OsteoarthritisPhase 4NCT02576249
Corticosteroid/Ropivacaine Versus Corticosteroid/Saline Injections for Knee Osteoarthritis
A Phase 4 study testing Ropivacaine, Normal saline and Methylprednisolone in people with Osteoarthritis, run by Mayo Clinic at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Osteoarthritis
- What is being tested?
- Ropivacaine, Normal saline and Methylprednisolone
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2015to Oct 2016
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- Knee osteoarthritis (uni- or bilateral) as defined by the American College of Rheumatology (staged by Kellgren-Lawrence radiographic grading scale)
Who cannot join
- Rheumatologic/inflammatory disease
- Metabolic bone disease
- Crystalline arthropathy
- Current smoking
- BMI > 40
- Knee injection with corticosteroid or viscosupplementation within previous 6 months
Show all 14Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
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
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
- Being tested
- Ropivacaine, Normal saline, Methylprednisolone
- Keywords
- osteoarthritis, injection, steroid, anesthetic
- Medical subject headings
- Osteoarthritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RopivacaineDrug
Also called Naropin
4cc 0.5% ropivacaine
Normal salineDrug
Also called Sodium Chloride
4cc of sterile normal saline (0.9%)
Also called Depo-Medrol
1cc 40mg methylprednisolone
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine and Methylprednisolone | Active comparator | 0.2% ropivacaine and methylprednisolone knee joint injection Receives: Drug: Ropivacaine; Drug: Methylprednisolone |
| Saline and Methylprednisolone | Experimental | 0.9% normal saline and methylprednisolone knee joint injection Receives: Drug: Normal saline; Drug: Methylprednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the injection
Secondary outcomes (2)
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.
Measured: Pre-injection, immediately post-injection, 2 weeks, 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.
Measured: baseline (pre-injection), 2 weeks, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2015 (estimated)
- Study startOct 2015
- Primary completionJul 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for OsteoarthritisStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jacob L. Sellon, M.D., Mayo Clinic
- Investigators
- Jacob L Sellon, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02576249
- Sponsor's protocol ID
- 15-003120
- Status last verified
- Jul 2017
- First submitted
- 13 Oct 2015
- Last updated
- 21 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02576249
- Acronym / sponsor ID
- 15-003120
- Conditions
- Osteoarthritis
- Keywords
- osteoarthritis, injection, steroid, anesthetic
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- Oct 2015
- Primary completion
- Jul 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 15 Oct 2015 (estimated)
- Results
- Posted 21 Jul 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine and Methylprednisolone | Active comparator | Drug: Ropivacaine, Drug: Methylprednisolone0.2% ropivacaine and methylprednisolone knee joint injection |
| Saline and Methylprednisolone | Experimental | Drug: Normal saline, Drug: Methylprednisolone0.9% normal saline and methylprednisolone knee joint injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Age 18 or older
- Knee osteoarthritis (uni- or bilateral) as defined by the American College of Rheumatology (staged by Kellgren-Lawrence radiographic grading scale)
Key exclusion criteria (14 listed)
- Rheumatologic/inflammatory disease
- Metabolic bone disease
- Crystalline arthropathy
- Current smoking
- BMI > 40
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| RopivacaineAlso: Naropin4cc 0.5% ropivacaine | Drug | Ropivacaine and Methylprednisolone |
| Normal salineAlso: Sodium Chloride4cc of sterile normal saline (0.9%) | Drug | Saline and Methylprednisolone |
| MethylprednisoloneAlso: Depo-Medrol1cc 40mg methylprednisolone | Drug | Ropivacaine and Methylprednisolone, Saline and Methylprednisolone |
Primary outcome
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.
2 secondary outcomes
Pain Scale Score
Time frame: Pre-injection, immediately post-injection, 2 weeks, 3 months
Tegner Activity Level Scale
Time frame: baseline (pre-injection), 2 weeks, 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacob L Sellon, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ropivacaine, Normal saline and Methylprednisolone in people with Osteoarthritis, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Knee Osteoarthritis Outcome Score (KOOS) Pain Subscale (time frame: 3 months after the injection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2017.