Osteoarthritis Bedside Testing Kit

November 19, 2008 updated by: Analgesic Solutions

Development of a Bedside Pain Assessment Kit for Evaluating Effectiveness of Drugs for Osteoarthritis

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

Study Overview

Status

Unknown

Conditions

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

Enrollment (Anticipated)

25

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • Massachusetts
      • Needham, Massachusetts, United States, 02494
        • Analgesic Research, LLC
        • Contact:
          • Thomas A Eaton, PhD
          • Phone Number: 781-444-9605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

moderate to severe osteoarthritis of the knee .

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
OA
moderate to severe osteoarthritis of the knee

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Analgesic Solutions

Investigators

  • Principal Investigator: Nathaniel Katz, MD, Analgesic Research
  • Study Director: Thomas A Eaton, PhD, Analgesic Research

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2009

Primary Completion (ANTICIPATED)

May 1, 2009

Study Completion (ANTICIPATED)

June 1, 2009

Study Registration Dates

First Submitted

November 19, 2008

First Submitted That Met QC Criteria

November 19, 2008

First Posted (ESTIMATE)

November 20, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

November 20, 2008

Last Update Submitted That Met QC Criteria

November 19, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AR_08_MK_01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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