Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome
A Short Term Outcomes of Subacromial Injection of Combined Corticosteroid With Low Volume Compared to High Volume of Local Anesthetic for Rotator Cuff Impingement Syndrome: A Randomized Controlled Trials
1 other identifier
interventional
52
0 countries
N/A
Brief Summary
This study aims to assess and compare the effectiveness of two different volumes of local anesthetic combined with 40mg of triamcinolone for subacromial injections in treating patients with rotator cuff impingement syndrome
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started Jan 2015
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 1, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2016
CompletedFirst Submitted
Initial submission to the registry
April 16, 2017
CompletedFirst Posted
Study publicly available on registry
April 19, 2017
CompletedOctober 18, 2017
October 1, 2017
1.6 years
April 16, 2017
October 17, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
VAS
Visual analog score
8 weeks
Secondary Outcomes (2)
WORC
8 weeks
Adverse reaction
8 weeks
Study Arms (2)
Lidocaine 3 cc & Triamcinolone Acetonide
EXPERIMENTALLidocaine 9cc & Triamcinolone Acetonide
ACTIVE COMPARATORInterventions
9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide
Eligibility Criteria
You may qualify if:
- participants with clinically diagnosed the rotator cuff impingement
- participants aged 20 years and older
- at least 1 month's duration
- pain of moderate to severe intensity, defined as a score of 5 or more points on a 10-cm visual analog scale (VAS) rated from 0 (no pain) to 10 (worst imaginable pain)
You may not qualify if:
- patients with adhesive capsulitis of the shoulder (normal radiograph of affected shoulder, and restriction of passive motion \>30° in ≥2 planes of movement)
- previous trauma history at currently affected shoulder
- previous corticosteroid injection history at the affected shoulder
- abnormal calcification and/or primary osteoarthritis of the shoulder joint on plain radiographs
- use of medication such as antiplatelet agent or anticoagulation.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Ramathibodi Hospitallead
- Khon Kaen Universitycollaborator
Related Publications (1)
Boonard M, Sumanont S, Arirachakaran A, Apiwatanakul P, Boonrod A, Kanchanatawan W, Kongtharvonskul J. Short-term outcomes of subacromial injection of combined corticosteroid with low-volume compared to high-volume local anesthetic for rotator cuff impingement syndrome: a randomized controlled non-inferiority trial. Eur J Orthop Surg Traumatol. 2018 Aug;28(6):1079-1087. doi: 10.1007/s00590-018-2149-3. Epub 2018 Feb 8.
PMID: 29423865DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
April 16, 2017
First Posted
April 19, 2017
Study Start
January 1, 2015
Primary Completion
August 1, 2016
Study Completion
August 1, 2016
Last Updated
October 18, 2017
Record last verified: 2017-10