Systemic Oral Glucocorticoids for the Treatment of Acute Osteoarthritis Pain in the Emergency Department

Part of paid clinical trials in York, Pennsylvania.

Sponsor
WellSpan Health
Study ID
NCT06603662
Phase
PHASE4
Status
Recruiting
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Conditions

  • Osteoarthritis
  • Osteoarthritis (OA) of the Hip
  • Osteoarthritis (OA) of the Knee
  • Osteoarthritis (OA) of the Shoulder

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Prednisone — DRUG
    Subjects assigned to the Intervention A group will receive oral prednisone 50 mg once a day for 5 days, plus standard ibuprofen 600 mg every 8 hours for 5 days.
  • Dexamethasone — DRUG
    Subjects assigned to the Intervention B group will receive a single oral dose of dexamethasone 10 mg, plus standard ibuprofen 600 mg every 8 hours for 5 days.
  • Placebo — DRUG
    Subjects assigned to the Control group will receive oral placebo once a day for 5 days, plus standard ibuprofen 600 mg every 8 hours.

Study Details

The purpose of this clinical trial is to compare the analgesic effects (relief of pain) of glucocorticoids (steroids) and pain medication versus pain medication alone in adult patients presenting to the emergency department with joint pain due to osteoarthritis. Steroids are drugs that can reduce inflammation and are used commonly for many different medical conditions. In brief, the central aims of the study are to: 1. Assess the efficacy of adding oral glucocorticoid medications to the standard pain medications used to treat the pain of osteoarthritis. 2. Assess the safety and tolerability of oral glucocorticoid medication for the short-term treatment of osteoarthritis pain. We hypothesize that: 1) The addition of glucocorticoids to standard pain medications will improve reported pain scores at 3 days following the initiation of treatment compared to standard pain medications alone and 2) The use of glucocorticoids will be well tolerated. Participants in the study will be randomized (like flipping a coin) into one of three groups: 1. Study Group 1 (Control) receiving placebo pills (no active ingredient) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 2. Study Group 2 (Intervention A) who will receive prednisone (steroid) once a day for 5 days, plus ibuprofen (pain medication) for 5 days. 3. Study Group 3 (Intervention B) who will receive one dose of dexamethasone (steroid) followed by placebo pills (no active ingredient) once a day for 4 days, plus ibuprofen (pain medication) for 5 days. In all groups, acetaminophen (a different pain medication) can be taken as needed for pain that is not controlled with ibuprofen. Participants will: * Receive follow up phone calls at 1, 3, 7 and 14 days. * Report pain scores related to joint pain. * Report the number of pills taken of the various medications used in the study. * Report any adverse events incurred during the follow up period.

Key Dates

Start date
Feb 24, 2025
Status verified
Mar 2025
Primary completion
Oct 31, 2027
Completion
Dec 31, 2027

Study Design

Enrollment
192 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Active Comparator: Intervention A - Prednisone
    Subjects assigned to the Intervention A group will receive prednisone 50 mg once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.
  • Active Comparator: Intervention B - Dexamethasone
    Subjects assigned to the Intervention B group will receive a single dose of dexamethasone 10 mg, plus ibuprofen 600 mg every 8 hours for 5 days.
  • Placebo Comparator: Control - Placebo
    Subjects assigned to the Control group will receive placebo once a day for 5 days, plus ibuprofen 600 mg every 8 hours for 5 days.

Primary Outcome Measure

Change in Resting Pain Score at 3 Days (Effectiveness Outcome) [ Time Frame: 3 days (72 hours) ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
WellSpan York HospitalYorkPennsylvania17403
Kristen Oliff
[email protected]
717-812-5075
Brent Becker, MD
[email protected]
717-851-4819

Find similar trials in York, PA

By condition
Osteoarthritis (other)
By specialty
OrthopedicsMusculoskeletal disorders
By research site
WellSpan York Hospital· York, PA

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