Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis

• ClinicalTrials.gov Identifier: NCT02576249
• Recruitment Status: Completed
• First Posted: October 15, 2015
• Results First Posted: July 21, 2017
• Last Update Posted: August 21, 2017
• Sponsor: Mayo Clinic
• Information provided by (Responsible Party): Jacob L. Sellon, M.D., Mayo Clinic

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Osteoarthritis	Drug: Ropivacaine; Drug: Normal saline; Drug: Methylprednisolone	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 29 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: Does Anesthetic Contribute to Symptomatic Relief in Corticosteroid Injections for Knee Osteoarthritis? A Double-Blind Randomized Trial Comparing Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections
• Study Start Date: October 2015
• Actual Primary Completion Date: July 2016
• Actual Study Completion Date: October 2016

Arms and Interventions

Arm	Intervention/treatment
Active Comparator: Ropivacaine and Methylprednisolone; 0.2% ropivacaine and methylprednisolone knee joint injection	Drug: Ropivacaine; 4cc 0.5% ropivacaine; Other Name: Naropin; Drug: Methylprednisolone; 1cc 40mg methylprednisolone; Other Name: Depo-Medrol
Experimental: Saline and Methylprednisolone; 0.9% normal saline and methylprednisolone knee joint injection	Drug: Normal saline; 4cc of sterile normal saline (0.9%); Other Name: Sodium Chloride; Drug: Methylprednisolone; 1cc 40mg methylprednisolone; Other Name: Depo-Medrol

Outcome Measures

Primary Outcome Measures :

1. The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale [ Time Frame: 3 months after the injection ]
   The KOOS holds 42 items in five separately scored subscales: Pain, other Symptoms, Function in daily living (ADL), Function in Sport and Recreation (Sport/Rec), and knee-related Quality of Life (QOL). A Likert scale is used and all items have five possible answer options scored from 0 (No Problems) to 4 (Extreme Problems) and each of the five scores is calculated as the sum of the items included. Scores are transformed to a 0-100 scale, with zero representing extreme knee problems and 100 representing no knee problems.

Secondary Outcome Measures :

1. Pain Scale Score [ Time Frame: Pre-injection, immediately post-injection, 2 weeks, 3 months ]
   Pain was measured by a Visual Analog Scale (VAS) marked from 0 (no pain) to 10 (unbearable pain) at rest and with activity. It was collected at baseline (pre-injection), immediately post-injection on the day of surgery, and at 2 weeks and 3 months.
2. Tegner Activity Level Scale [ Time Frame: baseline (pre-injection), 2 weeks, 3 months ]

   The Tegner activity level scale is a scale that aims to provide a standardized method of grading work and sporting activities. The Tegner activity level scale is a graduated list of activities of daily living, recreation, and competitive sports. The patient is asked to select the level of participation that best describes their current level of activity and that before injury.

   A score of 0 represents sick leave or disability pension because of knee problems, whereas a score of 10 corresponds to participation in national and international elite competitive sports. A score >6 can only be achieved if the person participates in recreational or competitive sport.

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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
14. Referral for bilateral knee or multiple joint injections (*note that arthritis involving multiple joints alone is not an exclusion criteria, only the patient receiving more than 1 injection)

Contacts and Locations

Locations

United States, Minnesota

Mayo Clinic in Rochester

Rochester, Minnesota, United States, 55905

Sponsors and Collaborators

Mayo Clinic

Investigators

• Principal Investigator: Jacob L Sellon, MD; Mayo Clinic

More Information

• Responsible Party: Jacob L. Sellon, M.D., Assistant Professor of Physical Medicine and Rehabilitation, Mayo Clinic
• ClinicalTrials.gov Identifier: NCT02576249
• Other Study ID Numbers: 15-003120
• First Posted: October 15, 2015
• Results First Posted: July 21, 2017
• Last Update Posted: August 21, 2017
• Last Verified: July 2017

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Jacob L. Sellon, M.D., Mayo Clinic:

osteoarthritis; injection; steroid; anesthetic

Additional relevant MeSH terms:

Osteoarthritis; Osteoarthritis, Knee; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Ropivacaine; Prednisolone hemisuccinate; Prednisolone phosphate; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents; Anti-Inflammatory Agents; Antiemetics; Autonomic Agents; Gastrointestinal Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Neuroprotective Agents; Protective Agents; Antineoplastic Agents, Hormonal