Osteoarthritis
Conditions
Keywords
osteoarthritis, injection, steroid, anesthetic
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.
Interventions
DRUGRopivacaine
4cc 0.5% ropivacaine
DRUGNormal saline
4cc of sterile normal saline (0.9%)
DRUGMethylprednisolone
1cc 40mg methylprednisolone
Sponsors
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale | 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
| Measure | Time frame | Description |
|---|---|---|
| Pain Scale Score | 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. |
| Tegner Activity Level Scale | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ropivacaine and Methylprednisolone 0.2% ropivacaine and methylprednisolone knee joint injection | 15 |
| Saline and Methylprednisolone 0.9% normal saline and methylprednisolone knee joint injection | 14 |
| Total | 29 |
Baseline characteristics
| Characteristic | Saline and Methylprednisolone | Total | Ropivacaine and Methylprednisolone |
|---|---|---|---|
| Age, Continuous | 57 years STANDARD_DEVIATION 11.8 | 57 years STANDARD_DEVIATION 9.58 | 57 years STANDARD_DEVIATION 7.43 |
| Body Mass Index (BMI) | 30.9 kg/m^2 STANDARD_DEVIATION 6.46 | 30.4 kg/m^2 STANDARD_DEVIATION 7.01 | 29.9 kg/m^2 STANDARD_DEVIATION 7.68 |
| Knee Effusion No | 10 Participants | 20 Participants | 10 Participants |
| Knee Effusion Yes | 4 Participants | 9 Participants | 5 Participants |
| Region of Enrollment United States | 14 Participants | 29 Participants | 15 Participants |
| Sex: Female, Male Female | 8 Participants | 16 Participants | 8 Participants |
| Sex: Female, Male Male | 6 Participants | 13 Participants | 7 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 15 | 0 / 14 |
| other Total, other adverse events | 0 / 15 | 0 / 14 |
| serious Total, serious adverse events | 0 / 15 | 0 / 14 |
Outcome results
Primary
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.
Time frame: 3 months after the injection
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Ropivacaine and Methylprednisolone | The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale | 63.1 units on a scale | Standard Deviation 16.1 |
| Saline and Methylprednisolone | The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale | 67.2 units on a scale | Standard Deviation 14.4 |
Secondary
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.
Time frame: Pre-injection, immediately post-injection, 2 weeks, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine and Methylprednisolone | Pain Scale Score | 2 Weeks Activity | 3.6 units on a scale | Standard Deviation 2.5 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | Pre-injection Activity | 6.4 units on a scale | Standard Deviation 2 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | 2 Weeks Rest | 1.7 units on a scale | Standard Deviation 2 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | Immediately Post-injection Activity | 1.9 units on a scale | Standard Deviation 2.3 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | 3 Months Activity | 3.9 units on a scale | Standard Deviation 2.7 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | Pre-injection Rest | 2.4 units on a scale | Standard Deviation 2 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | 3 Months Rest | 2.6 units on a scale | Standard Deviation 2.2 |
| Ropivacaine and Methylprednisolone | Pain Scale Score | Immediately Post-injection Rest | 1.2 units on a scale | Standard Deviation 1.5 |
| Saline and Methylprednisolone | Pain Scale Score | 3 Months Rest | 2.8 units on a scale | Standard Deviation 2.4 |
| Saline and Methylprednisolone | Pain Scale Score | Pre-injection Activity | 5.8 units on a scale | Standard Deviation 2.5 |
| Saline and Methylprednisolone | Pain Scale Score | Pre-injection Rest | 4 units on a scale | Standard Deviation 2 |
| Saline and Methylprednisolone | Pain Scale Score | Immediately Post-injection Activity | 2.4 units on a scale | Standard Deviation 2.2 |
| Saline and Methylprednisolone | Pain Scale Score | 2 Weeks Activity | 3.6 units on a scale | Standard Deviation 2 |
| Saline and Methylprednisolone | Pain Scale Score | 2 Weeks Rest | 2.7 units on a scale | Standard Deviation 2.2 |
| Saline and Methylprednisolone | Pain Scale Score | 3 Months Activity | 4.6 units on a scale | Standard Deviation 2.4 |
| Saline and Methylprednisolone | Pain Scale Score | Immediately Post-injection Rest | 1.4 units on a scale | Standard Deviation 1.7 |
Secondary
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.
Time frame: baseline (pre-injection), 2 weeks, 3 months
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Ropivacaine and Methylprednisolone | Tegner Activity Level Scale | baseline (pre-injection) | 3.5 units on a scale | Standard Deviation 2.2 |
| Ropivacaine and Methylprednisolone | Tegner Activity Level Scale | 2 weeks | 4.3 units on a scale | Standard Deviation 1.7 |
| Ropivacaine and Methylprednisolone | Tegner Activity Level Scale | 3 months | 3.5 units on a scale | Standard Deviation 2.1 |
| Saline and Methylprednisolone | Tegner Activity Level Scale | baseline (pre-injection) | 3.0 units on a scale | Standard Deviation 1.6 |
| Saline and Methylprednisolone | Tegner Activity Level Scale | 2 weeks | 3.2 units on a scale | Standard Deviation 1.3 |
| Saline and Methylprednisolone | Tegner Activity Level Scale | 3 months | 3 units on a scale | Standard Deviation 1.7 |