Comparing Two Methods of Subacromial Space Injection
Sponsor:
Aneurin Bevan University Health Board
Collaborators:
Information provided by (Responsible Party):
Vasantha Kumar Ramsingh，Aneurin Bevan University Health Board
| Tracking Information | |||
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| First Submitted Date ICMJE | September 3, 2018 | ||
| First Posted Date ICMJE | October 2, 2018 | ||
| Last Update Posted Date | October 2, 2018 | ||
| Actual Study Start Date ICMJE | December 6, 2017 | ||
| Estimated Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | ||
| Current Primary Outcome Measures ICMJE |
The spread of dye in subacromial space[ Time Frame: With in One hour ] 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. |
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| Original Primary Outcome Measures ICMJE | Same as current | ||
| Current Secondary Outcome Measures ICMJE |
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| Descriptive Information | |||
| Brief Title ICMJE | Comparing Two Methods of Subacromial Space Injection |
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| Official Title ICMJE | Comparing Two Methods of Subacromial Space Injection - A Randomised Blinded Trial |
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| 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. |
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| Detailed Description | Both lateral and posterio-lateral methods of subacromial injections are widely used for diagnostic and therapeutic purposes. It is not known which method allows the most accurate access into the subacromial space and is more effective. The investigators have been using a novel approach from the anterior aspect of the shoulder for years with good clinical effect and propose comparing this approach to the described approach. This study will indicate which method is best and will be of practical clinical importance. The investigators feel the technique is easier to perform than other described methods and could be taught to clinicians throughout the country and adopted as the standard approach. | ||
| Study Type ICMJE | Interventional | ||
| Study Phase | N/A | ||
| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Masking: Interventional Masking Description: Primary Purpose: Diagnostic |
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| Condition ICMJE | |||
| Intervention ICMJE |
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| Study Arms |
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| Recruitment Information | |||
| Recruitment Status ICMJE | Recruiting | ||
| Estimated Enrollment ICMJE |
100 | ||
| Original Estimated Enrollment ICMJE | Same as current | ||
| Estimated Study Completion Date | February 20, 2019 | ||
| Estimated Primary Completion Date | February 20, 2019 (Final data collection date for primary outcome measure) | ||
| Eligibility Criteria ICMJE | Inclusion Criteria: - Shoulder pain for at least 6 weeks duration along the lateral aspect of the shoulder. - Positive impingement signs. Exclusion Criteria: - History of compensation claim due to shoulder problems. - Allergy to radiographic dye. - Recent shoulder fracture. - Bleeding disorder. - Previous shoulder surgery. | ||
| Sex/Gender |
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| Ages | N/A and older (Adult, Older Adult) | ||
| Accepts Healthy Volunteers | No | ||
| Listed Location Countries ICMJE | United Kingdom | ||
| Removed Location Countries | |||
| Administrative Information | Has Data Monitoring Committee | ||
| U.S. FDA-regulated Product |
Studies a U.S. FDA-regulated Drug Product: No Studies a U.S. FDA-regulated Device Product: No |
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| IPD Sharing Statement |
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| Responsible Party | Vasantha Kumar Ramsingh，Aneurin Bevan University Health Board | ||
| Study Sponsor ICMJE | Aneurin Bevan University Health Board | ||
| Collaborators ICMJE | |||
| Investigators ICMJE |
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| PRS Account | Aneurin Bevan University Health Board | ||
| Verification Date | September 2018 | ||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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