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

March 7, 2024 updated by: Johns Hopkins University
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Estimated)

1800

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • California
      • Sacramento, California, United States, 95817
        • Recruiting
        • University of California Davis
        • Contact:
      • San Diego, California, United States, 92037
        • Recruiting
        • University of California San Diego
        • Contact:
          • Research Coordinator
          • Phone Number: 858-822-3108
      • San Diego, California, United States, 92161
        • Recruiting
        • VA Medical Center San Diego
        • Contact:
          • Research Coordinator
          • Phone Number: 2969 858-552-8585
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Florida
      • Gainesville, Florida, United States, 32608
        • Recruiting
        • University of Florida
        • Contact:
    • Georgia
      • Atlanta, Georgia, United States, 30322
        • Recruiting
        • Emory University
        • Contact:
          • Research Coordinator
          • Phone Number: 404-251-0759
      • Decatur, Georgia, United States, 30033
        • Recruiting
        • Atlanta VA Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 404-245-1202
    • Illinois
      • Chicago, Illinois, United States, 60611
    • Iowa
      • Iowa City, Iowa, United States, 52242
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Recruiting
        • Johns Hopkins
        • Contact:
        • Contact:
          • Phone Number: 410-550-7906
      • Bethesda, Maryland, United States, 20889
        • Recruiting
        • Walter Reed Army Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 301-295-0261
    • Massachusetts
      • Boston, Massachusetts, United States, 02199
        • Recruiting
        • Brigham and Women's Hospital
        • Contact:
          • Research Coordinator
          • Phone Number: 617-732-9463
    • Minnesota
      • Minneapolis, Minnesota, United States, 55455
        • Recruiting
        • University of Minnesota
        • Contact:
    • New York
      • New York, New York, United States, 10019
        • Recruiting
        • Weill Cornell University
        • Contact:
          • Research Coordinator
          • Phone Number: 212-746-9419
      • Rochester, New York, United States, 14623
        • Recruiting
        • University of Rochester Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 585-953-4933
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina
        • Contact:
      • Winston-Salem, North Carolina, United States, 27517
        • Recruiting
        • Wake Forest University
        • Contact:
          • Research Coordinator
          • Phone Number: 336-716-8791
    • Ohio
      • Cleveland, Ohio, United States, 44106
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland VA Medical Center
        • Contact:
          • Research Coordinator
          • Phone Number: 65418 216-791-3800
    • Oregon
      • Portland, Oregon, United States, 97239
        • Recruiting
        • Oregon Health and Science University
        • Contact:
          • Research Coordinator
          • Phone Number: 503-494-2180
    • Tennessee
      • Nashville, Tennessee, United States, 37232
    • Utah
      • Salt Lake City, Utah, United States, 84108
        • Recruiting
        • University of Utah
        • Contact:
          • Research Coordinator
          • Phone Number: 801-585-7697
    • Virginia
      • Charlottesville, Virginia, United States, 22908
    • Washington
      • Seattle, Washington, United States, 98185
        • Recruiting
        • University of Washington
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 88 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Knee pain score of ≥4 and ≤ 9 on the Modified 4-Item BPI Pain Scale at pre-intervention screening
  • Meets at least 1 of the 3 American College of Rheumatology (ACR) Classification criteria for knee osteoarthritis.

ACR criteria are:

  1. At least three of the following using history and physical examination: age >50 years old; morning stiffness <30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth
  2. At least one of the following using history, physical examination, and radiographic findings + the presence of osteophytes: age >50 years old; morning stiffness <30 minutes; crepitus on active motion and osteophytes
  3. At least 5 of the following using history, physical examination, and laboratory findings: age >50 years old; morning stiffness <30 minutes; crepitus on knee motion; bony tenderness; bony enlargement; no palpable warmth; erythrocyte sedimentation rate (ESR) <40 mm/hour; Rheumatoid Factor (RF) <1:40; synovial fluid signs of osteoarthritis

