Osteoarthritis Bedside Testing Kit

Status unconfirmed

Conditions studied: Osteoarthritis

In brief

Develop and test a bedside testing kit for evaluating pain and symptoms of osteoarthritis

Key facts

Study ID

NCT00794651

Run by

Analgesic Solutions

People needed

25

Starts

2009-01-01

Expected to finish

2009-06-01

Last updated by the study team

2008-11-20

Who can join

Age: 50 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• • 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.

Where it is running

• Analgesic Research, LLC — Needham, Massachusetts, United States

Full record on ClinicalTrials.gov

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