Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis
Primary Purpose
Osteoarthritis
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Normal saline
Methylprednisolone
Sponsored by
About this trial
This is an interventional treatment trial for Osteoarthritis focused on measuring osteoarthritis, injection, steroid, anesthetic
Eligibility Criteria
Inclusion criteria:
- Age 18 or older
- Knee osteoarthritis (uni- or bilateral) as defined by the American College of Rheumatology (staged by Kellgren-Lawrence radiographic grading scale)
Exclusion criteria:
- Rheumatologic/inflammatory disease
- Metabolic bone disease
- Crystalline arthropathy
- Current smoking
- BMI > 40
- Knee injection with corticosteroid or viscosupplementation within previous 6 months
- History of knee prolotherapy, platelet rich plasma or cellular (stem cell) injection
- Knee surgery within the last year
- Chronic opioid use
- Chronic pain syndrome/fibromyalgia
- Pain behavior during the clinical encounter as judged by the injecting physician
- Physician specifically ordered injection of corticosteroid/anesthetic or other specific combined corticosteroid injection
- Diagnostic uncertainty by referring provider
- 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)
Sites / Locations
- Mayo Clinic in Rochester
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Ropivacaine and Methylprednisolone
Saline and Methylprednisolone
Arm Description
0.2% ropivacaine and methylprednisolone knee joint injection
0.9% normal saline and methylprednisolone knee joint injection
Outcomes
Primary Outcome Measures
The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
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
Pain Scale Score
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.
Tegner Activity Level Scale
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02576249
Brief Title
Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis
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 Type
Interventional
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
October 2015 (undefined)
Primary Completion Date
July 2016 (Actual)
Study Completion Date
October 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
4. Oversight
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
Data Monitoring Committee
No
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteoarthritis
Keywords
osteoarthritis, injection, steroid, anesthetic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
29 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ropivacaine and Methylprednisolone
Arm Type
Active Comparator
Arm Description
0.2% ropivacaine and methylprednisolone knee joint injection
Arm Title
Saline and Methylprednisolone
Arm Type
Experimental
Arm Description
0.9% normal saline and methylprednisolone knee joint injection
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
4cc 0.5% ropivacaine
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Sodium Chloride
Intervention Description
4cc of sterile normal saline (0.9%)
Intervention Type
Drug
Intervention Name(s)
Methylprednisolone
Other Intervention Name(s)
Depo-Medrol
Intervention Description
1cc 40mg methylprednisolone
Primary Outcome Measure Information:
Title
The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale
Description
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.
Time Frame
3 months after the injection
Secondary Outcome Measure Information:
Title
Pain Scale Score
Description
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.
Time Frame
Pre-injection, immediately post-injection, 2 weeks, 3 months
Title
Tegner Activity Level Scale
Description
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.
Time Frame
baseline (pre-injection), 2 weeks, 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion criteria:
Age 18 or older
Knee osteoarthritis (uni- or bilateral) as defined by the American College of Rheumatology (staged by Kellgren-Lawrence radiographic grading scale)
Exclusion criteria:
Rheumatologic/inflammatory disease
Metabolic bone disease
Crystalline arthropathy
Current smoking
BMI > 40
Knee injection with corticosteroid or viscosupplementation within previous 6 months
History of knee prolotherapy, platelet rich plasma or cellular (stem cell) injection
Knee surgery within the last year
Chronic opioid use
Chronic pain syndrome/fibromyalgia
Pain behavior during the clinical encounter as judged by the injecting physician
Physician specifically ordered injection of corticosteroid/anesthetic or other specific combined corticosteroid injection
Diagnostic uncertainty by referring provider
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacob L Sellon, MD
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic in Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis
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