Subacromial Impingement SyndromeNSAIDNCT01449448
Subacromial Injection With Corticosteroid Versus Nonsteroidal Anti-inflammatory Drugs (NSAID) in Shoulder Impingement Syndrome
A study testing Ketorolac and Triamcinolone in people with Subacromial Impingement Syndrome and Subacromial Bursitis, run by Madigan Army Medical Center.
Trial summary
Injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Subacromial Impingement Syndrome, Subacromial Bursitis
- What is being tested?
- Ketorolac and Triamcinolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2000to Sep 2005
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign)
- Diagnosis of subacromial bursitis based on tenderness to palpation anterior/lateral to the acromion. Pain may be exacerbated with the shoulder held in internal rotation (positive Hawkins test)
Who cannot join
- Age <18 years
- Symptoms less than one month
- Previous shoulder injections within the past 3 months
- Evidence of os-acromiale or other confounding shoulder pathology on plain radiographs
- Evidence of shoulder osteoarthritis
- Full thickness rotator cuff tear evidenced by MRI, cuff weakness after lidocaine injection, or positive drop-arm sign
Show all 13Show fewer
- Systemic inflammatory condition
- Pending litigation or work-related claims related to the shoulder
- Previous shoulder surgery on the affected shoulder
- Evidence of local infection
- Evidence of adhesive capsulitis
- Previous history of gastrointestinal ulcers or bleeding disorders
- Evidence of shoulder instability
About this study
Official title: A Double-blind Randomized Controlled Trial Comparing the Effects of Subacromial Injection With Corticosteroid Versus NSAID in Patients With Shoulder Impingement Syndrome
Injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. Each patient was randomized into the Steroid group or NSAID group.
Read the detailed description
After a single injection into the subacromial space, the patients were instructed to perform home physical therapy and follow-up in four weeks. Each patient was evaluated in terms of arc of motion, Visual Analog Scale and the UCLA Shoulder Rating Scale.
The outcome measures were taken at the preinjection state, immediately post injection, and at 4 weeks follow-up.
- Being tested
- Ketorolac, Triamcinolone
- Keywords
- pain relief, Hypermobility, Joint, increased strength, increased patient satisfaction
- Medical subject headings
- Shoulder Impingement Syndrome, Joint Instability
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KetorolacDrug
Subacromial injection
TriamcinoloneDrug
Subacromial Injection
| Study group | Role | What they receive |
|---|---|---|
| NSAID | Experimental | Test Group: This group was given subacromial injections of Ketorolac. Receives: Drug: Ketorolac |
| Steroid | Active comparator | This group was given a subacromial injection triamcinolone. Receives: Drug: Triamcinolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
UCLA Shoulder Rating Scale
This scoring system consists of subjective assessments of pain, function and satisfaction, as well as objective measurements of active forward elevation and strength in forward flexion.
Measured: 4 Weeks
Secondary outcomes (2)
Visual Analog Scale
This is a pain scale.
Measured: 4 Weeks
Range of Motion
Shoulder Range of Motion was assessed with a hand held goniometer
Measured: 4 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2011 (estimated)
- Study startSep 2000
- Primary completionSep 2005
- Study completionSep 2005
Why it stopped: PI didn't have time to finish approval process
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Madigan Army Medical Center
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Kyong S Min, MD, Principal investigator, Madigan Army Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01449448
- Sponsor's protocol ID
- impingement
- Acronym
- NSAID
- Status last verified
- Nov 2016
- First submitted
- 6 Oct 2011
- Last updated
- 4 Nov 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22.
PubMed 23177167
Study at a glance
From the registry record, last updated by the sponsor on 4 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Double-blind Randomized Controlled Trial Comparing the Effects of Subacromial Injection With Corticosteroid Versus NSAID in Patients With Shoulder Impingement Syndrome
- ClinicalTrials.gov ID
- NCT01449448
- Acronym / sponsor ID
- NSAID / impingement
- Keywords
- pain relief, Hypermobility, Joint, increased strength, increased patient satisfaction
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: PI didn't have time to finish approval process
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Madigan Army Medical CenterUS federal agency
- Study start
- Sep 2000
- Primary completion
- Sep 2005 (actual)
- Study completion
- Sep 2005 (actual)
- First posted
- 10 Oct 2011 (estimated)
- 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.
Injection with corticosteroid is one of the most common non-operative interventions in the treatment of subacromial impingement; however, its use is limited by its potential side effects (e.g. tendon rupture, subcutaneous atrophy, articular cartilage changes). The objective of this study was to compare the efficacy of subacromial injection of triamcinolone compared to injection of ketorolac. Thirty-two patients diagnosed with external shoulder impingement syndrome were included in this double-blinded randomized controlled clinical trial. Each patient was randomized into the Steroid group or NSAID group.
Detailed description
After a single injection into the subacromial space, the patients were instructed to perform home physical therapy and follow-up in four weeks. Each patient was evaluated in terms of arc of motion, Visual Analog Scale and the UCLA Shoulder Rating Scale.
The outcome measures were taken at the preinjection state, immediately post injection, and at 4 weeks follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NSAID | Experimental | Drug: KetorolacTest Group: This group was given subacromial injections of Ketorolac. |
| Steroid | Active comparator | Drug: TriamcinoloneThis group was given a subacromial injection triamcinolone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Shoulder pain characteristic of subacromial impingement syndrome with passive and/or active abduction in the 60-120 arc of motion (positive impingement sign)
- Diagnosis of subacromial bursitis based on tenderness to palpation anterior/lateral to the acromion. Pain may be exacerbated with the shoulder held in internal rotation (positive Hawkins test)
Key exclusion criteria (13 listed)
- Age <18 years
- Symptoms less than one month
- Previous shoulder injections within the past 3 months
- Evidence of os-acromiale or other confounding shoulder pathology on plain radiographs
- Evidence of shoulder osteoarthritis
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 |
|---|---|---|
| KetorolacSubacromial injection | Drug | NSAID |
| TriamcinoloneSubacromial Injection | Drug | Steroid |
Primary outcome
UCLA Shoulder Rating Scale
Time frame: 4 Weeks
This scoring system consists of subjective assessments of pain, function and satisfaction, as well as objective measurements of active forward elevation and strength in forward flexion.
2 secondary outcomes
Visual Analog Scale
Time frame: 4 Weeks
Range of Motion
Time frame: 4 Weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Nov 2016.
- Derived from this study: PubMed 23177167Min KS, St Pierre P, Ryan PM, Marchant BG, Wilson CJ, Arrington ED. A double-blind randomized controlled trial comparing the effects of subacromial injection with corticosteroid versus NSAID in patients with shoulder impingement syndrome. J Shoulder Elbow Surg. 2013 May;22(5):595-601. doi: 10.1016/j.jse.2012.08.026. Epub 2012 Nov 22.
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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.
Kyong S Min, MD principal investigator
Madigan Army Medical Center
Questions about this trial
What is this clinical trial studying?
A study testing Ketorolac and Triamcinolone in people with Subacromial Impingement Syndrome and Subacromial Bursitis, run by Madigan Army Medical Center.
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 13 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: withdrawn, as of the sponsor's last update on 4 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
UCLA Shoulder Rating Scale (time frame: 4 Weeks). 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 NCT01449448, which also lists 1 linked publication.
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 4 Nov 2016.