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

NCT ID: NCT05921539

Last Updated: 2023-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 72 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-12-01
• Study Completion Date: 2025-03-01

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.

Conditions

Adhesive Capsulitis of Shoulder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

hydrodilatation and axillary nerve injection

patient received ultrasound-guided steroid hydrodilatation via posterior recess

Group Type: EXPERIMENTAL

steroid hydrodilatation

Intervention Type: DRUG

ultrasound-guided steroid hydrodilatation

axillary nerve injection

Intervention Type: DRUG

ultrasound-guided axillary nerve injection

hydrodilatation only

patient received ultrasound-guided steroid hydrodilatation only

Group Type: ACTIVE_COMPARATOR

steroid hydrodilatation

Intervention Type: DRUG

ultrasound-guided steroid hydrodilatation

Interventions

steroid hydrodilatation

ultrasound-guided steroid hydrodilatation

Intervention Type: DRUG

axillary nerve injection

ultrasound-guided axillary nerve injection

Intervention Type: DRUG

Eligibility Criteria

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. -

• Minimum Eligible Age: 35 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Taipei Veterans General Hospital, Taiwan

OTHER_GOV

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Taipei Veterans General Hospital

Taipei, , Taiwan

Site Status: RECRUITING

Countries

Taiwan

Central Contacts

Jia chi C Wang

Role: CONTACT

jcwang0726@gmail.com

0919527693

Facility Contacts

Jia chi C wang

Role: primary

jcwang0726@gmail.com

0919527693

Other Identifiers

2021-02-011B

Identifier Type: -

Identifier Source: org_study_id