Osteoarthritis Bedside Testing Kit

Osteoarthritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00794651
• Other study ID #: AR_08_MK_01
• Status: Not yet recruiting
• Phase: N/A
• First received: November 19, 2008
• Last updated: November 19, 2008
• Start date: January 2009
• Est. completion date: June 2009

Study information

• Verified date: November 2008
• Source: Analgesic Solutions
• Contact: Thomas A Eaton, PhD
• Phone: 781-444-9605
• Email: teaton[@]analgesicresearch.com
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Observational

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: June 2009
• Est. primary completion date: May 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years to 85 Years

Eligibility

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 Design

Time Perspective: Prospective

Related Conditions & MeSH terms

• Osteoarthritis

Locations

Country	Name	City	State
United States	Analgesic Research, LLC	Needham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Analgesic Solutions

Country where clinical trial is conducted

United States,