Comparing Two Methods of Subacromial Space Injection

Subacromial Impingement Syndrome Clinical Trial

Official title:

Comparing Two Methods of Subacromial Space Injection - A Randomised Blinded Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03692091
• Other study ID #: IRAS194489
• Status: Recruiting
• Phase: N/A
• Start date: December 6, 2017
• Est. completion date: February 20, 2019

Study information

• Verified date: September 2018
• Source: Aneurin Bevan University Health Board
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: February 20, 2019
• Est. primary completion date: February 20, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Shoulder Impingement Syndrome
• Subacromial Impingement Syndrome

Intervention

Procedure:
• Subacromial Injection
Injection in to subacromial space in the shoulder from anterior portal

Locations

Country	Name	City	State
United Kingdom	Aneurin Bevan University Health Board	Newport

Sponsors (1)

Lead Sponsor	Collaborator
Aneurin Bevan University Health Board

Country where clinical trial is conducted

United Kingdom, 

References & Publications (4)

Calis M, Akgün K, Birtane M, Karacan I, Calis H, Tüzün F. Diagnostic values of clinical diagnostic tests in subacromial impingement syndrome. Ann Rheum Dis. 2000 Jan;59(1):44-7. — View 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. — View 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. — View Citation

Yamakado K. The targeting accuracy of subacromial injection to the shoulder: an arthrographic evaluation. Arthroscopy. 2002 Oct;18(8):887-91. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Pain control after subacromial injection	The participants will fill a visual analog score before and after injection to assess the pain relief after injection.	With in One hour