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A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain (SKOAP)

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ClinicalTrials.gov Identifier: NCT04504812
Recruitment Status : Recruiting
First Posted : August 7, 2020
Last Update Posted : May 5, 2021
Sponsor:
Collaborator:
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE August 5, 2020
First Posted Date  ICMJE August 7, 2020
Last Update Posted Date May 5, 2021
Actual Study Start Date  ICMJE February 1, 2021
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
Change in Pain Intensity as assessed by the Brief Pain Inventory (BPI) [ Time Frame: Baseline and 8 weeks post-treatment for Phase 1; Baseline and 12 weeks post-treatment for Phase 2 ]
The BPI Pain Intensity domain is a continuous measure and will be calculated as the average of worst, least, average, and current knee pain as the primary outcome. BPI scores range from 0-10 with higher scores reflecting more pain.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 6, 2020)
  • Change in Pain Interference as assessed by the BPI [ Time Frame: Baseline and 8 weeks post-treatment for Phase 1; Baseline and 12 weeks post-treatment for Phase 2 ]
    The BPI Pain Interference domain assesses self-reported consequences of pain on relevant aspects of one's life. The BPI measures how much pain has interfered with seven daily activities, including general activity, walking, work, mood, enjoyment of life, relations with others, and sleep. BPI pain interference is typically scored as the mean of the seven interference items. BPI Interference ranges from 0-10 with higher scores reflecting greater pain interference in activities of daily living.
  • Change in Physical Functioning as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS) [ Time Frame: Baseline and 8 weeks post-treatment for Phase 1; Baseline and 12 weeks post-treatment for Phase 2 ]
    The KOOS evaluates function for participants with osteoarthritis of the knee that is related to injury and degeneration. The KOOS short form includes 12 items and measures pain, functional limitation and quality of life. Physical functioning questions cover everyday activities such as rising from sitting, standing getting in and out of the car and twisting/pivoting on the knee. Scores range from 0-100 with lower scores indicating worse knee symptoms.
  • Patient Global impression of Change (PGIC) [ Time Frame: At 8 weeks post-treatment for Phase 1; At 12 weeks post-treatment for Phase 2 ]
    The PGIC scale evaluates all aspects of participants' health and assesses if there has been an improvement or decline in clinical status. It is a 7-item scale that ranges between "a great deal worse" to "a great deal better." Higher scores reflect greater improvement in clinical status.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain
Official Title  ICMJE A Sequenced Strategy for Improving Outcomes in People With Knee Osteoarthritis Pain
Brief Summary There is an urgent public health need to reduce reliance on opioids for effective long-term pain management, particularly in knee osteoarthritis (KOA). This effectiveness trial will compare commonly recommended treatments to reduce pain and functional limitations in KOA.These results will lead to improved patient selection for treatment and inform evidence based guidelines by offering well-tested, effective, non-surgical alternatives.
Detailed Description Knee osteoarthritis (KOA) is one of the leading causes of chronic pain and disability worldwide, affecting over 30% of older adults. It represents a major global health and economic burden to individuals and society. The rates of KOA have more than doubled in the past 70 years and continue to grow sharply, given increases in life expectancy and population body mass index (BMI). Surgery is often employed to treat KOA, but it is associated with a high rate of persistent pain, and is not a permanent solution. Numerous nonsurgical therapies have been advocated to treat pain in patients with KOA yet are not often used in clinical care. The limited pain relief and functional improvement seen in a subset of knee OA sufferers has led to a high rate of opioid use and disability in this population. The overarching goal of this study is to conduct a sequential parallel group randomized controlled trial (RCT) to evaluate the comparative effectiveness of conservative behavioral and non-opioid pharmacological treatments (Phase 1) and, among those that indicate interest in obtaining further treatment and those not eligible for conservative treatment, the benefits of procedural interventions (Phase 2). This study will also evaluate whether clinical and psychosocial phenotypes predict short- and longer-term treatment response. The results of this study will examine the effectiveness of each tested intervention and provide meaningful information regarding effectiveness across key subgroups of participants.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Sequential Assignment
Intervention Model Description:
Using a stepped care model, Phase 1 participants will be randomly assigned to minimally invasive treatments, including best practices, best practices plus duloxetine, and best practices plus duloxetine combined with a web-based pain coping skills training program. Those who note interest in additional treatment following completion of Phase 1, as well as those that are not eligible for Phase 1 treatment, will be randomly assigned to more aggressive procedures: intra-articular hyaluronic acid, steroid and local anesthetic injection, or a nerve procedure that would either include a long acting block or nerve ablation.
Masking: Single (Participant)
Masking Description:
Individuals randomized to a nerve procedure will be blinded to whether they have a long acting block or nerve ablation.
Primary Purpose: Treatment
Condition  ICMJE Knee Osteoarthrosis
Intervention  ICMJE
  • Drug: Duloxetine
    Duloxetine is a drug that is used to improve pain and function in people with knee osteoarthritis (KOA). Duloxetine is approved by the Food and Drug Administration (FDA) for the treatment of depression, anxiety disorder, fibromyalgia, and joint pain. It will be titrated up from 20 or 30mg according to a schedule provided by a study provider.
    Other Name: Cymbalta
  • Combination Product: Intra-Articular Injection
    Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1mL depo methylprednisolone (a steroid) and 2mL 0.5% bupivacaine (an anesthetic) into the knee.
  • Procedure: Nerve Procedure with long acting blocks
    People assigned to receive this will have 1mL of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) injected into the knee.
  • Procedure: Nerve Procedure with nerve ablation
    People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee.
  • Behavioral: Pain Coping Skills Training
    Participants will be provided with a written manual that includes login information for the pain coping skills training website. They will be expected to log into the system weekly, work through the modules, and participate in skills practice. This intervention will be conducted in combination with best practices and duloxetine.
  • Other: Best Practices
    Best Practice includes treatments that experts recommend for knee arthritis pain. Best Practice can include topical or oral pain relievers, a structured exercise program, and weight management if BMI is over 30. Other non-invasive treatments such as acupuncture and yoga are also included.
Study Arms  ICMJE
  • Active Comparator: Phase 1: Best Practices
    Participants will receive an intervention from the best practices.
    Intervention: Other: Best Practices
  • Active Comparator: Phase 1: Best Practices + Duloxetine
    Participants will receive Duloxetine in addition to an intervention from the best practices.
    Interventions:
    • Drug: Duloxetine
    • Other: Best Practices
  • Active Comparator: Phase 1:Best Practices + Duloxetine + Pain coping skills
    Participants will receive Duloxetine and pain coping skills training in addition to an intervention from the best practices.
    Interventions:
    • Drug: Duloxetine
    • Behavioral: Pain Coping Skills Training
    • Other: Best Practices
  • Active Comparator: Phase 2: Intra-Articular Injection (HA+)
    Participants will receive an intra-articular injection.
    Intervention: Combination Product: Intra-Articular Injection
  • Active Comparator: Phase 2: Nerve Procedure: Long Acting Blocks
    Participants will receive a nerve blocking procedure.
    Intervention: Procedure: Nerve Procedure with long acting blocks
  • Active Comparator: Phase 2: Nerve Procedure: Nerve Ablation
    Participants will receive a nerve ablation procedure.
    Intervention: Procedure: Nerve Procedure with nerve ablation
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 6, 2020)
2700
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 2024
Estimated Primary Completion Date August 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Meets American College of Rheumatology Classification criteria for knee osteoarthritis

