Project
Arthritis is generally characterized by joint inflammation but cannot be defined as any singular disease. It can be resultant of various injuries and diseases and have varying symptoms depending on the afflicted individual, but it always refers to net inflammation of a joint. Over one hundred different types of arthritis have been documented. Arthritis results in joint pain, stiffness, and decreased range of motion [1]. The most common type of arthritis is osteoarthritis, followed by rheumatoid arthritis. Osteoarthritis is the product of degeneration, in which the cartilage between the bones wears away, causing the joint to experience direct bone-bone contact. The direct contact between bones both causes pain and further degeneration. Most commonly, osteoarthritis results from either repetitive movements, injury, or surgery. Rheumatoid arthritis is a product of the individual’s immune system. Joint inflammation results from an auto-immune attack on the individual’s own joints. This perpetual inflammation not only decreases mobility and increases pain, but it can also have a degenerative effect on the bones and cartilage of the area [2].
The ideal outcome for an arthritic patient improves exponentially with early detection and diagnosis, which allows for the process to be slowed and further degeneration decreased. However, there exists a multitude of pharmacological, surgical, physical therapy, and temperature interventions for the treatment or management of arthritis. Existing pharmacological interventions are systemic treatments. Therefore, the potential products, such as analgesics and corticosteroids, are nonspecific. Surgery is extremely invasive, thus increasing the risk, while maintaining a high likelihood for long-term failure. Temperature therapy is not only proven to be effective; it is also both location-specific and noninvasive. However, the temperature therapy market is saturated only by either single-use chemical packs or uncontrolled heating pads, none of which provides an effective feedback system for control of a therapeutic program [3].
The major stakeholders this project affects are the health care providers, insurance groups, and patients. The project, however, does not present a significant source of contention to any of these groups. Although insurance coverage, or the lack thereof, will notably affect the socioeconomic reach of the device, the relatively low cost of the device will help to minimize the consequences. Although the proposed device is designed for at-home use, it does not remove the need for healthcare professionals. Instead it simply augments the treatment possibilities.
[1] Barbour KE, Helmick CG, Boring M, Brady TJ. Vital signs: Prevalence of doctor-diagnosed arthritis-attributable activity limitation – United States, 2013-2015. Morb Mortal Wkly Rep, 66(9):246-53, 2017. [2] Centers for Disease Control and Prevention. Arthritis. Accessed November 11, 2019. [3] Hayes KW. Heat and cold in the management of rheumatoid arthritis. Arthritis Care and Research, 6(3):156-166, 1993.
Contrast Bath Therapy
Cold
Cold treatment has been shown to decrease pain and inflammation in patients. In addition to the known decrease in nerve conduction velocity and blockade of impulses in nerves, recent studies have shown an endorphin release in response to cold treatment. This endorphin increase is said to be responsible for an additional pain minimizing effect [1]. The accompanying vasoconstriction effectively decreases swelling and limits the inflammatory response. In twenty published contrast bath therapy studies, the minimum water temperature ranged from 7.2 to 22 °C [2]. 16 °C falls within the range of cold water temperatures for 11 of 20 referenced studies, with the remaining nine exceeding the published threshold for pain. Thus, the series of cold treatments provided by this device have been specified to occur at 16 °C.
Hot
Heat has been shown to decrease pain and increase periarticular tissue extensibility by increasing blood flow to the region, thus washing out metabolites. Several hot water immersion studies using patients with rheumatoid arthritis have shown an overall increase in joint mobility and decrease in perceived stiffness following the treatment [1]. The hot water temperature in previous contrast bath therapy studies ranges from 27 to 45 °C. The therapeutic temperature range for heat therapy has been defined as 40 to 45 °C, with the intraarticular temperature of joints in patients with rheumatoid arthritis raised as much as 3.3 °C over that of the joints of non-diseased patients [2]. A study employing synovial cell cultures from non-diseased and rheumatoid arthritis patients exposed each cell culture to varying temperatures. Hyaluronic acid, lactic acid, and glucose production, all indicators of synovial metabolic activity and functions of blood perfusion and inflammation levels, increased throughout the temperature range of 32 to 38 °C. However, all three levels decreased significantly once reaching 41 °C [1]. Although this data was gathered in vitro and, thus, cannot be assumed as the behavior of an in vivo model, it provides a physiological snapshot of effective temperature ranges for therapeutic benefit. In evaluating the temperature ranges for the 20 contrast therapy studies considered, 42 °C fell within the hot water temperature range of 16 studies. The 4 exceptions were those in which extreme temperatures exceeding the pain threshold were used. Thus, the specification for cold treatment temperature of this design was chosen as 42 °C.
[1] Hayes KW. Heat and cold in the management of rheumatoid arthritis. Arthritis Care and Research, 6(3):156-166, 1993. [2] Stanton DEB, Lazaro R, MacDermid JC. A systematic review of the effectiveness of contrast baths. Journal of Hand Therapy, 22(1):57-70, 2009.