City, Taiwan