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

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05921539
• Collaborator: (none)
• Enrollment: 72
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 39
• Patients Per Site Per Month: 1.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Adhesive Capsulitis of Shoulder	Drug: steroid hydrodilatation; Drug: axillary nerve injection	N/A

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 Design

• Study Type: Interventional
• Anticipated Enrollment: 72 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Does Axillary Nerve and Inferior Capsule Release Add Extra Benefit to Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
• Actual Study Start Date: Dec 1, 2021
• Anticipated Primary Completion Date: Mar 1, 2025
• Anticipated Study Completion Date: Mar 1, 2025

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. 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

1. 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.

2. glenohumeral joint range of motion [Change at baseline, 6 weeks, 12 weeks]

   change in degrees of shoulder motion

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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. -

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei City		Taiwan	241

Sponsors and Collaborators

• Taipei Veterans General Hospital, Taiwan

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Taipei Veterans General Hospital, Taiwan
• ClinicalTrials.gov Identifier: NCT05921539
• Other Study ID Numbers: 2021-02-011B
• First Posted: Jun 27, 2023
• Last Update Posted: Jun 27, 2023
• Last Verified: Jan 1, 2023

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bursitis

Study Results

No Results Posted as of Jun 27, 2023