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

Adhesive Capsulitis of Shoulder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05921539
• Other study ID #: 2021-02-011B
• Status: Recruiting
• Phase: N/A
• Start date: December 1, 2021
• Est. completion date: March 1, 2025

Study information

• Verified date: January 2023
• Source: Taipei Veterans General Hospital, Taiwan
• Contact: Jia chi C Wang
• Phone: 0919527693
• Email: jcwang0726[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: March 1, 2025
• Est. primary completion date: March 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 35 Years to 65 Years

Eligibility

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. -

Related Conditions & MeSH terms

• Adhesive Capsulitis of Shoulder
• Bursitis

Intervention

Drug:
• steroid hydrodilatation
ultrasound-guided steroid hydrodilatation
• axillary nerve injection
ultrasound-guided axillary nerve injection

Locations

Country	Name	City	State
Taiwan	Taipei Veterans General Hospital	Taipei City

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Veterans General Hospital, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	glenohumeral joint range of motion	change in degrees of shoulder motion	Change at baseline, 6 weeks, 12 weeks