LIPOWEAR

This application claims the benefit of our copeπding U.S. patent application with the serial number 11/277818, which was filed 03/29/06.

Field of The Invention The field of the invention is functional clothing, especially as it relates to undergarments with a padding that is configured to alleviate symptomatic discomfort associated with various conditions, and particularly lipodystrophy, lipoatrophy, and/or sarcopenia.

Background of The Invention Various conditions and diseases are associated with loss or maldistribution of body mass, and especially fat and muscle tissue. For example, long-term treatment of patients infected with the HIV virus is often accompanied by lipodystrophy, lipoatrophy, and/or sarcopenia. Similar problems are also encountered by patients undergoing chemotherapy for treatment of cancer, and/or long-term diabetes patients.

While pain due to lipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia can be treated with analgesics, drug therapy is often not desirable due to high costs and/or side effects of the drugs. Most significantly, loss of body mass, and especially loss of fatty tissue in the buttocks and legs typically lead to tenderness, and more typically severe pain in such patients which transforms routine daily activities {e.g., sitting on a chair, lacing shoes) into a challenge. Thus, the quality of life is significantly reduced and even prevents at least some of these patients from participation in ordinary daily life. Remarkably, there are numerous garments known in the art that increase sitting comfort of a person on bicycle seat or provide cushioning for sports activities, however, none of them has been shown to substantially alleviate personal discomfort for patients having lipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia.

For example, U.S. Pat. No. 4,984,304 describes an undergarment with a pad that shapes and uplifts the lower buttocks for cosmetic reasons. Clearly, such undergarment is not suitable for patients with lipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia and further fails to significantly cushion affected areas. In another example, as shown in U.S. Pat. No. 4,969,216, an undergarment has a large unitary cushion that is configured to cover i

the buttocks area. While at least some protection is provided to the pericoxxigeal area, the side and back of the legs, and the waist area remains unprotected.

Still further known undergarments with a pair of cushioned inserts are shown in U.S. Pat. No. 4,894,867, in which the pads are relatively small and designed for sports events. Similarly, even smaller and very thin buttock-protecting pads are provided in a comfort garment as shown in U.S. Pat. Nos. 5,103,505 and 5,749,101. Sport pants with larger padding are described in U.S. Pat. No. 5,649,328, in which inner, tight-fitting, and outer, loose-fitting shorts include inner and outer pads, respectively to provide cushioning to an inline skater in case of a fall. While such garments are generally suitable for their intended purpose, the padding is either too small to effectively protect back and legs of a person, or the sports garment is too bulky to be worn as undergarment. In yet other known garments, the cushioning pad has a unitary construction that extends across the crotch and is typically used in bicycling shorts as depicted in U.S. Pat. Nos. 4,961,233, 4,805,243, 5,365,610, and 5,271,101, and U.S. Pat. App. No. 2003/0131399. While such shorts typically significantly improve sitting comfort on a bicycle seat, the cushioning area is limited to the crotch area, which is of little or no help to a person suffering from lipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia.

Therefore, while numerous padded pants and undergarments are known in the art, all or almost all of them suffer from one or more disadvantages. Thus, there is still a need for improved undergarments that effectively and discreetly provide cushioning for the legs, buttocks, and belt area of a person wearing such garment.

Summary of the Invention

The present invention is directed to undergarments and methods therefor, and especially to form-fitted undergarments having a waist portion with a waist circumference and a leg portion with a leg circumference, wherein the ratio of the waist circumference to the leg circumference is higher than normal. Such undergarments include a padded area configured to provide preferably continuous protection extending from an upper area of the waist portion to a lower area of the leg portion such that the area of the buttocks and legs of a person contacting a seat (while sitting on a chair) are substantially completely covered by the padded area.

