Evaluation of Pain Location, Pain Quality and Pain Patterns in Subjects With Chronic Pain

• ClinicalTrials.gov Identifier: NCT00284245
• Recruitment Status: Unknown
• First Posted: January 31, 2006
• Last Update Posted: June 28, 2011
• Sponsor: Taylor MicroTechnology
• Information provided by: Taylor MicroTechnology

Tracking Information

• First Submitted Date: January 30, 2006
• First Posted Date: January 31, 2006
• Last Update Posted Date: June 28, 2011
• Study Start Date: June 2004
• Primary Completion Date: Not Provided
• Current Primary Outcome Measures: Not Provided
• Original Primary Outcome Measures: Not Provided
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Evaluation of Pain Location, Pain Quality and Pain Patterns in Subjects With Chronic Pain
• Official Title: Internet-based Study of 10,000 Subjects With Chronic Pain, Including Subject-drawn Pain Diagrams, and Computer-generated Composite Images of Pain Patterns
• Brief Summary: In earlier work, the Sponsor developed a computer image processing system for analysis of pain diagrams from patients with chronic pain. This system was then tested in a study in over 500 chronic pain patients seen by both primary care practitioners and pain specialists. The hypothesis was that pain location would correlate with the pain type and the underlying cause of the pain. In the study, the computer analysis demonstrated clear correlations between pain diagram data and diagnosis/pain type. The present study extends these observations in a web-based setting, with a focus on the value of computer analysis of pain diagrams as diagnostic predictors.
• Detailed Description: Earlier work performed by the Sponsor (TMT) included development of a MatLab/ImageJ computer image processing system for generation of composite images from pain diagrams drawn by patients with pain, and for calculation of related quantitative variables. The system was tested in a pharmaceutical company-sponsored US study in over 500 chronic pain patients seen by primary care practitioners, and then seen by pain specialists. The hypothesis was that pain location would correlate with the pain type and the underlying cause of the pain. TMT's analysis established correlations between the pain diagram information and the underlying diagnosis and pain type (e.g., nociceptive or neuropathic) reported by the pain specialists. The present study extends these observations in a web-based setting, with particular emphasis on automated computer-generated visual pain patterns as diagnostic predictors.
• Study Type: Observational
• Study Design: Observational Model: Cohort; Time Perspective: Prospective
• Target Follow-Up Duration: Not Provided
• Biospecimen: Not Provided
• Sampling Method: Non-Probability Sample
• Study Population: Volunteers recruited in Internet study.

Condition

• PAIN
• CHRONIC DISEASE

• Intervention: Not Provided
• Study Groups/Cohorts: Not Provided
• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Unknown status
• Estimated Enrollment (submitted: January 30, 2006): 1000
• Original Enrollment: Same as current
• Study Completion Date: Not Provided
• Primary Completion Date: Not Provided

Eligibility Criteria

Inclusion Criteria:

• Male and female subjects at least 18 years of age and of legal age of consent for the state in which they live.
• Able to respond to a questionnaire written in English.
• Report chronic pain (constant or recurring pain lasting more than 30 days and causing significant discomfort or limitation of activity).
• Provide informed consent to participate in the study.

Exclusion Criteria:

• Currently participating in another clinical trial.
• Institutionalized person such as a prisoner or nursing home resident.
• Questionnaire response suggests a medical or psychological condition that, in the opinion of the investigator, would compromise participation in the study, or suggests any other condition which, in the investigator's judgment, might increase the risk to the subject or decrease the chance of obtaining valid data.
• Pain has resulted in a workman's compensation case.
• Pain has resulted in litigation.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT00284245
• Other Study ID Numbers: TMT-B-011; 04076-01
• Has Data Monitoring Committee: Not Provided
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Colin R Taylor, Taylor MicroTechnology, Inc.
• Study Sponsor: Taylor MicroTechnology
• Collaborators: Not Provided

Investigators

• Principal Investigator: Colin R Taylor, MD; Taylor MicroTechnology, Inc.

• PRS Account: Taylor MicroTechnology
• Verification Date: September 2006