Osteoarthritis Bedside Testing Kit

The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Analgesic Solutions.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by:
Analgesic Solutions
ClinicalTrials.gov Identifier:
NCT00794651
First received: November 19, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  Purpose

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


Condition
Osteoarthritis

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis

Resource links provided by NLM:


Further study details as provided by Analgesic Solutions:

Estimated Enrollment: 25
Study Start Date: January 2009
Estimated Study Completion Date: June 2009
Estimated Primary Completion Date: May 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts
OA
moderate to severe osteoarthritis of the knee

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.

  Eligibility

Ages Eligible for Study:   50 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

moderate to severe osteoarthritis of the knee .

Criteria

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.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00794651

Contacts
Contact: Thomas A Eaton, PhD 781-444-9605 teaton@analgesicresearch.com

Locations
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
Investigators
Principal Investigator: Nathaniel Katz, MD Analgesic Research
Study Director: Thomas A Eaton, PhD Analgesic Research
  More Information

No publications provided

Responsible Party: Nathaniel Katz, MD, Analgesic Research, LLC
ClinicalTrials.gov Identifier: NCT00794651     History of Changes
Other Study ID Numbers: AR_08_MK_01
Study First Received: November 19, 2008
Last Updated: November 19, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by Analgesic Solutions:
osteoarthritis
testing kit
knee

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on July 24, 2014