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Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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:
Information provided by (Responsible Party):
Jacob L. Sellon, M.D., Mayo Clinic

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

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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


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




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.




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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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02576249


Locations
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United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
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Principal Investigator: Jacob L Sellon, MD Mayo Clinic
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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    Key Record Dates
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

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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:
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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