Surgery – Diagnostic testing – Touch or pain response of skin
Utility Patent
1998-12-22
2001-01-02
O'Connor, Cary (Department: 3736)
Surgery
Diagnostic testing
Touch or pain response of skin
C600S587000
Utility Patent
active
06168569
ABSTRACT:
FIELD OF INVENTION
The invention relates to apparatus and a method generally useful in quantitatively relating levels of pain and activity experienced by a human subject. The invention relates more particularly, but not by way of limitation, to apparatus and a method for characterizing the level of activity of a medical or surgical patient based on measured parameters of activity and for relating the characterized activity to corresponding levels of pain reported by the patient, wherein pain and activity are related over a period of time sufficient to be useful in more quantitatively assessing the outcome of the patient in response to any therapeutic interventions such as surgery, physical therapy, the use of therapeutic devices such as braces or the administration of drugs.
BACKGROUND OF INVENTION
Many people who suffer from debilitating conditions undergo treatment to reduce pain and to restore physical function. In order to compare the effectiveness of the various treatments for a specific condition it is desirable to quantify patient outcomes. For example, patients suffering from arthritis may undergo a variety of treatments including physiotherapy, naturopathic treatment, drug treatment, intra-articular injection and surgery in order to restore function and reduce pain in affected joints. There is a need for apparatus and methodology useful in assessing the outcomes of patients in response to such treatments, thereby allowing better “value for money” decisions to be made in the allocation of health care resources. More specifically, there is a need for apparatus and methodology useful in characterizing the activity of patients and for relating the characterized activity to corresponding levels of pain over extended periods of time, so that any changes in the nature and levels of activity and related pain of patients in response to treatments can be more quantitatively evaluated. In this way, quantification of patient outcomes from various medical treatments may be useful in helping to identify the optimal treatment, or “best practice”, may also be useful in helping to identify patients who would not benefit from certain treatments, and may further be useful in evaluating staff performing such treatments.
In the field of orthopedics, patient outcomes can be measured in terms of the relief of pain and the restoration of function in a limb or joint. To assist in the assessment of the outcomes for patients in response to orthopedic treatments, there is a need for apparatus and methods to objectively measure and characterize the amount and type of activity undertaken by a patient and the relationship between this activity and associated levels of pain experienced by the patient so that any changes in response to treatments can be more objectively evaluated. Furthermore, it is desirable to determine this relationship over periods of time in which the full spectrum of activities representative of normal living by the patient may occur. There is also a need to include in such apparatus and methods means for indicating any short-term changes in the pain-activity relationship that may be related to events such as taking medications, as well as longer-term changes that may be the outcomes of various major treatments being assessed. No known apparatus or methods are known in the prior art which would meet these needs.
In the prior art, quantification of outcomes for orthopedic treatments has typically involved the use of questionnaires completed by the patient or the use of clinical instruments such as goniometers or arthrometers to measure physical parameters related to the structure of the joint. In this prior art there is no means to quantitatively measure the activity levels of an orthopedic patient over a period of time sufficient to include most of the activities of normal daily living of the patient and to relate the activity levels to corresponding levels of pain experienced by the patient.
Patient questionnaires such as the SF-36, the Western Ontario-McMaster University Osteoarthritis Index (WOMAC) and the Harris Hip Score (HHS) provide a means to generate scores indicative of disability that depend on a range of parameters including pain and activity as reported by the patient. However, no direct measurement of these parameters is undertaken and no provision is made to quantify the relationship between measured activity and the corresponding levels of pain intensity experienced by the patient. These questionnaires are typically provided as paper forms for the patient to complete. They are subject to a wide range of biases due to their subjective nature and require patients to summarize experiences over long periods of time, containing for example, questions such as “how much bodily pain have you had during the last 4 weeks” and “The following are activities you might do during a typical day—does your health now limit you in these activities?”
In the prior art there are many devices to measure and produce an indication of one component of patient activity. These include devices such as simple pedometers that provide a measure of the total number of steps taken by a subject as well as more sophisticated instruments that count steps or measure activity in terms of movement of an accelerometer type sensor applied to the patent. Typical of this prior art is that disclosed in U.S. Pat. No. 5,485,402, to Smith et al. Therein a gait activity monitor is disclosed comprising a sensor worn on the ankle, for measuring movement of the ankle relative to the environment. The monitor stores the signals from the sensor in a memory means and a processing means responsive to the movement signal provides a plurality of motion count units indicative of the number of movements that occur during consecutive measurement intervals. The device is intended to be worn over prolonged periods and includes apparatus to permit transmitting recorded data to a remote system computer for data processing. Typical of these devices, the Smith et al. patent fails to show or suggest apparatus capable of determining and recording information relating to the corresponding pain intensity experienced by the wearer during the measurement period, nor does it disclose apparatus relating to a processing means for determining the relationship between measured pain and activity and producing an indication of this relationship. Furthermore, devices found in the prior art generally only quantify one aspect of activity. Such devices do not provide a means to accurately characterize and differentiate between different types of activities normally undertaken by a patient such as reclining, standing and walking in a manner consistent with the methodology of common clinical questionnaires and as done by clinicians during patient exams and interviews.
Goniometers are also commonly used in the evaluation of orthopedic patients in order to measure and quantify the range of motion of a joint. Goniometers range from simple apparatus for measuring the angle between the two sides of a joint, to complex systems which quantify a wide range of parameters relating to range of motion of the joint and joint laxity. These devices are intended to take “snapshot” measurements and are not suitable for the dynamic measurement of joint function and activity during the activities of daily living. They are therefore of no value in assessing patient outcomes in terms of change in joint activity and associated pain.
Any report or rating of pain over a time period necessarily depends on the patient's memory of the pain experienced during the time period. Pain memory is well established as complex and problematic. Study of pain and its relation to activity involves estimates of pain over successive time periods, which are often quite lengthy and so is especially vulnerable to problems arising from reliance on memory for pain and activity data. Attempting to avoid such memory problems suggests that continuous tracking of current pain could be regarded as ideal. The most common method for measuring pain is a manually completed pain rating scale
Jameson Michael
Marko Alexei John
McEwen James Allen
Ipsolon LLP
O'Connor Cary
Wingood Pamela
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