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Comparing Two Methods of Subacromial Space Injection

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ClinicalTrials.gov Identifier: NCT03692091
Recruitment Status : Recruiting
First Posted : October 2, 2018
Last Update Posted : October 2, 2018
Sponsor:
Information provided by (Responsible Party):
Vasantha Kumar Ramsingh, Aneurin Bevan University Health Board

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.

Condition or disease Intervention/treatment Phase
Subacromial Impingement Syndrome Procedure: Subacromial Injection Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Comparing Two Methods of Subacromial Space Injection - A Randomised Blinded Trial
Actual Study Start Date : December 6, 2017
Estimated Primary Completion Date : February 20, 2019
Estimated Study Completion Date : February 20, 2019

Arm Intervention/treatment
Active Comparator: Anterior portal
Injection in to subacromial space from anterior portal
Procedure: Subacromial Injection
Injection in to subacromial space in the shoulder from anterior portal

Active Comparator: Lateral portal
Injection in to subacromial space from lateral portal
Procedure: Subacromial Injection
Injection in to subacromial space in the shoulder from anterior portal




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Pain control after subacromial injection [ Time Frame: With in One hour ]
    The participants will fill a visual analog score before and after injection to assess the pain relief after injection.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03692091


Locations
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United Kingdom
Aneurin Bevan University Health Board Recruiting
Newport, United Kingdom, NP202UB
Contact: Alison Davey    01633234768    alison.davey@wales.nhs.uk   
Principal Investigator: Vasantha kumar Ramsingh, FRCS         
Sponsors and Collaborators
Aneurin Bevan University Health Board

Publications of Results:
Other Publications:
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Responsible Party: Vasantha Kumar Ramsingh, Locum Consultant Orthopaedic Surgeon, Aneurin Bevan University Health Board
ClinicalTrials.gov Identifier: NCT03692091     History of Changes
Other Study ID Numbers: IRAS194489
First Posted: October 2, 2018    Key Record Dates
Last Update Posted: October 2, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Shoulder Impingement Syndrome
Joint Diseases
Musculoskeletal Diseases
Shoulder Injuries
Wounds and Injuries