Exclusion Criteria:

  • Any inability to complete study procedures, including, but not limited to low English language literacy.
  • Inability to access the internet on a daily basis
  • Unstable medical condition that presents as an absolute or relative contraindication for participation (e.g., unstable angina, poorly controlled diabetes mellitus, end stage renal failure, automated implantable cardioverter-defibrillator that cannot be disabled before RFA).
  • Severe untreated bleeding disorder (anticoagulants may be continued during phase II treatments in most patients)
  • Severe vision or hearing impairment or serious cognitive impairment that could interfere with consent or outcome assessment
  • Poorly controlled serious psychiatric condition
  • Active substance abuse
  • Scheduled joint replacement on the affected knee
  • History of unilateral total knee arthroplasty (TKA) with complaints of KOA pain limited to the operated knee
  • Ulcers or an open wound in the region of the index knee
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 90 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Claudia Campbell, PhD 888-304-0711 ccampb41@jhmi.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04504812
Other Study ID Numbers  ICMJE IRB00238678
1UG3AR077360-01 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: After last subject enrollment and all follow up procedures have been completed, the Helping to End Addiction Long-Term (HEAL) Pain Management Effectiveness Research Network Data Coordinating Center at the University of Utah will prepare a final study database for the trial, which will then be used for statistical analyses and publication of findings from the trial.The Trial will provide a resource of data concerning methods for managing pain and reducing opioid addiction, and the Data Coordinating Center (DCC) will produce a database that can be used by non- Effectiveness Research Network (ERN) investigators.The DCC will also prepare a data dictionary that provides a concise definition of every data element included in the database. If specific data elements have idiosyncrasies that might affect interpretation or analysis, this will be discussed in the dictionary document. Data elements that are considered unreliable will be deleted, and this will be noted in the documentation.
Time Frame: These policies are expected to focus primarily on the timing of data release. The investigator's preliminary plan is to release the database (defined below) at the time of publication of the primary manuscript, or within 12 months of last patient procedure, whichever comes first. Implementation of the plan will follow the HEAL Public Access and Data Sharing Policy as outlined at https://heal.nih.gov/about/public-access-data
Access Criteria: Access to the releasable database housed in the NIH-assigned repository will be in accordance with procedures and regulations of the NIH or specific institute. The data coordinating center will not provide any support for investigators using the releasable database.
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Investigators  ICMJE
Principal Investigator: Steven Cohen, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP