- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03120923
Combined Corticosteroid With Low Volume Compared to High Volume in Impingement Syndrome
October 17, 2017 updated by: Jatupon Kongtharvonskul, Ramathibodi Hospital
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
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
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
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.
Study Type
Interventional
Enrollment (Actual)
52
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Lidocaine 3 cc & Triamcinolone Acetonide
|
|
Active Comparator: Lidocaine 9cc & Triamcinolone Acetonide
|
9mL of 1% lidocaine plus 1mL of 40mg triamcinolone acetonide
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
VAS
Time Frame: 8 weeks
|
Visual analog score
|
8 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
WORC
Time Frame: 8 weeks
|
Western Ontario Rotator Cuff Index
|
8 weeks
|
Adverse reaction
Time Frame: 8 weeks
|
8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2015
Primary Completion (Actual)
August 1, 2016
Study Completion (Actual)
August 1, 2016
Study Registration Dates
First Submitted
April 16, 2017
First Submitted That Met QC Criteria
April 16, 2017
First Posted (Actual)
April 19, 2017
Study Record Updates
Last Update Posted (Actual)
October 18, 2017
Last Update Submitted That Met QC Criteria
October 17, 2017
Last Verified
October 1, 2017
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Arrhythmia Agents
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Sensory System Agents
- Anesthetics
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Membrane Transport Modulators
- Anesthetics, Local
- Voltage-Gated Sodium Channel Blockers
- Sodium Channel Blockers
- Lidocaine
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- HE551338
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Undecided
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Impingement Shoulder
-
CHU de ReimsTerminatedSubacromial Impingement of the ShoulderFrance
-
Copenhagen University Hospital, HvidovreUniversity of Copenhagen; Aalborg University; Metropolitan University CollegeCompletedSubacromial Impingement SyndromeDenmark
-
Faculdade de Ciências Médicas da Santa Casa de...Completed
-
Cairo UniversityNot yet recruitingShoulder ImpingementEgypt
-
Uskudar UniversityCompletedShoulder ImpingementTurkey
-
Universitaire Ziekenhuizen KU LeuvenCompleted
-
Texas Tech University Health Sciences CenterCompletedThe Pull Test To Determine Responders To Subacromial Injection In Patients With Shoulder ImpingementShoulder Impingement SyndromeUnited States
-
National Taiwan University HospitalCompletedShoulder ImpingementTaiwan
-
Romano Orthopaedic CenterCompleted
-
Uskudar State HospitalNot yet recruitingSubacromial Impingement Syndrome | Shoulder Impingement Syndrome | Shoulder Pain | Subacromial Impingement | Shoulder Impingement
Clinical Trials on Triamcinolone Acetonide
-
Weill Medical College of Cornell UniversityCompletedNail Diseases | Nail PsoriasisUnited States
-
Clearside Biomedical, Inc.CompletedPanuveitis | Uveitis | Posterior Uveitis | Intermediate Uveitis | Noninfectious UveitisUnited States
-
Novartis PharmaceuticalsCompletedAcute Gouty Arthritis FlaresUnited States, Estonia, Lithuania, Germany, Russian Federation, Canada, Australia, Latvia, Ukraine
-
University of North Carolina, Chapel HillCompletedHidradenitis SuppurativaUnited States
-
Jaeb Center for Health ResearchNational Eye Institute (NEI); AllerganCompletedDiabetic Macular EdemaUnited States
-
Patel, Rita Vikram, M.D.Ranbaxy Inc.CompletedAcute Steroid Responsive Dermatoses | Chronic Steroid Responsive DermatosesUnited States
-
Shahid Beheshti University of Medical SciencesCompletedDiabetic Macular EdemaIran, Islamic Republic of
-
Clinica Dermatologica Arbache ltdaRecruitingLichen Sclerosus of External Female Genital OrgansBrazil
-
Apotex Inc.Completed
-
SurModics, Inc.CompletedDiabetic Macular EdemaUnited States