Comparing Two Methods of Subacromial Space Injection

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

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.

Study Overview

• Status: Unknown
• Conditions: Subacromial Impingement Syndrome
• Intervention / Treatment: Procedure: Subacromial Injection

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: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • Newport, United Kingdom, NP202UB
    • Recruiting
    • Aneurin Bevan University Health Board
    • Contact: Alison Davey; Phone Number: 01633234768; Email: alison.davey@wales.nhs.uk
    • Principal Investigator: Vasantha kumar Ramsingh, FRCS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Aneurin Bevan University Health Board

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 6, 2017
• Primary Completion (Anticipated): February 20, 2019
• Study Completion (Anticipated): February 20, 2019

Study Registration Dates

• First Submitted: September 3, 2018
• First Submitted That Met QC Criteria: September 28, 2018
• First Posted (Actual): October 2, 2018

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 28, 2018
• Last Verified: September 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Wounds and Injuries; Joint Diseases; Musculoskeletal Diseases; Shoulder Injuries; Shoulder Impingement Syndrome
• Other Study ID Numbers: IRAS194489

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No