Comparing Two Methods of Subacromial Space Injection
1 other identifier
interventional
100
1 country
1
Brief Summary
Subacromial shoulder injections can be approached from the front or side of the shoulder. The investigators are comparing both methods, to find which one has better spread in the subacromial space.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Dec 2017
1 active site
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
December 6, 2017
CompletedFirst Submitted
Initial submission to the registry
September 3, 2018
CompletedFirst Posted
Study publicly available on registry
October 2, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 20, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
February 20, 2019
CompletedOctober 2, 2018
September 1, 2018
1.2 years
September 3, 2018
September 28, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
The spread of dye in subacromial space
The participants will go for an X ray following injection which contains a radio-opaque dye to demonstrate the spread of injected material (Local anaesthetic, depomedrone and Niopam dye) in the subacromial space. A blinded radiologist will read the radiographs and scale the distribution of dye from 1 to 4 depending on the location of radiopaque dye.
With in One hour
Secondary Outcomes (1)
Pain control after subacromial injection
With in One hour
Study Arms (2)
Anterior portal
ACTIVE COMPARATORInjection in to subacromial space from anterior portal
Lateral portal
ACTIVE COMPARATORInjection in to subacromial space from lateral portal
Interventions
Injection in to subacromial space in the shoulder from anterior portal
Eligibility Criteria
You may qualify if:
- Shoulder pain for at least 6 weeks duration along the lateral aspect of the shoulder.
- Positive impingement signs.
You may not qualify if:
- History of compensation claim due to shoulder problems.
- Allergy to radiographic dye.
- Recent shoulder fracture.
- Bleeding disorder.
- Previous shoulder surgery.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Aneurin Bevan University Health Board
Newport, NP202UB, United Kingdom
Related Publications (4)
Eustace JA, Brophy DP, Gibney RP, Bresnihan B, FitzGerald O. Comparison of the accuracy of steroid placement with clinical outcome in patients with shoulder symptoms. Ann Rheum Dis. 1997 Jan;56(1):59-63. doi: 10.1136/ard.56.1.59.
PMID: 9059143BACKGROUNDCalis M, Akgun K, Birtane M, Karacan I, Calis H, Tuzun F. Diagnostic values of clinical diagnostic tests in subacromial impingement syndrome. Ann Rheum Dis. 2000 Jan;59(1):44-7. doi: 10.1136/ard.59.1.44.
PMID: 10627426BACKGROUNDYamakado K. The targeting accuracy of subacromial injection to the shoulder: an arthrographic evaluation. Arthroscopy. 2002 Oct;18(8):887-91. doi: 10.1053/jars.2002.35263.
PMID: 12368787RESULTPartington PF, Broome GH. Diagnostic injection around the shoulder: hit and miss? A cadaveric study of injection accuracy. J Shoulder Elbow Surg. 1998 Mar-Apr;7(2):147-50. doi: 10.1016/s1058-2746(98)90226-9.
PMID: 9593094RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Locum Consultant Orthopaedic Surgeon
Study Record Dates
First Submitted
September 3, 2018
First Posted
October 2, 2018
Study Start
December 6, 2017
Primary Completion
February 20, 2019
Study Completion
February 20, 2019
Last Updated
October 2, 2018
Record last verified: 2018-09