ShoulderPhase 4NCT07902843
Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
A Phase 4 study testing Methylprednisolone taper in people with Shoulder, run by The Hawkins Foundation at 1 site in United States.
Trial summary
The use of Methylprednisolone Taper will be investigated in the setting of a Rotator Cuff Repair to determine if it will result in lower pain levels following surgery Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Shoulder
- What is being tested?
- Methylprednisolone taper
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Dec 2026to 30 Apr 2029
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- undergoing a rotator cuff repair.
Who cannot join
- patients with concurrent and significant injury to other bones or organs
- a history of alcohol or substance abuse
- a history of severe heart disease
- a history of renal failure, a history of liver dysfunction
- active peptic ulcer disease
- neurological or psychiatric diseases that may affect pain perception
- active pregnancy
- uncontrolled diabetes mellitus
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
Steadman Hawkins Clinic of the Carolinas, Prisma Health
Greenville, South Carolina, 29615
Allison A Nall, MS, 864-454-7458, allison.nall@hawkinsfoundation.com
About this study
The use of Methylprednisolone Taper will be investigated in the setting of a Rotator Cuff Repair to determine if it will result in lower pain levels following surgery
Read the detailed description
Rotator cuff repairs, as with many other orthopaedic procedures, often cause post-operative surgical site swelling. This inflammation can lead to pain and reduce healing, if excessive. The methylprednisone taper is an oral corticosteroid medication prescribed for 6 days that aims to decrease inflammation, which in turn can decrease pain. Since the methylprednisone taper pack reduces the amount of medication used over the six days, it is considered safe in the post-operative phase, as shown in prior studies (Wagner et al). Wagner et al. investigated using the methylprednisone taper pack in patients after shoulder arthroplasty and found it was safe and very effective at reducing opioid consumption and reducing pain levels.
Subjects will be randomized between treatment with or without a Methylprednisolone taper when undergoing Rotator Cuff Repair.
- Conditions
- Shoulder
- Being tested
- Methylprednisolone taper
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone taperDrug
Methylprednisolone taper 6 day taper
| Study group | Role | What they receive |
|---|---|---|
| Control | No intervention | Not described |
| Investigational | Experimental | Investigational group receives Methylprednisolone Taper Receives: Drug: Methylprednisolone taper |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
Scale from 0 to 10 rate pain
Measured: Daily, first 7 post-operative days
Narcotic Drug use
Count of prescription pain medicine taken first 7 post-operative days
Measured: Daily, first 7 post-operative days
Secondary outcomes (2)
Shoulder range of motion
Range of motion
Measured: 3 months post op
ASES (American Shoulder and Elbow Surgeon questionnaire)
Survey, range 0-100 with higher scores indicating better function
Measured: 3 months post-op
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2026
- Study start1 Dec 2026 (estimated)
- Primary completion31 Dec 2028 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShoulderStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Hawkins Foundation
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07902843
- Sponsor's protocol ID
- 2403627-2
- Status last verified
- Oct 2026
- First submitted
- 23 Oct 2026
- Last updated
- 30 Oct 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methylprednisolone Taper is an Effective Addition to Multimodal Pain Regimens After Rotator Cuff Repair
- ClinicalTrials.gov ID
- NCT07902843
- Acronym / sponsor ID
- 2403627-2
- Conditions
- Shoulder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- The Hawkins FoundationUniversity, hospital or other
- Study start
- 1 Dec 2026 (estimated)
- Primary completion
- 31 Dec 2028 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 29 Oct 2026 (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.
The use of Methylprednisolone Taper will be investigated in the setting of a Rotator Cuff Repair to determine if it will result in lower pain levels following surgery
Detailed description
Rotator cuff repairs, as with many other orthopaedic procedures, often cause post-operative surgical site swelling. This inflammation can lead to pain and reduce healing, if excessive. The methylprednisone taper is an oral corticosteroid medication prescribed for 6 days that aims to decrease inflammation, which in turn can decrease pain. Since the methylprednisone taper pack reduces the amount of medication used over the six days, it is considered safe in the post-operative phase, as shown in prior studies (Wagner et al). Wagner et al. investigated using the methylprednisone taper pack in patients after shoulder arthroplasty and found it was safe and very effective at reducing opioid consumption and reducing pain levels.
Subjects will be randomized between treatment with or without a Methylprednisolone taper when undergoing Rotator Cuff Repair.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | No intervention | – |
| Investigational | Experimental | Drug: Methylprednisolone taperInvestigational group receives Methylprednisolone Taper |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- undergoing a rotator cuff repair.
Key exclusion criteria (8 listed)
- patients with concurrent and significant injury to other bones or organs
- a history of alcohol or substance abuse
- a history of severe heart disease
- a history of renal failure, a history of liver dysfunction
- active peptic ulcer disease
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 taperMethylprednisolone taper 6 day taper | Drug | Investigational |
Primary outcome
Numeric Rating Scale
Time frame: Daily, first 7 post-operative days
Scale from 0 to 10 rate pain
Narcotic Drug use
Time frame: Daily, first 7 post-operative days
Count of prescription pain medicine taken first 7 post-operative days
2 secondary outcomes
Shoulder range of motion
Time frame: 3 months post op
ASES (American Shoulder and Elbow Surgeon questionnaire)
Time frame: 3 months post-op
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 2026.
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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.
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 taper in people with Shoulder, run by The Hawkins Foundation 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 1 inclusion and 8 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: opening soon, as of the sponsor's last update on 30 Oct 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Stephan G Pill, MD (864-454-7458, stephan.pill@prismahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Daily, first 7 post-operative days). The study lists 2 primary outcomes in all. 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 30 Oct 2026.