Osteoarthritis Bedside Testing Kit
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ClinicalTrials.gov Identifier: NCT00794651 |
Recruitment Status : Unknown
Verified November 2008 by Analgesic Solutions.
Recruitment status was: Not yet recruiting
First Posted : November 20, 2008
Last Update Posted : November 20, 2008
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Condition or disease |
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Osteoarthritis |
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, appropriateness of the data capture, simplicity, subject and investigator burden, and overall impressions of the procedures.
Conduct a reliability and usability study with subjects with painful osteoarthritis of the knee to determine Intra-rater reliability, Inter-rater reliability, Kit reliability.
Study Type : | Observational |
Estimated Enrollment : | 25 participants |
Time Perspective: | Prospective |
Official Title: | Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis |
Study Start Date : | January 2009 |
Estimated Primary Completion Date : | May 2009 |
Estimated Study Completion Date : | June 2009 |

Group/Cohort |
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OA
moderate to severe osteoarthritis of the knee
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Ages Eligible for Study: | 50 Years to 85 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
- 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 Criteria:
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• 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00794651
Contact: Thomas A Eaton, PhD | 781-444-9605 | teaton@analgesicresearch.com |
United States, Massachusetts | |
Analgesic Research, LLC | Not yet recruiting |
Needham, Massachusetts, United States, 02494 | |
Contact: Thomas A Eaton, PhD 781-444-9605 |
Principal Investigator: | Nathaniel Katz, MD | Analgesic Research | |
Study Director: | Thomas A Eaton, PhD | Analgesic Research |
Responsible Party: | Nathaniel Katz, MD, Analgesic Research, LLC |
ClinicalTrials.gov Identifier: | NCT00794651 History of Changes |
Other Study ID Numbers: |
AR_08_MK_01 |
First Posted: | November 20, 2008 Key Record Dates |
Last Update Posted: | November 20, 2008 |
Last Verified: | November 2008 |
osteoarthritis testing kit knee |
Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases |