Technical Description of Pain Survey Clinical Study (For Medical Professionals)

This clinical study will evaluate pain location, quality of pain and functional disability in subjects with chronic pain. Subjects will be identified in this portion of the study using the Internet, but other components of the study will use a variety of enrollment methods, including newspaper advertising, medical clinics, doctors’ offices, and public recruitment drives. Informed consent will be obtained in all subjects. No therapies will be disallowed and no study drug will be administered. Pain shapes drawn by study subjects will be analyzed by computer to provide automated identification of body location and other statistical measures. These data will be analyzed together with body-location-specific data on the nature of the symptoms and the functional disability associated with pain. Subjects will be allocated to data-driven pain patterns of potential diagnostic value.

The highest ethical standards will be followed in this study. This study will be conducted in compliance with 1) Good Clinical Practices (GCPs), 2) the most recent version of the Declaration of Helsinki, 3) the approval of an Institutional Review Board (IRB) in accordance with the US Code of Federal Regulations, and 4) a Confidentiality Certificate (CC) from the US government. Confidentiality of personal data on study subjects will be stringently protected. All personal study subject data collected and processed for the purposes of this study will be managed by the investigator and the investigator's staff with adequate precautions to ensure the confidentiality of those data, and in accordance with applicable US federal and/or local laws and regulations on personal data protection. Access to individual data on study subjects will be made available to the IRB or other agents only as permitted by the confidentiality commitments to study subjects and by applicable law and regulations. In any presentation of the results of this study at meetings or in publications, the subjects’ identities will remain confidential.

Subjects must be adults with chronic pain (defined in this study as: "constant or recurring pain lasting more than 30 days and causing significant discomfort or limitation of activity"). There is no generally accepted definition of chronic pain -- different definitions use durations of anything from 30 days to 6 months. The analysis of this study will examine the results separately for different durations of chronic pain.

Key features of the study include:

• Subjects will make pain drawings that will be analyzed by subsequent computer analysis.

• Data on pain symptoms and functional disability will also be collected.

• Preliminary work by TMT has confirmed the generally accepted view that the cause of chronic pain is substantially related to the part of the body where the pain is felt, to the nature of the pain symptoms experienced, and to the associated functional disability.  However, no systematic study has been performed where pain location has been precisely characterized and then correlated with pain symptoms and functional disability. The availability of TMT's novel computer analysis system now makes such a systematic study possible.

• Subjects will be allocated to data-driven pain patterns associated with pain location, pain quality, functional disability, and combinations of these three variables.

• The relationship of pain duration, age, sex and geographic location to the above pain patterns will be evaluated.

• Data from each enrollment method (advertisements in local newspapers, medical clinics, doctors’ offices, public enrollment drives, and use of an Internet enrollment site) will be compared to determine if clinical results obtained are independent of the enrollment method, and also to evaluate the advantages and disadvantages of each enrollment method. The numbers of “hits” on the study Internet site will be tracked and correlated with levels of activity for each of the enrollment methods. The user interface may be simplified by a Java applet to be introduced after the study is underway; the impact of the anticipated improvement in ease-of-use would then be evaluated by tracking Web site "hits" and numbers of evaluable questionnaires submitted.

• Subject demographics will be reviewed for comparability with the demographic patterns of the populations from which the subjects have been recruited. Analysis will, as far as possible, take into account the two principal sources of survey error – questions improperly phrased to elicit the information required, and lack of comparability of survey respondents to the target population. In addition, measures will be taken to identify intentionally spurious responses. In general, consistency of results across groups enrolled using different enrollment methods may be considered to support the general applicability of the results.

• An important consideration for the Internet/email component in this study is that Internet and email users in general (and survey responders in particular) are not representative of the entire population in important ways – they tend to be wealthier, better educated, younger and with a higher male/female ratio. Thus, one might anticipate, for example, more sports injuries and fewer degenerative joint diseases than in the entire chronic pain population. Use of demographic data such as age and sex in the data analysis may allow some adjustment for these factors.

• It is worth noting that the problem of extrapolating results from the sampled population to a more general population is not unique to Internet clinical studies -- it is, rather, a near-universal issue in clinical research.  Those agreeing to participate in a clinical study are often not representative of the general population fulfilling the inclusion and exclusion criteria for a study -- whether subjects are enrolled from hospitals, medical clinics, private practices, newspaper advertisements or by use of other recruitment methods. In addition, inclusion and exclusion criteria for a clinical study often result in restriction of enrollment to a small minority of those patients who have the disease being studied.

• As in science in general, results need to be replicated in different studies and different settings before the conclusions reached can be generally applied. Any conclusions on pain location and pain symptoms derived from an Internet/email survey will require confirmation in a different population before results can be extrapolated to that population. In addition, the present study (which collects only subject self-reported information) will not include physician-based diagnoses. Accordingly, it is planned to add a diagnostic component in subsequent studies evaluating the pain patterns identified in the present study.

• These subsequent studies will be of patients seen in pain specialist clinics where a definitive diagnosis will normally be available. One pain specialist study would enroll new chronic pain patients, pain drawings would be completed by both patient and physician, and patients would be allocated to pre-defined diagnostic categories. Another pain specialist study would utilize the capability of the TMT computer analysis system to "map" common points between two human body image designs, allowing transfer of pain shapes between the designs. This capability would allow legacy pain drawings (from many different sources and from many pain specialist groups) to be converted to drawings on a single body image design which could then be analyzed using the TMT computer system and correlated with diagnostic findings.

Click Computer Analysis for more detailed information on the computer analysis of the pain drawings.

Click References for a list of publications related to pain drawings, Internet and other survey methods, and computer analysis of biological images.

Physicians wishing to participate in the present clinical study, or who are interested in participating in the pain specialist studies, should contact Colin R. Taylor, MD:  crtaylor@masterdocs.com or Colin R. Taylor, M.D., TMT Inc., 196 E 75th Street (Suite 18A), New York, NY 10021, USA.  We also have openings for a limited number of MasterDocs Fellows.