Purpose of the Osteoarthritis Study

            The purpose of this study was to determine the effect of topically applied inorganic semiconductors on pain experienced by osteoarthritic patients.

Background and Significance of the Study

            Dambro (1996) defines osteoarthritis, the most common form of arthritis, as a chronic, progressive, degenerative joint disease. Osteoarthritis  pathophysiology is progressive degeneration of articular cartilage, reactive overgrowth of bone with lipping and spur formation at the margins, and changes in synovial membrane.

            Genetically governed susceptibility to joint breakdown; inflammatory response within caused by release of prostaglandins and inflammatory lysozymes; stretched nerve endings in the periosteum; muscle spasm and joint instability leading to stretching of the joint capsule; or microfractures in the subchondral bone or medullary hypertension caused by distortion of blood flow are considered possible causes of the painful symptoms of Osteoarthritis (Isselbacher et al., 1994; Rakel, 1995). Chronic pain of osteoarthritis is costly in dollars, personal suffering, decreased productivity, and quality of life (AF, 1996).

            Management of Osteoarthritis focuses on symptom abatement, which often includes treatment and regulation by healthcare professionals. Symptom management is often unsatisfactory for Osteoarthritis patients due to the subjectivity of the pain experience (Debock, Marwijk, Kaptein, & Mulder, 1994).  Currently accepted interventions include prescribed and over-the-counter medications, surgery, warm and cold applications, joint protection, exercise, and rest (Isselbacher et al., 1993).   

            Dissatisfaction with these interventions has led many Osteoarthritis patients to seek other therapies that have not been proven effective in repeated scientific studies. Eisenberg et al. (1993) reported that one in three respondents used alternative therapies to treat problems such as arthritis pain, making more visits to alternative practitioners than to U.S. primary care physicians.

            The Arthritis Foundation divides alternative treatments, into three categories entitled harmless, harmful, and unknown safeness. Alternative treatments that are considered harmless are copper bracelets, mineral springs, vibrators, and vinegar and honey. Remedies reported to be harmful are Dimethyl Sulfoxide (DMSO), large doses of vitamins, snake venom, and drugs with hidden ingredients such as steroids.

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Statement of the Problem

          Osteoarthritis patients in traditional healthcare settings usually have limited control of treatment prescribed for their pain. Nurse practitioners practice holistic healthcare that attends to the patient’s perception of pain and includes interventions that promote maximum self-care and an internal locus of control. As do other healthcare professionals, NPs rely on scientifically-based data to validate their treatment choices. An increasing need exists to study potential interventions for OA pain that are effective, safe, affordable, and allow for increased levels of patient control.                                                                     

Theoretical Framework

          The framework for this study was derived from Orem’s Theory of Self-care. Selfcare is defined as what individuals do to maintain life, health, and well being, or those patient behaviors that affect their health and shift decision-making to the patient. Self-care agency is the individual’s own ability to perform self-care. Orem (1985) categorizes the concept of self-perception as one of the basic capabilities of the self-care agent (individual). The individual’s purpose is based on sensory knowledge, awareness of the reality of the situation and on reflection on this awareness. A self-care deficit is an inability to perform self-care. This nursing theory assumes that self-care is learned through human interaction and communication (Orem, 1985).

          Three types of self-care requisites identified by Orem’s (1985) model are termed universal, developmental, and health-deviation. Universal self-care requisites are required to meet basic needs. Developmental self-care requisites are associated with specific stages of the life cycle. Health-deviation self-care requisites concern overcoming illness or functioning with chronic disease. Health-deviation self-care requisites describe osteoarthritis patients as they seek interventions that relieve their pain and therefore provide a better quality of life. 

          The three nursing action systems listed by Orem (1985) are wholly compensatory, partly compensatory, and supportive-educative. Wholly compensatory nursing concerns actions the nurse takes when compensating for a patient’s total inability to engage in self-care activities. Partly compensatory nursing actions are taken when the patient can perform some but not all self-care. Nurses provide supportive-educative action when the patient can learn to perform self-care, but needs assistance.

          Osteoarthritis patients usually seek care in a primary healthcare setting where NPs may use the supportive-educative nursing system. This system is used when teaching patients: when to treat their discomfort, what treatments to use, and how to most effectively utilize those treatments.

          Another tenet of this theory is that persons are capable and willing to perform selfcare (Orem, 1985).  Therefore, if OA patients are given information concerning safe, effective interventions to relieve the chronic, intermittent pain of OA, they will use these interventions when necessary, thereby increasing the patient’s ability to provide universal and developmental selfcare requisites.

Hypothesis

          The following hypothesis will be tested: There is a significant decrease in the reported Osteoarthritis pain of subjects receiving treatment of topically applied inorganic semiconductors as compared to subjects receiving placebo therapy. 

Definitions

          Conceptual and operational definitions for study variables are listed below.

          Alternative therapies (AT) are therapies that have not been investigated and/or approved by any government regulatory agency (Goldberg, 1995). Alternative is defined by Berman and Larson (1994) as, “systems of medicine and therapies that emphasize improving quality of life, disease prevention, and treatments for conditions for which conventional medicine has few, if any, answers”  (p. x). For the purposes of this study, ATs will be healthcare therapies that are not backed by repeated studies supporting their efficacy and/or safety.  

          Rare earth semiconductors are a scarce metallic element found in the earth’s crust. They are currently applied in athletic wraps for relief of pain and inflammation (D. McGhie, personal communication, May 23, 1997). For the purpose of this study, they will be a small hexagon shaped adhesive patch mixed with the adhesive.  The placebo will appear identical to the semiconductor patch, but will have no semiconductors added to the adhesive.

            Osteoarthritis, the most common form of joint disease, involves progressive loss of articular cartilage and reactive changes at joint margins and in subchondral bone (Dambro, 1994).  The most commonly reported symptoms are stiffness and chronic intermittent pain. For the purposes of this study, osteoarthritis patients will be subjects who report pain in interphalangeal joints and who have been diagnosed with osteoarthritis by a healthcare professional.

          Pain is “a feeling of distress, suffering, or agony, caused by stimulation of specialized nerve endings” (Miller & Keane, 1987, p. 411). Pain demands attention, disrupts behavior and thought, and may become overwhelming (Melzack, 1973).  For the purposes of this study, pain will be measured by the Short Form- McGill Pain Questionnaire.  

                                                            Assumptions

          The following assumptions were made for the purposes of this study:

1.                            Pain is an individual, subjective experience that is measurable and can be effectively evaluated by individuals who are experiencing pain.

2.                            Pain is a condition that threatens a person’s well being.

3.                            Subjects experiencing osteoarthritic pain desire alleviation of that pain.

4.                            Subjects desire pain management that is safe, cost-effective, and part of self-care.

          5.                Patients are capable and willing to perform self-care.

Limitations

Limitations of this study include:

1.                                Convenience sampling may create possible sample bias.

2.                                Osteoarthritic pain involves periods of remission and exacerbation and may vary in severity from individual to individual.

3.                                Patients may use other pain relief methods while using

the patch. 

Summary

            Osteoarthritis, the most prevalent non-inflammatory disease, produces pain and stiffness which often cause decreased work production and/or quality of life for its victims. Healthcare providers and their victims seek therapies which are safe, effective, and allow a measure of self-care for these symptoms. Studies have demonstrated Ge’s effectiveness in relieving acute musculoskeletal pain. This study involved the effect of semiconductors on chronic, intermittent Osteoarthritis pain. This chapter has presented the problem, purpose, hypothesis, assumptions, and limitations of this study. The study’s background and significance, theoretical framework, and terms were discussed.

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