Most typically, the higher than normal ratio is characteristic of a person diagnosed with lipoatrophy, lipodystrophy, sarcopenia, HIV infection, a neoplastic disease, and/or chronic diabetes. For example, such contemplated ratios will be at least 1.9, and more typically at least 2.0 (as compared to a normal ratio of about 1.6 to 1.8, or lower). It is typically preferred that at least one of the waist portion and the leg portion comprises an elastic material, and/or the padded area extends to a substantially topmost and/or lowermost end of the waist portion and/or leg portion. Where desirable, the padded area is configured as an independent right and left area, wherein each area includes a removable pad. Furthermore, it is contemplated that the padded area and/or pad includes a plurality of vent openings and that it is further contoured to have a thicker than average thickness in the buttock area and optionally a thinner than average thickness in a peripheral area of the padded area.

In another aspect of the inventive subject matter, a method of providing symptomatic relief for a person suffering from HTV infection, chronic diabetes, neoplastic disease, lipoatrophy, lipodystrophy, and/or sarcopenia will comprise a step of providing the form- fitted undergarment according to inventive subject matter and a further optional step of informing the person that the undergarment reduces symptomatic discomfort associated with the conditions indicated above. Moreover, contemplated undergarments may also be of significant advantage where the patient is a geriatric patient as advanced age is often accompanied by loss of muscle tissue and/or fatty tissue in the buttocks and/or legs.

Alternatively, or additionally, a method of providing improved sitting comfort to a person is contemplated in which a form-fitted undergarment having a waist portion, a leg portion, and a padded area is provided, wherein the padded area is configured to provide protection extending from an upper area of the waist portion to a lower area of the leg portion such that the area of the buttocks and legs of a person contacting a seat (while sitting on a chair) are substantially completely (i.e. , at least 90%, more typically at least 95%) covered by the padded area. In another step, the person is informed that the undergarment will provide reduction in at least one of pain, numbness, local hemostasis, and deep vein thrombosis when the garment is worn during a prolonged period of sitting (e.g., over at least one, more typically at least two, and most typically at least three hours). Most preferably, the padded area in such methods has an average thickness of between 0.5 inch to 1 inch, and is contoured to have a thinner than average thickness in a peripheral area of the padded area. Furthermore,

it is generally preferred that the padded area is configured as an independent right and left area, wherein each area includes a removable pad.

Various objects, features, aspects and advantages of the present invention will become more apparent from the following detailed description of preferred embodiments of the invention.

Brief Description of the Drawing

Figure l is a photograph of a front view of an exemplary undergarment according to the inventive subject matter.

Figure 2 is a photograph of a rear view of the undergarment of Figure 1.

Figure 3 is a photograph of a padding insert of the undergarment of Figure 1.

Figure 4 is a photograph of the foam pad of the padding insert of Figure 3.

Figures 5A-5C depict top view (A), bottom view (B), and schematic/cross-sectional view (C) of the foam pad used in the clinical study reported herein.

Figure 6 is a graph illustrating the increase of length of sitting without discomfort in study participants using the undergarment according to the inventive subject matter.

Detailed Description

The inventor has discovered that quality of life of a person diagnosed with lipodystrophy, lipoatrophy, peripheral neuropathy, and/or sarcopenia can be significantly improved by providing a form-fitted undergarment that not only accommodates the altered anatomical features of such persons, but that also provides a relatively large padding to thereby reduce painful and potentially destructive pressure to the legs and buttocks during sitting.

It should be noted that patients diagnosed with the above conditions will typically exhibit a substantially reduced amount of muscle and/or fat tissue in the buttock area and/or the posterior thigh area, which exposes muscles, nerves, and blood vessels to significant compression and thus renders sitting even over a relatively short period not only painful but also potentially damaging to the compressed tissues. Unfortunately, loss of functional

vasculature and neuropathic pain are often common in such compressed tissues and further decrease sense of well-being for geriatric and/or patients diagnosed with the conditions listed above. Viewed from a different perspective, undergarments according to the inventive subject matter will not only distribute the weight of a sitting person from a few compression points to a relatively large area, but will also provide cushioning to the load-bearing surface of a body while the person is in a sitting position. Therefore, contemplated undergarments will significantly increase quality of life, allowing normal daily activities and social life, and thereby reducing depression and use of analgesics.

