Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
25 participants
OBSERVATIONAL
2009-01-31
2009-06-30
Brief Summary
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Detailed Description
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Conduct a reliability and usability study with subjects with painful osteoarthritis of the knee to determine Intra-rater reliability, Inter-rater reliability, Kit reliability.
Conditions
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Keywords
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Study Design
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PROSPECTIVE
Study Groups
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OA
moderate to severe osteoarthritis of the knee
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Subject is able to communicate meaningfully in English and comply with all study procedures.
* Subject is willing to voluntarily sign and date an informed consent form, approved by an Institutional Review Board (IRB)/Independent Ethics Committee (IEC), prior to the conduct of any study-specific procedures.
* Subject has experienced a minimum duration of pain of at least 6 months.
* For each of the last 15 days, pain level has remained at least a 3 on a Pain Intensity Numerical Rating (P-NRS) scale from 0 to 10; 0 means "no pain" and 10 means "worst pain imaginable".
* Subject is ambulatory.
* Subject has a primary diagnosis of osteoarthritis of the knee by medical history.
* Subject must be willing to abstain from any pain medicine for 12 hours prior to the study.
Exclusion Criteria
* Subject has a medical condition, other than OA, that is not well-controlled with treatment; or the subject has any clinically significant condition that would, in the opinion of the investigator, preclude study participation or interfere with the assessment of pain and other symptoms of OA.
* Subject is not able to hold a stylus or pen.
* Subject is not able to read a computer screen.
* Subject has any chronic pain syndrome (e.g., fibromyalgia) that, in the investigator's opinion, would interfere with the assessment of pain and/or other symptoms of OA.
* In the judgment of the investigator, the subject has a psychiatric or psychological disorder that would interfere with the completion of the study, confound the study results or pose patient risk.
50 Years
85 Years
ALL
No
Sponsors
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Analgesic Solutions
INDUSTRY
Responsible Party
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Analgesic Research, LLC
Principal Investigators
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Nathaniel Katz, MD
Role: PRINCIPAL_INVESTIGATOR
Analgesic Research
Thomas A Eaton, PhD
Role: STUDY_DIRECTOR
Analgesic Research
Locations
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Analgesic Research, LLC
Needham, Massachusetts, United States
Countries
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Central Contacts
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Facility Contacts
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Thomas A Eaton, PhD
Role: primary
Other Identifiers
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AR_08_MK_01
Identifier Type: -
Identifier Source: org_study_id