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Comparing Two Methods of Subacromial Space Injection

Primary Purpose

Subacromial Impingement Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Subacromial Injection
Sponsored by
Aneurin Bevan University Health Board
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Subacromial Impingement Syndrome

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Aneurin Bevan University Health BoardRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Anterior portal

Lateral portal

Arm Description

Injection in to subacromial space from anterior portal

Injection in to subacromial space from lateral portal

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Pain control after subacromial injection
The participants will fill a visual analog score before and after injection to assess the pain relief after injection.

Full Information

First Posted
September 3, 2018
Last Updated
September 28, 2018
Sponsor
Aneurin Bevan University Health Board
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1. Study Identification

Unique Protocol Identification Number
NCT03692091
Brief Title
Comparing Two Methods of Subacromial Space Injection
Official Title
Comparing Two Methods of Subacromial Space Injection - A Randomised Blinded Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 6, 2017 (Actual)
Primary Completion Date
February 20, 2019 (Anticipated)
Study Completion Date
February 20, 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Aneurin Bevan University Health Board

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subacromial Impingement Syndrome

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Anterior portal
Arm Type
Active Comparator
Arm Description
Injection in to subacromial space from anterior portal
Arm Title
Lateral portal
Arm Type
Active Comparator
Arm Description
Injection in to subacromial space from lateral portal
Intervention Type
Procedure
Intervention Name(s)
Subacromial Injection
Intervention Description
Injection in to subacromial space in the shoulder from anterior portal
Primary Outcome Measure Information:
Title
The spread of dye in subacromial space
Description
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.
Time Frame
With in One hour
Secondary Outcome Measure Information:
Title
Pain control after subacromial injection
Description
The participants will fill a visual analog score before and after injection to assess the pain relief after injection.
Time Frame
With in One hour

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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.
Facility Information:
Facility Name
Aneurin Bevan University Health Board
City
Newport
ZIP/Postal Code
NP202UB
Country
United Kingdom
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alison Davey
Phone
01633234768
Email
alison.davey@wales.nhs.uk
First Name & Middle Initial & Last Name & Degree
Vasantha kumar Ramsingh, FRCS

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
9059143
Citation
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.
Results Reference
background
PubMed Identifier
10627426
Citation
Calis 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.
Results Reference
background
PubMed Identifier
12368787
Citation
Yamakado 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.
Results Reference
result
PubMed Identifier
9593094
Citation
Partington 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.
Results Reference
result

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Comparing Two Methods of Subacromial Space Injection

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