Exclusion Criteria:

  • <18 years of age
  • Any inability to complete study procedures, including, but not limited to inadequate resources to mitigate low English language literacy
  • Refusal of randomization
  • Knee pain exclusions: Pain during an average of < 4 days per week over the past 3 months; pain in the index knee from a joint disease other than OA (e.g., infectious arthritis, rheumatoid arthritis, spondyloarthropathy)
  • Medication exclusions: Report changes in analgesic medication dose within 2 weeks of baseline; oral morphine equivalent dose of > 90 mg/d at baseline
  • Medical condition exclusions: Severe vision or hearing impairment or any signs of cognitive impairment that would prevent comprehension of consent procedures, study measures, or procedures; unstable medical condition that presents an absolute or relative contraindication for participation in both arms (e.g., unstable angina, congestive heart failure); poorly controlled serious psychiatric condition that could prevent full participation or affect outcomes (e.g., suicidal ideation, active psychosis, poorly controlled depression, active substance abuse [excluding tobacco, caffeine or moderate alcohol use])
  • Knee-specific medical condition exclusions: History of bilateral knee joint replacement arthroplasty total knee arthroplasty (TKA) or TKA in the affected knee; partial replacements may be eligible depending on physician judgment; scheduled joint replacement; history of unilateral TKA and complaints of KOA pain limited to the operated knee; Intra-articular viscosupplementation, steroid injection or arthroscopic surgery in the index knee within 12 weeks of baseline
  • Pregnancy by self-report, report of intention to become pregnant (Phase 1), or as determined by urine pregnancy screening (if Standard of Care at site) (Phase 2). Due to the unknown effects of duloxetine on the developing fetus and newborn, and the potential harms of fluoroscopy in pregnancy, women who are pregnant or lactating or intend to get pregnant will not be included in this study. Those of childbearing potential will be asked to use reliable contraception during the course of their participation in the study and to notify the study team if they become pregnant during participation. Definition of reliable birth control will be defined as: Female and male sterilization (female tubal ligation or occlusion, male vasectomy); long-acting reversible contraceptives (LARC) methods (intrauterine devices, hormonal implants); short-acting hormonal methods (pill, mini pills, patch, shot, vaginal ring); barrier methods (condoms, diaphragms, sponge, cervical cap)

Phase 1 specific Exclusion Criteria- An individual who meets any of the following criteria will be excluded from participation in Phase 1 of this study and will be enrolled and randomized directly into Phase 2:

  • Known allergic reaction or medical condition that renders an individual unsuitable for Phase 1 study interventions, including closed-angle glaucoma, kidney disease (creatinine clearance < 30 mL/ min), severe liver disease, known adverse reaction to duloxetine or another selective serotonin-norepinephrine reuptake inhibitor (SNRI), bipolar disorder or mania, high likelihood of drug interactions that could lead to side effects (e.g., serotonin syndrome in people on multiple drugs that inhibit serotonin reuptake including monoamine oxidase (MAO) inhibitors).
  • Report failed trial of an adequate dose of duloxetine to relieve KOA symptoms over a 1-month period
  • Have tried and failed two of the following: NSAIDS, physical therapy (there are many physical therapies so clinicians should exercise their judgment as to what constitutes 'failed' therapy), or weight loss (need determined by clinician) and refuses participation in Phase 1
  • End-stage renal disease
  • Unreliable access to the internet on a daily basis, i.e., sufficient access to participate in the study and may include public library access, cafe/coffee shop spaces, access to a friend or neighbor's wifi or hotspot, etc. (reliability determined on a site-by-site basis)

Phase 2 specific exclusion criteria- An individual who meets any of the following is excluded from sequential participation in Phase 1 and then Phase 2, and will instead be randomized as a "solo" recruit into Phase 1:

  • Inability to pay for interventions (insurance or otherwise)
  • Medical condition exclusions: Untreated coagulopathy that could interfere with Phase 2 interventions; for automated implantable cardioverter-defibrillator that cannot be disabled before radiofrequency ablation (RFA), the investigator can consult cardiology, bioengineering or the device manufacturer before enrolling in phase 2 (i.e. not a definite exclusion criterion)
  • Knee specific medical condition exclusions: Current local infection in the knee; ulcers or an open wound in the region of the index knee; underwent an adequate trial of any Phase 2 procedural study intervention in the study knee; severe needle phobia that cannot be addressed pharmacologically

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Phase 2: Intra-Articular Injection (HA+)
Participants will receive an intra-articular injection of hyaluronic acid mixed with steroid and bupivacaine.
Combination product: Intra-Articular Injection
Intra-Articular Injection is an injection of 3-6 milliliter (mL) hyaluronic acid (HA) mixed with 1 milliliter (mL) depo methylprednisolone (a steroid) and 2 mL 0.5% bupivacaine (an anesthetic) into the knee.
Active Comparator: Phase 2: Nerve Procedure: Long Acting Blocks
Participants will receive a nerve blocking procedure, long-acting local anesthetic, and steroid injection.
Procedure: Nerve Procedure with long acting blocks
People assigned to receive this will have 1 milliliter (mL) of a long-acting local anesthetic (a.k.a. liposomal bupivacaine or EXPAREL) and steroid injected into the knee.
Active Comparator: Phase 2: Nerve Procedure: Nerve Ablation
Participants will receive a nerve ablation procedure and steroid injection.
Procedure: Nerve Procedure with nerve ablation
People assigned to receive this will have heat applied to destroy the nerve signaling pain in the knee. Steroid will be administered after the procedure to reduce the risk of neuritis.
Active Comparator: Phase 1: Best Practices + Duloxetine
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.
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 Names:
  • Cymbalta
Other: 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.
Active Comparator: Phase 1:Best Practices + Duloxetine + Pain coping skills
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.
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 Names:
  • Cymbalta
Other: 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.
Behavioral: Pain Coping Skills Training
Participants will be provided with a written manual that includes login information for the pain coping skills training website. The participants 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.
Active Comparator: Phase 1: Best Practices

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.
Other: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Intensity as assessed by the Modified 4-item Brief Pain Inventory (BPI) Pain Scale
Time Frame: Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2
The Modified 4-item BPI Pain scale consists of 3 items from BPI Pain Intensity and 1 item from BPI Pain Interference. This is a continuous measure that will be calculated as the average of worst, average, current knee pain, and pain upon walking. Change from baseline (BL) will be used in mITT analyses, and change from treatment will be used in per protocol analyses.
Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pain Interference as assessed by the BPI
Time Frame: Change from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in 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 from Baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2
Change in Physical Functioning as assessed by the Knee Injury and Osteoarthritis Outcome Score (KOOS)
Time Frame: Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in 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.
Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from Baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2
Patient Global impression of Change (PGIC)
Time Frame: 8 weeks post-randomization (mITT) and 8 weeks post-treatment (per protocol) in Phase 1; 12 weeks post-randomization (mITT) and 12 weeks post-treatment (per protocol) in 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.
8 weeks post-randomization (mITT) and 8 weeks post-treatment (per protocol) in Phase 1; 12 weeks post-randomization (mITT) and 12 weeks post-treatment (per protocol) in Phase 2
Change in Pain Intensity as assessed by the BPI
Time Frame: Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in 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 from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2
Compare Morphine Milligram Equivalent (MME) doses
Time Frame: Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2
Participants will be queried regarding their analgesic use over the past week (for all participants including those prescribed an opioid/other analgesic from non-study providers) to determine morphine equivalents. Adherence to prescription medication instructions will be monitored by self-report. This outcome will be applicable to: Phase 1- participants prescribed opioids prior to study initiation; Phase 2- participants prescribed opioids prior to study initiation and those who receive an opioid prescription from a study clinician during the course of the study or longer-term follow-up.
Change from baseline to 8 weeks post-randomization (mITT) and to 8 weeks post-treatment (per protocol) in Phase 1; Change from baseline to 12 weeks post-randomization (mITT) and to 12 weeks post-treatment (per protocol) in Phase 2
Time to receipt of additional treatment for to KOA
Time Frame: Up to 2 years
Healthcare utilization will be measured as it relates to KOA on an ongoing basis throughout the study
Up to 2 years
Treatment response as a binary outcome for Phase 1 and 2 intervention arms using the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials (IMMPACT) guidelines
Time Frame: Opioid use and pain are measured at all follow-up time points and will be used through Phase1: 8 weeks post-rand. and 8 weeks post-treatment; Phase 2: 12 weeks post-rand. and 8 weeks post-treatment

