NCT05818111

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
86

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Jan 2023

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 31, 2023

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 5, 2023

Completed
13 days until next milestone

First Posted

Study publicly available on registry

April 18, 2023

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 31, 2024

Completed
1 day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

April 18, 2023

Status Verified

December 1, 2022

Enrollment Period

1 year

First QC Date

April 5, 2023

Last Update Submit

April 5, 2023

Conditions

Adhesive Capsulitis

Keywords

adhesive capsulitis

Outcome Measures

Primary Outcomes (1)

  • change in visual analog scale visual analog scale

    visual analog scale

    at 6, 12 wk

Secondary Outcomes (3)

  • change in glenohumeral joint range of motion

    at 6, 12 wk

  • change in Shoulder Pain And disability index

    at 6, 12 wk

  • change in pain intensity

    at 6, 12 wk

Study Arms (2)

low volume hydrodilatation

EXPERIMENTAL

patient received ultrasound-guided low volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +2cc normal saline)

Drug: steroidDrug: Xylocaine 2 % Injectable SolutionDrug: Normal saline 2cc

high volume hydrodilatation

ACTIVE COMPARATOR

patient received ultrasound-guided high volume steroid hydrodilatation (4cc shincort + 4cc 2% xylocaine +12cc normal saline)

Drug: steroidDrug: Xylocaine 2 % Injectable SolutionDrug: normal saline 12cc

Interventions

steroidDRUG

triamcinolone 40mg 4cc

high volume hydrodilatationlow volume hydrodilatation
Xylocaine 2 % Injectable SolutionDRUG

xylocaine 2% 4cc

high volume hydrodilatationlow volume hydrodilatation
Normal saline 2ccDRUG

normal saline 2cc

low volume hydrodilatation
normal saline 12ccDRUG

normal saline 12cc

high volume hydrodilatation

Eligibility Criteria

Age35 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Taipei Veterans General Hospital

Taipei, 11217, Taiwan

RECRUITING

MeSH Terms

Conditions

Bursitis

Interventions

SteroidsLidocaine

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Fused-Ring CompoundsPolycyclic CompoundsAcetanilidesAnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Central Study Contacts

Jia chi C Wang

CONTACT

0919527693jcwang0726@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER GOV
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 5, 2023

First Posted

April 18, 2023

Study Start

January 31, 2023

Primary Completion

January 31, 2024

Study Completion

February 1, 2024

Last Updated

April 18, 2023

Record last verified: 2022-12

Locations

TW(1)