ClinicalTrials.gg
Status unknownNCT03692091Updated Oct 2, 2018

Comparing Two Methods of Subacromial Space Injection

An interventional study of Subacromial Injection in Subacromial Impingement Syndrome, sponsored by Aneurin Bevan University Health Board. Status unknown at 1 site in United Kingdom. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Aneurin Bevan University Health Board · Not applicable, Interventional, and Diagnostic

The sponsor has not verified this record recently (last verified Sep 2018), so the status shown — last known as Recruiting — may be out of date.

From the registry’s dates

  • Registered 8 months after the study started (first participant enrolled Dec 2017, registered Sep 2018).
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Subacromial Impingement Syndrome
03

In context

Shoulder Impingement Syndrome

320 studies on the registry are indexed under Shoulder Impingement Syndrome; 62 are open to participants now.

This study's planned enrollment of 100 is above the median of 54 across 271 interventional studies indexed under Shoulder Impingement Syndrome.

Browse Shoulder Impingement Syndrome studies →

Lead sponsor

Aneurin Bevan University Health Board is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Shoulder pain for at least 6 weeks duration along the lateral aspect of the shoulder.
  • Positive impingement signs.

Exclusion criteria

Exclusion Criteria:

  • History of compensation claim due to shoulder problems.
  • Allergy to radiographic dye.
  • Recent shoulder fracture.
  • Bleeding disorder.
  • Previous shoulder surgery.
05

Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • Active comparator
    Anterior portal

    Injection in to subacromial space from anterior portal

    Procedure: Subacromial Injection

  • Active comparator
    Lateral portal

    Injection in to subacromial space from lateral portal

    Procedure: Subacromial Injection

Interventions

  • ProcedureSubacromial Injection

    Injection in to subacromial space in the shoulder from anterior portal

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: With in One hour

Secondary outcomes

  1. Pain control after subacromial injection

    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

07

Study locations

1 of 1 sites recruiting
  • Aneurin Bevan University Health Board
    Newport, NP202UB, United Kingdom
    Recruiting
08

References and documents

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. PubMed 9059143 ↗
  • 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. PubMed 10627426 ↗
  • 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. PubMed 12368787 ↗
  • 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. PubMed 9593094 ↗

Individual participant data

Plan to share: Undecided

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Dec 2017 (actual). Primary completion is estimated for Feb 2019, 14 months after the start.

Of 170 non-industry interventional studies with no phase under Shoulder Impingement Syndrome, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 24. This study's planned 14 months is above that.

Counting every sponsor, half of 172 studies reached it within 12 months; a quarter within 5 and three quarters within 24.

How these figures are worked out, and which studies are left out of them.

Registered
Sep 3, 2018
First posted
Oct 2, 2018
StartActual
Dec 6, 2017
Primary completionEst.
Feb 20, 2019
CompletionEst.
Feb 20, 2019
Last update
Oct 2, 2018
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03692091
Lead sponsor
Aneurin Bevan University Health Board
Responsible party
Vasantha Kumar Ramsingh (Locum Consultant Orthopaedic Surgeon, Aneurin Bevan University Health Board) — Principal investigator
First posted
Oct 2, 2018
Start date
Dec 6, 2017
Primary completion
Feb 20, 2019 (estimated)
Completion
Feb 20, 2019 (estimated)
Last update
Oct 2, 2018

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2018. You cannot join it, but the record below documents what was studied.

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