Is Combined Steroid and Sodium Hyaluronate Hydrodilatation More Effective Than Isolated Steroid Hydrodilatation in Treating Patients With Adhesive Capsulitis

• Sponsor: Taipei Veterans General Hospital, Taiwan (Other)
• Overall Status: Not yet recruiting
• CT.gov ID: NCT05861570
• Collaborator: (none)
• Enrollment: 84
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 10.3
• Patients Per Site Per Month: 8.2

Study Details

Study Description

Brief Summary

This study was conducted to compare the efficacy of hydrodilatation with steroid with hyaluronic acid and steroid for treating adhesive capsulitis.

Condition or Disease	Intervention/Treatment	Phase
Adhesive Capsulitis	Drug: normal saline; Drug: (Sodium Hyaluronate (Hyruan One , LG); Drug: lidocaine hydrochloride; Drug: Triamcinolone Acetonide	N/A

Detailed Description

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 (hydrodilatation with steroid ) and group 2 (hydrodilatation with hyaluronic acid and steroid). 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: 84 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Outcomes Assessor)
• Masking Description: Double (Participant, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Steroid and Sodium Hyaluronate Hydrodilatation
• Anticipated Study Start Date: May 30, 2023
• Anticipated Primary Completion Date: Apr 6, 2024
• Anticipated Study Completion Date: Apr 6, 2024

Arms and Interventions

Arm	Intervention/Treatment
Experimental: hydrodilatation with steroid patient received ultrasound-guided 3cc NS + 40mg triamcinolone + 4cc xylocaine	Drug: normal saline; Ultrasound guided injection using 3ml normal saline; Drug: lidocaine hydrochloride; Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine); Drug: Triamcinolone Acetonide; ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide
Active Comparator: hydrodilatation with hyaluronic acid and steroid patient received ultrasound-guided 3cc hyaluronic acid + 40mg triamcinolone + 4cc xylocaine	Drug: (Sodium Hyaluronate (Hyruan One , LG); Ultrasound guided injection using 3ml of Sodium Hyaluronate; Drug: lidocaine hydrochloride; Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine); Drug: Triamcinolone Acetonide; ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide

Outcome Measures

Primary Outcome Measures

1. change in pain intensity [0, 6, 12weeks]

   pain intensity was measured by visual analog scale (0-10)

Secondary Outcome Measures

1. change in Shoulder Pain And disability index [0, 6, 12 weeks]

   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.

2. change in glenohumeral joint range of motion [0, 6, 12weeks]

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

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

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. 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,

8. 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: NCT05861570
• Other Study ID Numbers: 2022-01-001B
• First Posted: May 17, 2023
• Last Update Posted: May 17, 2023
• Last Verified: Apr 1, 2023

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Bursitis; Triamcinolone; Triamcinolone Acetonide; Triamcinolone hexacetonide; Lidocaine; Hyaluronic Acid; Triamcinolone diacetate

Study Results

No Results Posted as of May 17, 2023