Oral Steroids for Osteoarthritis Pain

Recruiting in Palo Alto (17 mi)

Overseen byBrent Becker, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 4

Recruiting

Sponsor: WellSpan Health

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Brent Becker, MD

Principal Investigator

WellSpan Health

Eligibility Criteria

Adults with joint pain from osteoarthritis visiting the emergency department can join. They'll be testing if adding steroids to standard pain meds helps more than just pain meds alone.

Inclusion Criteria

I am 18 years old or older.

I have severe joint pain in my knee, hip, or shoulder due to arthritis.

I started feeling more pain than usual less than 3 days ago.

See 2 more

Exclusion Criteria

I have had joint replacement surgery on the affected joint.

Illicit drug use

I cannot take ibuprofen/NSAIDs or steroids due to other health reasons.

See 12 more

Treatment Details

Interventions

Dexamethasone (Corticosteroid)
Prednisone (Corticosteroid)

Trial OverviewThe trial is checking if oral steroids (Prednisone or Dexamethasone) plus ibuprofen relieve osteoarthritis pain better than placebo pills with ibuprofen. Participants are randomly assigned to one of three groups and followed up for two weeks.

Participant Groups

3Treatment groups

Active Control

Placebo Group

Group I: Intervention A - PrednisoneActive Control1 Intervention

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.

Group II: Intervention B - DexamethasoneActive Control1 Intervention

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.

Group III: Control - PlaceboPlacebo Group1 Intervention

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.

Dexamethasone is already approved in Canada, Japan for the following indications: