Subacromial Impingement SyndromeNCT03692091
Comparing Two Methods of Subacromial Space Injection
A study testing Subacromial Injection in people with Subacromial Impingement Syndrome, run by Aneurin Bevan University Health Board at 1 site in United Kingdom.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome
- What is being tested?
- Subacromial Injection
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Dec 2017to 20 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- Shoulder pain for at least 6 weeks duration along the lateral aspect of the shoulder.
- Positive impingement signs.
Who cannot join
- History of compensation claim due to shoulder problems.
- Allergy to radiographic dye.
- Recent shoulder fracture.
- Bleeding disorder.
- Previous shoulder surgery.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
Aneurin Bevan University Health Board
Newport, NP202UB
Alison Davey, 01633234768, alison.davey@wales.nhs.uk
Vasantha kumar Ramsingh, FRCS
About this study
Official title: 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.
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.
- Conditions
- Subacromial Impingement Syndrome
- Being tested
- Subacromial Injection
- Medical subject headings
- Shoulder Impingement Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Subacromial InjectionProcedure or surgery
Injection in to subacromial space in the shoulder from anterior portal
| Study group | Role | What they receive |
|---|---|---|
| Anterior portal | Active comparator | Injection in to subacromial space from anterior portal Receives: Procedure: Subacromial Injection |
| Lateral portal | Active comparator | Injection in to subacromial space from lateral portal Receives: Procedure: Subacromial Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: With in One hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Oct 2018
- Study start6 Dec 2017
- Primary completion20 Feb 2019 (estimated)
- Study completion20 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Subacromial Impingement SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aneurin Bevan University Health Board
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Vasantha Kumar Ramsingh, Aneurin Bevan University Health Board
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03692091
- Sponsor's protocol ID
- IRAS194489
- Status last verified
- Sep 2018
- First submitted
- 3 Sep 2018
- Last updated
- 2 Oct 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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 9059143Calis 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 10627426Yamakado 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 12368787Partington 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
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing Two Methods of Subacromial Space Injection - A Randomised Blinded Trial
- ClinicalTrials.gov ID
- NCT03692091
- Acronym / sponsor ID
- IRAS194489
- Conditions
- Subacromial Impingement Syndrome
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Aneurin Bevan University Health BoardUniversity, hospital or other
- Study start
- 6 Dec 2017 (actual)
- Primary completion
- 20 Feb 2019 (estimated)
- Study completion
- 20 Feb 2019 (estimated)
- First posted
- 2 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Anterior portal | Active comparator | Procedure: Subacromial InjectionInjection in to subacromial space from anterior portal |
| Lateral portal | Active comparator | Procedure: Subacromial InjectionInjection in to subacromial space from lateral portal |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- Shoulder pain for at least 6 weeks duration along the lateral aspect of the shoulder.
- Positive impingement signs.
Key exclusion criteria (5 listed)
- History of compensation claim due to shoulder problems.
- Allergy to radiographic dye.
- Recent shoulder fracture.
- Bleeding disorder.
- Previous shoulder surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Subacromial InjectionInjection in to subacromial space in the shoulder from anterior portal | Procedure or surgery | Anterior portal, Lateral portal |
Primary outcome
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.
1 secondary outcome
Pain control after subacromial injection
Time frame: With in One hour
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Oct 2018.
- Background: PubMed 9059143Eustace 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.
- Background: PubMed 10627426Calis 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 publication: PubMed 12368787Yamakado 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 publication: PubMed 9593094Partington 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Subacromial Injection in people with Subacromial Impingement Syndrome, run by Aneurin Bevan University Health Board at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The spread of dye in subacromial space (time frame: With in One hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03692091, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Oct 2018.