Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05818111
• Collaborator: (none)
• Enrollment: 86
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 12
• Patients Per Site Per Month: 7.2

Study Details

Study Description

Brief Summary

This study was conducted to compare the efficacy of low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis

Condition or Disease	Intervention/Treatment	Phase
Adhesive Capsulitis	Drug: steroid; Drug: Xylocaine 2 % Injectable Solution; Drug: Normal saline 2cc; Drug: normal saline 12cc	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 low volume steroid hydrodilatation with high volume steroid hydrodilatation under ultrasonographic guidance for treating adhesive capsulitis Design: a prospective, double-blinded, randomized, clinical trial

Patient and methods:

Patients with adhesive capsulitis for at least 3 months were enrolled and randomly allocated into group 1 (10cc steroid hydrodilatation under ultrasonographic guidance ) and group 2 (20cc steroid hydrodilatation). 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, Shoulder Pain And Disability Index

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 86 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Comparison of Different Volume of Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis
• Actual Study Start Date: Jan 31, 2023
• Anticipated Primary Completion Date: Jan 31, 2024
• Anticipated Study Completion Date: Feb 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: low volume hydrodilatation patient received ultrasound-guided low volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +2cc normal saline)	Drug: steroid; triamcinolone 40mg 4cc; Drug: Xylocaine 2 % Injectable Solution; xylocaine 2% 4cc; Drug: Normal saline 2cc; normal saline 2cc
Active Comparator: high volume hydrodilatation patient received ultrasound-guided high volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +12cc normal saline)	Drug: steroid; triamcinolone 40mg 4cc; Drug: Xylocaine 2 % Injectable Solution; xylocaine 2% 4cc; Drug: normal saline 12cc; normal saline 12cc

Outcome Measures

Primary Outcome Measures

1. change in visual analog scale visual analog scale [at 6, 12 wk]

   visual analog scale

Secondary Outcome Measures

1. change in glenohumeral joint range of motion [at 6, 12 wk]

   Shoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.

2. change in Shoulder Pain And disability index [at 6, 12 wk]

   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.

3. change in pain intensity [at 6, 12 wk]

   pain intensity was measured by visual analog scale.

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, and 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) intraarticular 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, and

1. allergy to corticosteroid or lidocaine.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Taipei Veterans General Hospital	Taipei City		Taiwan	11217

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: NCT05818111
• Other Study ID Numbers: 2022-12-001B
• First Posted: Apr 18, 2023
• Last Update Posted: Apr 18, 2023
• Last Verified: Dec 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Taipei Veterans General Hospital, Taiwan: adhesive capsulitis
• Additional relevant MeSH terms: Bursitis; Lidocaine

Study Results

No Results Posted as of Apr 18, 2023