Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis

NCT ID: NCT02576249

Last Updated: 2017-08-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-10-31
• Study Completion Date: 2016-10-31

Brief Summary

Corticosteroid injections are commonly used for the symptomatic treatment of knee osteoarthritis. Common practice is to inject the joint with a combination of corticosteroid and local anesthetic, with the rationale of providing longer duration pain relief with the corticosteroid and immediate, though short duration relief with the anesthetic. However, multiple in vitro and animal studies have shown that local anesthetic may be harmful to chondrocytes. Despite this data, use of intra-articular anesthetic remains widespread. Many clinicians believe incorporating the anesthetic is important because it can provide immediate pain relief and facilitate patient confidence in the treatment program. However, there is no published data to validate this reasoning. Therefore, the anesthetic has unknown clinical benefit and may have adverse effects on articular cartilage. In light of this, the investigators question the routine use of anesthetics in joint injections. The purpose of this study is to compare the effects of knee joint injections using: 1) corticosteroid with local anesthetic versus 2) corticosteroid with normal saline.

Conditions

Osteoarthritis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Ropivacaine and Methylprednisolone

0.2% ropivacaine and methylprednisolone knee joint injection

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

4cc 0.5% ropivacaine

Methylprednisolone

Intervention Type: DRUG

1cc 40mg methylprednisolone

Saline and Methylprednisolone

0.9% normal saline and methylprednisolone knee joint injection

Group Type: EXPERIMENTAL

Normal saline

Intervention Type: DRUG

4cc of sterile normal saline (0.9%)

Methylprednisolone

Intervention Type: DRUG

1cc 40mg methylprednisolone

Interventions

Ropivacaine

4cc 0.5% ropivacaine

Intervention Type: DRUG

Normal saline

4cc of sterile normal saline (0.9%)

Intervention Type: DRUG

Methylprednisolone

1cc 40mg methylprednisolone

Intervention Type: DRUG

Other Intervention Names

Naropin; Sodium Chloride; Depo-Medrol

Eligibility Criteria

Inclusion Criteria

1. Age 18 or older

2. Knee osteoarthritis (uni- or bilateral) as defined by the American College of Rheumatology (staged by Kellgren-Lawrence radiographic grading scale)

Exclusion Criteria

1. Rheumatologic/inflammatory disease

2. Metabolic bone disease

3. Crystalline arthropathy

4. Current smoking

5. BMI > 40

6. Knee injection with corticosteroid or viscosupplementation within previous 6 months

7. History of knee prolotherapy, platelet rich plasma or cellular (stem cell) injection

8. Knee surgery within the last year

9. Chronic opioid use

10. Chronic pain syndrome/fibromyalgia

11. Pain behavior during the clinical encounter as judged by the injecting physician

12. Physician specifically ordered injection of corticosteroid/anesthetic or other specific combined corticosteroid injection

13. Diagnostic uncertainty by referring provider

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Jacob L. Sellon, M.D.

Assistant Professor of Physical Medicine and Rehabilitation

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jacob L Sellon, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic in Rochester

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

15-003120

Identifier Type: -

Identifier Source: org_study_id