NCT Number: NCT03120923
Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome
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
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Notify MeKey information
Conditions
Age range
20 year and older
Sex eligibility
All sexes
Study type
Interventional
Phase
Phase 4
About this study
Patients with rotator cuff impingement syndrome were randomized to undergo subacromial injection with 10mL total volume of 1% lidocaine plus 40mg triamcinolone acetonide (n = 22), or a 4mL total volume of 1% lidocaine plus 40-mg triamcinolone acetonide (n = 23). Evaluations using a visual analog scale (VAS) for pain during motion, and the Western Ontario Rotator Cuff Index (WORC) were completed before treatment and 30 minutes, 2 weeks, and 8 weeks after injection.
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
- 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)
Exclusion criteria
- 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.
Treatment and study plan
Lidocaine 9 cc
Drug9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide
Triamcinolone Acetonide
DrugPrimary outcomes
-
VAS
Time frame: 8 weeks
Visual analog score
Secondary outcomes
-
WORC
Time frame: 8 weeks
Western Ontario Rotator Cuff Index
-
Adverse reaction
Time frame: 8 weeks
Sponsors and collaborators
Lead sponsor
Ramathibodi Hospital
Other
Collaborators
- Khon Kaen University
Registry information
Official study title
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
Important dates
- Study start
- 2015
- Primary completion
- 2016
- Study completion
- 2016
- First posted
- Apr 19, 2017
- Registry last updated
- Oct 18, 2017
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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