BPI intensity will be measured, per IMMPACT cut off guidelines and will also incorporate changes in opioid dose. A 20% decrease in pain intensity is minimally important, ⩾30% moderately important and ⩾50% substantial. Each of these brackets will be evaluated to determine responders at the pain criteria cut points.

Despite meeting guideline criteria, anyone meeting the following will not be considered a treatment responder:

  1. Increase in new opioid use of >15 morphine milligram equivalents (MME) or;
  2. Increase of >100mg Tramadol
Opioid use and pain are measured at all follow-up time points and will be used through Phase1: 8 weeks post-rand. and 8 weeks post-treatment; Phase 2: 12 weeks post-rand. and 8 weeks post-treatment
Treatment response as a binary outcome for Phase 1 and 2 intervention arms based on OARSI-OMERACT guidelines, incorporating changes in opioid dose.
Time Frame: 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.

BPI intensity, KOOS, PGIC and opioid use will be measured, and define a categorical outcome based on Osteoarthritis Research Society International (OARSI) Standing Committee for Clinical Trials Response Criteria Initiative and the Outcome Measures in Rheumatology (OARSI-OMERACT) guidelines (pain, function measures, and patient assessment), incorporating changes in opioid dose.

A treatment responder will be defined as either:

High improvement in pain or in function ≥50% and absolute change of >2 for BPI and ≥20 for KOOS,

Or

Improvement in at least 2 of the 3 following:

  • pain ≥20% and absolute change of >1
  • function ≥20% and absolute change ≥10
  • patient's global impression of change ≥minimal improvement

Despite meeting guideline criteria, anyone meeting the following will not be considered a treatment responder:

  1. Increase in new opioid use of >15 morphine milligram equivalents (MME) or;
  2. Increase of >100mg Tramadol
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Johns Hopkins University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Investigators

  • Principal Investigator: Steven Cohen, MD, Johns Hopkins University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 1, 2021

Primary Completion (Estimated)

November 1, 2024

Study Completion (Estimated)

March 31, 2025

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 6, 2020

First Posted (Actual)

August 7, 2020

Study Record Updates

Last Update Posted (Actual)

March 12, 2024

Last Update Submitted That Met QC Criteria

March 7, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB00238678
  • 1UG3AR077360-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Upon completing data collection, specifically after the last patient's main outcome visit (excluding long-term follow-up), the HEAL Pain Management Effectiveness Research Network (ERN) Data Coordinating Center (DCC) at the University of Utah will compile the final study dataset. This dataset will undergo statistical analyses and form the basis for publishing both primary and secondary trial results. The SKOAP dataset, recognized as valuable for pain management and opioid use research communities, will be formatted for accessibility to non-ERN investigators. Additionally, a data dictionary will accompany the dataset, offering concise definitions for each included data element. Any peculiarities impacting interpretation or analysis will be outlined within the dictionary. Unreliable data elements will be removed, with documentation provided accordingly.

IPD Sharing Time Frame

These policies are expected to focus primarily on the timing of data release. The investigators preliminary plan is to release the database (defined below) and supporting information at the time of publication of the primary manuscript, or within 12 months of last patient's final follow-up, 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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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