We updated the design of this site on December 18, 2017. Learn more.
ClinicalTrials.gov Menu

Osteoarthritis Bedside Testing Kit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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
Information provided by:
Analgesic Solutions

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

Condition or disease

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, 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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

moderate to severe osteoarthritis of the knee

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   50 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
moderate to severe osteoarthritis of the knee .

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:

  • • 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.

Information from the National Library of Medicine

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      
Sponsors and Collaborators
Analgesic Solutions
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

Keywords provided by Analgesic Solutions:
testing kit

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases