Status:
UNKNOWN
Osteoarthritis Bedside Testing Kit
Lead Sponsor:
Analgesic Solutions
Conditions:
Osteoarthritis
Eligibility:
All Genders
50-85 years
Brief Summary
Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis
Detailed Description
Conduct a Focus group of subjects with painful osteoarthritis of the knee to evaluate potential kit for acceptability to subjects and investigators, and usability, clarity of instructions, appropriate...
Eligibility Criteria
Inclusion
- Subject is 50 years of age or older and has osteoarthritis of the knee.
- 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
- • Subject is pregnant and/or breast-feeding.
- 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.
Key Trial Info
Start Date :
January 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
June 1 2009
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT00794651
Start Date
January 1 2009
End Date
June 1 2009
Last Update
November 20 2008
Active Locations (1)
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1
Analgesic Research, LLC
Needham, Massachusetts, United States, 02494