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Non-Surgical Interventions for Knee Osteoarthritis (SKOAP Trial)
Phase 3
Recruiting
Led By Steven Cohen, MD
Research Sponsored by Johns Hopkins University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses.
Awards & highlights
SKOAP Trial Summary
This trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA. The results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.
Who is the study for?
This trial is for individuals with knee osteoarthritis who meet the American College of Rheumatology criteria. It's not suitable for those with severe sensory impairments, cognitive issues that affect consent or assessments, scheduled joint replacements, open wounds on the knee, inability to follow study procedures, unstable medical conditions like uncontrolled diabetes or heart problems, history of total knee arthroplasty with pain only in the operated knee, untreated severe bleeding disorders or serious psychiatric conditions.Check my eligibility
What is being tested?
The trial tests several non-surgical treatments to manage long-term pain and improve function in people with knee osteoarthritis. Treatments include Duloxetine (a medication), nerve procedures using either long-acting blocks or ablation techniques (nerve destruction), best practice care strategies, intra-articular injections (directly into the joint), and training to develop skills for coping with pain.See study design
What are the potential side effects?
Potential side effects may include discomfort at injection sites from intra-articular injections; skin irritation or numbness from nerve procedures; digestive issues, fatigue, mood changes from Duloxetine; and general risks associated with any medical procedure such as infection.
SKOAP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~opioid use and pain assessed up to 2 years. pgic assessed at main outcome visit (8 and 12 weeks for phase 1 and phase 2, respectively). the treatment response categorical outcome will be analyzed separately for mitt and per- protocol analyses.
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Pain Intensity as assessed by the Modified 4-item Brief Pain Inventory (BPI) Pain Scale
Secondary outcome measures
Change in Pain Intensity as assessed by the BPI
Change in Pain Interference as assessed by the BPI
Change in Physical Functioning as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
+5 moreSKOAP Trial Design
6Treatment groups
Active Control
Group I: Phase 1:Best Practices + Duloxetine + Pain coping skillsActive Control3 Interventions
Participants will receive Duloxetine, pain coping skills training, and a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments.
Group II: Phase 1: Best Practices + DuloxetineActive Control2 Interventions
Participants will receive Duloxetine and a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments.
Group III: Phase 1: Best PracticesActive Control1 Intervention
Participants will receive a prescription for guideline-recommended treatments for knee osteoarthritis, i.e., Best Practices. Best Practices can include topical or oral nonsteroidal anti-inflammatory drugs (NSAIDs), acetaminophen; physical therapy that may include aquatherapy; integrative treatments such as acupuncture, yoga, or a structured exercise program; and other non-invasive treatments.
Following the Phase 1 interim analysis in November 2023, the Data Safety and Monitoring Board and study sponsors approved formal closure of this arm per the pre-specified stopping rules.
Group IV: Phase 2: Intra-Articular Injection (HA+)Active Control1 Intervention
Participants will receive an intra-articular injection of hyaluronic acid mixed with steroid and bupivacaine.
Group V: Phase 2: Nerve Procedure: Long Acting BlocksActive Control1 Intervention
Participants will receive a nerve blocking procedure, long-acting local anesthetic, and steroid injection.
Group VI: Phase 2: Nerve Procedure: Nerve AblationActive Control1 Intervention
Participants will receive a nerve ablation procedure and steroid injection.
Find a Location
Who is running the clinical trial?
Johns Hopkins UniversityLead Sponsor
2,260 Previous Clinical Trials
14,818,980 Total Patients Enrolled
9 Trials studying Osteoarthritis
834 Patients Enrolled for Osteoarthritis
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)NIH
484 Previous Clinical Trials
1,085,207 Total Patients Enrolled
50 Trials studying Osteoarthritis
45,181 Patients Enrolled for Osteoarthritis
Steven Cohen, MDPrincipal InvestigatorJohns Hopkins University
11 Previous Clinical Trials
1,164 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any severe health conditions that would make it unsafe for me to participate.I am scheduled for a knee replacement surgery.I have an ulcer or open wound near my knee.You are currently using drugs or alcohol in a way that is harmful or addictive.I have had knee replacement surgery and feel pain in that knee.I do not have an untreated severe bleeding disorder.I have a serious mental health condition that is not well-managed.
Research Study Groups:
This trial has the following groups:- Group 1: Phase 1:Best Practices + Duloxetine + Pain coping skills
- Group 2: Phase 1: Best Practices + Duloxetine
- Group 3: Phase 1: Best Practices
- Group 4: Phase 2: Intra-Articular Injection (HA+)
- Group 5: Phase 2: Nerve Procedure: Long Acting Blocks
- Group 6: Phase 2: Nerve Procedure: Nerve Ablation
Awards:
This trial has 2 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Osteoarthritis Patient Testimony for trial: Trial Name: NCT04504812 — Phase 3
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many patients will be treated with this new medication?
"To move this study forward, we need 2700 participants that fit the bill in terms of our specified inclusion criteria. Patients can come from various locations, such as Brigham and Women's Hospital in Boston, Massachusetts and Johns Hopkins in Baltimore, Maryland."
Answered by AI
Can I enroll in this clinical trial?
"Osteoarthritis patients that also have knee pain and are between 18 and 90 years old are good candidates for this clinical trial, of which there are 2700 total slots."
Answered by AI
Have there been any other research projects that explore similar methods for managing pain?
"Right now, there are 4 Phase 3 and 26 Phase 1 clinical trials ongoing for the combination of duloxetine and pain coping skills. Most of the Phase 1 trials are taking place in Redwood City, California, but there are a total of 786 research sites for this phase of the study."
Answered by AI
In how many different cities is this trial being run?
"patients can enroll in this study at Brigham and Women's Hospital in Boston, Johns Hopkins in Baltimore, the University of California San Diego in San Diego, or one of the 17 other sites."
Answered by AI
Are there any empty slots in this research project that patients could fill?
"That is accurate. The clinical trial is currently recruiting patients, with the first posting on February 1st, 2021 and the most recent update on August 29th, 2022. There are 1700 patients needed for the trial, which will be conducted at 17 different locations."
Answered by AI
Does the age limit for this research extend to people over 65 years old?
"The age limit for this particular trial is 18-90. However, there are other studies with different age brackets. For those under 18, there are 39 studies, and for patients over the age of 65, there are 701 studies."
Answered by AI
What psychological and physical ailments does Phase 1:Best Practices + Duloxetine + Pain coping skills typically address?
"Duloxetine in combination with best practices and pain coping skills is most often used to treat diabetic peripheral neuropathy. However, this phase 1 treatment can also be used to ameliorate other conditions such as knee pain, major depressive disorder, and disorders of the musculoskeletal system."
Answered by AI
Has the FDA cleared Phase 1:Best Practices + Duloxetine + Pain coping skills for use?
"Given that this is a Phase 3 trial with evidence of efficacy and multiple rounds of data supporting safety, our team rates the safety of Phase 1:Best Practices + Duloxetine + Pain coping skills as a 3."
Answered by AI
Who else is applying?
What state do they live in?
Oregon
Washington
Other
Maryland
How old are they?
65+
18 - 65
What site did they apply to?
Johns Hopkins
University of California San Diego
University of Washington
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
2
3+
0
Why did patients apply to this trial?
i havent tried any drugs. The constant discomfort is to much. I have severe osteoarthritis in my left knee and right hip.
PatientReceived 2+ prior treatments
I've has TKR of rt.knee and want to avoid it in my left knee. I would like to get relief from pain and swelling of my right knee.
PatientReceived no prior treatments
What questions have other patients asked about this trial?
What sort of screening and/or diagnosis is required prior to acceptance?
PatientReceived 1 prior treatment
How responsive is this trial?
Typically responds via
Phone Call
Email
Most responsive sites:
- Oregon Health and Science University: < 48 hours
- Johns Hopkins: < 48 hours
Average response time
- < 2 Days
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