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

NCT05921539 | Unknown

• 1 other identifier: 2021-02-011B
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

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.

Conditions

Adhesive Capsulitis of Shoulder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• pain intensity

  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 at baseline, 6 weeks, 12 weeks

Study Arms (2)

hydrodilatation and axillary nerve injection

EXPERIMENTAL

patient received ultrasound-guided steroid hydrodilatation via posterior recess

Drug: steroid hydrodilatation; Drug: axillary nerve injection

hydrodilatation only

ACTIVE COMPARATOR

patient received ultrasound-guided steroid hydrodilatation only

Drug: steroid hydrodilatation

Interventions

steroid hydrodilatation DRUG

ultrasound-guided steroid hydrodilatation

hydrodilatation and axillary nerve injection; hydrodilatation only

axillary nerve injection DRUG

ultrasound-guided axillary nerve injection

hydrodilatation and axillary nerve injection

Eligibility Criteria

• Age: 35 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Taipei Veterans General Hospital, Taiwan: lead

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 241, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Condition Hierarchy (Ancestors)

Joint Diseases; Musculoskeletal Diseases

Central Study Contacts

Jia chi C Wang

CONTACT

0919527693; jcwang0726@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2021
• First Posted: June 27, 2023
• Study Start: December 1, 2021
• Primary Completion: March 1, 2025
• Study Completion: March 1, 2025
• Last Updated: June 27, 2023

Record last verified: 2023-01

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)