Shoulder PainPhase 4NCT05438277
Pain Increases After Shoulder Injection
A Phase 4 study testing Methylprednisolone (MPA) and Triamcinolone Acetonide (TA) in people with Shoulder Pain, run by Campbell Clinic at 1 site in United States.
Trial summary
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection. Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Shoulder Pain
- What is being tested?
- Methylprednisolone (MPA) and Triamcinolone Acetonide (TA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 421 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2020to 30 Sep 2022
- Phase
- Phase 4
- 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 99 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subacromial or glenohumeral shoulder pain to be treated with steroid injection
- Fluent in written and oral English
- Willing and able to provide written consent
- Willing to complete follow up pain scores (visual analog score)
Who cannot join
- Unable to provide written consent
- Chronic pain syndrome
- Unwilling to complete follow up pain scores (visual analog score)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.
Read the detailed description
Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space.
Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.
- Conditions
- Shoulder Pain
- Being tested
- Methylprednisolone (MPA), Triamcinolone Acetonide (TA)
- Medical subject headings
- Shoulder Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone (MPA)Drug
Also called depomedrol
injection into subacromial or glenohumeral space with MPA
Triamcinolone Acetonide (TA)Drug
Also called kenalog
injection into subacromial or glenohumeral space with TA
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone acetate (MPA) | Experimental | subacromial or glenohumeral shoulder injection Receives: Drug: Methylprednisolone (MPA) |
| triamcinolone acetonide (TA) | Active comparator | subacromial or glenohumeral shoulder injection Receives: Drug: Triamcinolone Acetonide (TA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of a Flare Reaction
A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain.
Measured: Post-injection day 1 through 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2022
- Study start1 Jan 2020
- Primary completion31 Aug 2022
- Study completion30 Sep 2022
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 Shoulder PainStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 421 participants (actual)
Sponsor and investigators
- Lead sponsor
- Campbell Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tyler J. Brolin, Campbell Clinic
- Investigators
- Tyler Brolin, MD, Principal investigator, Campbell Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05438277
- Sponsor's protocol ID
- IRB 7001-XP
- Status last verified
- Feb 2023
- First submitted
- 24 Jun 2022
- Last updated
- 7 Mar 2023
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence of Flare Reaction Following Shoulder Steroid Injections: Comparison of Depo-medrol (Methylprednisolone) and Kenalog (Triamcinolone)
- ClinicalTrials.gov ID
- NCT05438277
- Acronym / sponsor ID
- IRB 7001-XP
- Conditions
- Shoulder Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 421 participants (actual)
- Lead sponsor
- Campbell ClinicUniversity, hospital or other
- Study start
- 1 Jan 2020 (actual)
- Primary completion
- 31 Aug 2022 (actual)
- Study completion
- 30 Sep 2022 (actual)
- First posted
- 29 Jun 2022 (actual)
- Results
- Posted 7 Mar 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Compare FLARE reactions (increase in VAS by two or more points) in the first 48 hours following a shoulder injection.
Detailed description
Corticosteroid injections are used to reduce pain and inflammation for various shoulder pathologies. Corticosteroid flare reaction is a well-described phenomenon that, despite being self-limited, causes significant pain and dysfunction. A flare reaction is defined for the purposes the study to be an increase of two or more points on a visual analog scale reported by the subject. Currently, there is a paucity of literature to drive the decision-making process between different corticosteroid medications. This study will compare the incidences of steroid flare reaction and three-month efficacy following methylprednisolone acetate (MPA) and triamcinolone acetonide (TA) corticosteroid injections into the glenohumeral joint or subacromial space.
Physicians administering a steroid injection in the shoulder will utilize MPA until 200 subjects have agreed to participate in this treatment arm. Enrollment will then be offered to 200 subjects utilizing TA for the shoulder injection. Subjects receive treatment for their shoulder pain regardless of willingness to participate in the follow up reported pain scores. There are no costs to subjects for study participation.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone acetate (MPA) | Experimental | Drug: Methylprednisolone (MPA)subacromial or glenohumeral shoulder injection |
| triamcinolone acetonide (TA) | Active comparator | Drug: Triamcinolone Acetonide (TA)subacromial or glenohumeral shoulder injection |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subacromial or glenohumeral shoulder pain to be treated with steroid injection
- Fluent in written and oral English
- Willing and able to provide written consent
- Willing to complete follow up pain scores (visual analog score)
Key exclusion criteria (3 listed)
- Unable to provide written consent
- Chronic pain syndrome
- Unwilling to complete follow up pain scores (visual analog score)
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 |
|---|---|---|
| Methylprednisolone (MPA)Also: depomedrolinjection into subacromial or glenohumeral space with MPA | Drug | methylprednisolone acetate (MPA) |
| Triamcinolone Acetonide (TA)Also: kenaloginjection into subacromial or glenohumeral space with TA | Drug | triamcinolone acetonide (TA) |
Primary outcome
Incidence of a Flare Reaction
Time frame: Post-injection day 1 through 7
A flare reaction was defined as an increase of two or more points of Visual Analog Score (VAS) score during the first week following injection. The VAS is a patient reported pain score from zero to ten where zero is no pain and ten is the most pain.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
Related trials for Shoulder Pain
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Nociplastic Pain in Patients Diagnosed With Subacromial Pain Syndrome (SAPS)
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Latissimus Dorsi Strengthening Exercises in Rotator Cuff Tendinopathy
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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.
Tyler Brolin, MD principal investigator
Campbell Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone (MPA) and Triamcinolone Acetonide (TA) in people with Shoulder Pain, run by Campbell Clinic 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 4 inclusion and 3 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: finished, as of the sponsor's last update on 7 Mar 2023. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 7 Mar 2023). 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?
Incidence of a Flare Reaction (time frame: Post-injection day 1 through 7). 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 7 Mar 2023.