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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05818111
Enrollment
86
Registered
2023-04-18
Start date
2023-01-31
Completion date
2024-02-01
Last updated
2023-04-18

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

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis

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

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

Interventions

DRUGXylocaine 2 % Injectable Solution

xylocaine 2% 4cc

DRUGNormal saline 2cc

normal saline 2cc

DRUGnormal saline 12cc

normal saline 12cc

DRUGsteroid

triamcinolone 40mg 4cc

Sponsors

Taipei Veterans General Hospital, Taiwan
Lead SponsorOTHER_GOV

Study design

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

Eligibility

Sex/Gender
ALL
Age
35 Years to 65 Years
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 8) allergy to corticosteroid or lidocaine.

Design outcomes

Primary

MeasureTime frameDescription
change in visual analog scale visual analog scaleat 6, 12 wkvisual analog scale

Secondary

MeasureTime frameDescription
change in glenohumeral joint range of motionat 6, 12 wkShoulder flexion, abduction, external rotation and internal rotation were measured with goniometer with patient in supine position.
change in Shoulder Pain And disability indexat 6, 12 wkThe 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 pain intensityat 6, 12 wkpain intensity was measured by visual analog scale.

Countries

Taiwan

Contacts

Primary ContactJia chi C Wang
jcwang0726@gmail.com0919527693

Outcome results

None listed

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