Subacromial ImpingementPhase 2NCT03913702
Subacromial Methylprednisolone Versus Ketorolac for Shoulder Impingement
A Phase 2 study testing Ketorolac Tromethamine and Methylprednisolone Acetate in people with Subacromial Impingement and Subacromial Impingement Syndrome, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
Trial summary
The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome. Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Subacromial Impingement, Subacromial Impingement Syndrome
- What is being tested?
- Ketorolac Tromethamine and Methylprednisolone Acetate
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Sep 2019to 2 Nov 2022
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >18 years
- Severe or recalcitrant shoulder impingement syndrome
- Subacromial injection is a therapeutic option
Who cannot join
- Allergy or intolerance to steroids within less than 1 month
- Allergy or intolerance to NSAIDs within less than 1 month
- Pregnancy
- Breastfeeding
- Pre-existing asthma
- Uncontrolled psychiatric illness
Show all 21Show fewer
- Previous shoulder injection within the past 3 months
- Evidence of confounding shoulder pathology on imaging
- History of a full-thickness rotator cuff tear
- Ipsilateral cervical radiculopathy
- Moderate to severe glenohumeral arthritis
- Systemic inflammatory conditions
- Kidney disease
- Liver disease
- Gastrointestinal ulcer
- Bleeding disorder
- 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
- Evidence of shoulder instability
Trial locations and contacts
1 site in 1 country.
United States1 site
Universtiy of Texas Medical Branch
Galveston, Texas, 77555
About this study
Official title: Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.
Read the detailed description
Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.
- Being tested
- Ketorolac Tromethamine, Methylprednisolone Acetate
- Keywords
- Ketorolac, Methylprednisolone, Subacromial impingement syndrome
- 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.
Ketorolac TromethamineDrug
Also called Toradol
2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml).
Methylprednisolone AcetateDrug
Also called DepoMedrol
1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml)
| Study group | Role | What they receive |
|---|---|---|
| Ketorolac | Active comparator | Assigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%) Receives: Drug: Ketorolac Tromethamine |
| Methylprednisolone | Active comparator | Assigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%) Receives: Drug: Methylprednisolone Acetate |
What is being measured
The primary outcome is the main question the study is designed to answer.
American Shoulder and Elbow Surgeon (ASES)
The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Measured: 12 weeks
Secondary outcomes (3)
American Shoulder and Elbow Surgeon (ASES)
The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Measured: 2 weeks
American Shoulder and Elbow Surgeon (ASES)
The ASES is a self-assessment score, ranging between 0 and 100, (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
Measured: 4 weeks
Range of Motion (ROM)
The range of motion is a function-related measure, that reflects the extent of shoulder movement (measured in degrees, in forward flexion, and abduction with internal/external rotation of the shoulder)
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2019
- Study start9 Sep 2019
- Primary completion2 Nov 2022
- Study completion2 Nov 2022
Why it stopped: Inadequate patient enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Subacromial ImpingementStudies of the same condition, open and under way.
- More trials run by The University of Texas Medical Branch, GalvestonThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeremy Somerson, MD, Principal investigator, University of Texas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03913702
- Sponsor's protocol ID
- UTMB IRB #: 18-0156
- Status last verified
- Dec 2024
- First submitted
- 10 Apr 2019
- Last updated
- 3 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: At the end of this investigation, IPD-related results will be tabulated and submitted to clinicaltrials.gov to report. This would help evaluate the effects and safety of interventions administered.
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Subacromial Injection of Methylprednisolone Versus Ketorolac to Treat Shoulder Impingement: a Double-blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03913702
- Acronym / sponsor ID
- UTMB IRB #: 18-0156
- Keywords
- Ketorolac, Methylprednisolone, Subacromial impingement syndrome
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Inadequate patient enrollment
- Enrolment
- 1 participants (actual)
- Lead sponsor
- The University of Texas Medical Branch, GalvestonUniversity, hospital or other
- Study start
- 9 Sep 2019 (actual)
- Primary completion
- 2 Nov 2022 (actual)
- Study completion
- 2 Nov 2022 (actual)
- First posted
- 12 Apr 2019 (actual)
- Results
- Posted 3 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The investigators aim to compare subacromial ketorolac (non-steroidal anti-inflammatory drug) versus methylprednisolone (steroid) for the treatment of shoulder impingement syndrome.
Detailed description
Because of the current conflicting evidence, the lack of long-term follow-up, and the multiple potential benefit benefits to the society, the investigators aim to compare subacromial ketorolac versus methylprednisolone for the treatment of shoulder impingement syndrome. The investigators hypothesize that patients with shoulder impingement treated with a subacromial methylprednisolone versus ketorolac have similar outcomes based on the ASES (American Shoulder and Elbow Surgeon) self-assessment score. The study will be performed at one institution, the University of Texas Medical Branch.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Randomized clinical trial in which patients will be randomized to receive subacromial injection with either methylprednisolone or ketorolac.
| Arm | Type | Receives |
|---|---|---|
| Ketorolac | Active comparator | Drug: Ketorolac TromethamineAssigned patients will receive a subacromial injection of ketorolac 60mg (2ml + 8ml lidocaine 1%) |
| Methylprednisolone | Active comparator | Drug: Methylprednisolone AcetateAssigned patients will receive a subacromial injection of methylprednisolone 80mg (1ml + 9ml lidocaine 1%) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >18 years
- Severe or recalcitrant shoulder impingement syndrome
- Subacromial injection is a therapeutic option
Key exclusion criteria (21 listed)
- Allergy or intolerance to steroids within less than 1 month
- Allergy or intolerance to NSAIDs within less than 1 month
- Pregnancy
- Breastfeeding
- Pre-existing asthma
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 |
|---|---|---|
| Ketorolac TromethamineAlso: Toradol2ml of injectable Ketorolac (30mg/ml) will be mixed with 8ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 60mg of active substance in 10ml). | Drug | Ketorolac |
| Methylprednisolone AcetateAlso: DepoMedrol1ml of injectable Methylprednisolone (80mg/ml) will be mixed with 9ml of lidocaine HCL (1% without epinephrine) and delivered into the subacromial joint (total of 80mg of active substance in 10ml) | Drug | Methylprednisolone |
Primary outcome
American Shoulder and Elbow Surgeon (ASES)
Time frame: 12 weeks
The ASES is a self-assessment score, ranging between 0 and 100 (0 indicating the worst shoulder condition and 100 indicating the best shoulder condition), applicable for use in patients with shoulder pathology. A higher pain score indicates the subject is in more pain. A lower pain score indicates less pain.
3 secondary outcomes
American Shoulder and Elbow Surgeon (ASES)
Time frame: 2 weeks
American Shoulder and Elbow Surgeon (ASES)
Time frame: 4 weeks
Range of Motion (ROM)
Time frame: 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. At the end of this investigation, IPD-related results will be tabulated and submitted to clinicaltrials.gov to report. This would help evaluate the effects and safety of interventions administered.
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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.
Jeremy Somerson, MD principal investigator
University of Texas
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Ketorolac Tromethamine and Methylprednisolone Acetate in people with Subacromial Impingement and Subacromial Impingement Syndrome, run by The University of Texas Medical Branch, Galveston at 1 site in United States.
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 3 inclusion and 21 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: stopped early, as of the sponsor's last update on 3 Jan 2025. 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 States. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 3 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
American Shoulder and Elbow Surgeon (ASES) (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Jan 2025.