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

Steroid and Sodium Hyaluronate Hydrodilatation

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05861570
Enrollment
84
Registered
2023-05-17
Start date
2023-05-18
Completion date
2024-04-06
Last updated
2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Adhesive Capsulitis

Brief summary

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

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

Interventions

DRUGnormal saline

Ultrasound guided injection using 3ml normal saline

DRUG(Sodium Hyaluronate (Hyruan One , LG)

Ultrasound guided injection using 3ml of Sodium Hyaluronate

DRUGlidocaine hydrochloride

Ultrasound guided injection using 4ml of 2% lidocaine hydrochloride (Xylocaine)

DRUGTriamcinolone Acetonide

ultrasound guided steroid injection using 4ml of 40mg triamcinolone acetonide

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Masking description

Double (Participant, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
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.

Design outcomes

Primary

MeasureTime frameDescription
change in pain intensity0, 6, 12weekspain intensity was measured by visual analog scale (0-10)

Secondary

MeasureTime frameDescription
change in Shoulder Pain And disability index0, 6, 12 weeksThe 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.
change in glenohumeral joint range of motion0, 6, 12weeksShoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.

Countries

Taiwan

Contacts

Primary ContactJia chi wang
jcwang0726@gmail.com0919527693

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026