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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Adhesive Capsulitis of Shoulder
• Intervention / Treatment: Drug: steroid hydrodilatation; Drug: axillary nerve injection

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 Type: Interventional
• Enrollment (Estimated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jia chi C wang; Phone Number: 0919527693; Email: jcwang0726@gmail.com

Study Locations

• Taiwan
  • Taipei City, Taiwan, 241
    • Recruiting
    • Taipei Veterans General Hospital
    • Contact: Jia chi C wang; Phone Number: 0919527693; Email: jcwang0726@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: hydrodilatation and axillary nerve injection; patient received ultrasound-guided steroid hydrodilatation via posterior recess	Drug: steroid hydrodilatation; ultrasound-guided steroid hydrodilatation; Drug: axillary nerve injection; ultrasound-guided axillary nerve injection
Active Comparator: hydrodilatation only; patient received ultrasound-guided steroid hydrodilatation only	Drug: steroid hydrodilatation; ultrasound-guided steroid hydrodilatation

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taipei Veterans General Hospital, Taiwan

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): March 1, 2025
• Study Completion (Estimated): March 1, 2025

Study Registration Dates

• First Submitted: November 22, 2021
• First Submitted That Met QC Criteria: June 16, 2023
• First Posted (Actual): June 27, 2023

Study Record Updates

• Last Update Posted (Actual): June 27, 2023
• Last Update Submitted That Met QC Criteria: June 16, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Joint Diseases; Musculoskeletal Diseases; Bursitis
• Other Study ID Numbers: 2021-02-011B

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No