In one particularly preferred aspect of the inventive subject matter, the undergarment is configured as a form-fitting undergarment as depicted in Figure 1. Here undergarment 100 has a waist portion 110 with an elastic waistband 112 and optional drawstring 114. The leg portion 120 includes first and second legs 122A and 122B. Waist circumference is schematically indicated by arrow W, while leg circumference is schematically indicated by arrow L. In preferred aspects of the inventive subject matter, the ratio of the waist circumference W to leg circumference L in contemplated undergarments is higher (e.g., about 1.9-2.1) than a W to L ratio ordinarily encountered in form-fitted undergarments (e.g., about 1.6-1.8). While not limiting to the inventive subject matter, it is generally preferred that the waist is elasticized to allow a person to wear the undergarment above, at, or below the hip bones. Thus such garment can be worn with or without belt, or with loose or close fitted clothing.

Pads 130A and 130B are disposed in respective pouches (not shown), which are formed in the rear of the undergarment 100. Figure 2 depicts a rear view of the undergarment 100 of Figure 1. Here, the positioning and configuration of the pads 230A and 230B is more readily apparent. Most significantly, it should be noted that the pads in the exemplary embodiment are two separate pads that extend along the length X from the upper area of the waist portion to the lower area of the leg portion. In such exemplary undergarment, it should be noted that X is between about 75% to 95%, more typically about 80% to 95%, and most typically about 90% to 95% of the entire length of the garment. Similarly, the pads extend along the width Y from one side of the leg to the other side of the leg, wherein Y is typically at least 30% to 40%, and more typically at least 35% to 50% of the leg circumference L. The term "about" as used herein in conjunction with a numeral refers to a range of the numeral of +/- 5%, inclusive.

Figure 3 depicts the removable pad insert 330 of one side of the undergarment, while Figure 4 shows the contoured foam pad that is normally contained in a textile envelope to thereby form the pad insert of Figure 3. Here peripheral area 432 has a lower than average thickness (typically between ¹ A inch and less than ³ A inch), while the area proximal and overlapping the buttock area 442 has a higher than average thickness (typically between more than ³ A inch and 1 inch). A substantially horizontal seam may be included that assists in formation of a pad shape similar to a normal anatomy of buttocks. Vent openings 436 and lateral cuts 438 assist in heat and moisture transport across the pad and further allow for extra deformation. Of course, while the exemplary undergarment of Figure 1 is depicted for male users, it should be recognized that modifications known in the art can be made to accommodate female and/or pediatric users as well. It should be noted that contemplated pads and pad inserts may also have flex grooves and/or flex hinges that allow to the pad to conform to a persons anatomy while the person is moving. Among other advantages, such flexibility will reduce or even entirely eliminate the possibility for the undergarment to ride up or chaff during walking and sitting.

Thus, it should be recognized that a (preferably form-fitted) undergarment will typically include a waist portion with a waist circumference and a leg portion with a leg circumference, wherein the ratio of waist to leg circumference is higher than a normal ratio (see below). Such unusual ratio is not only considered beneficial in retaining the padded area in a desired place (prevents the pads from 'flopping around ¹ ), but is also though to provide support for the anatomical areas covered. Where the fit is relatively tight, such support may also provide drainage and/or vascular support. It is further generally preferred that a padded area is included that is configured to provide protection that extends from an upper area of the waist portion to a lower area of the leg portion. The protection is typically such that the area of the buttocks and legs of a person contacting, a seat (while sitting on a chair) are substantially completely covered by the padded area. The term "form-fitted" as used herein and with respect to a garment refers to a fit of a garment that generally follows the anatomy of a person. Therefore, and most typically, form-fitted undergarments will be in substantial complete {i.e., at least 80%, more typically at least 90%) contact with the persons body when worn by the person. While not limiting to the inventive subject matter, the waist portion and/or the leg portion will comprise an elastic material that assists in the form fit. As also used herein and with respect to a person, the term "ratio of waist to leg circumference is

higher than a normal ratio" means that the person's leg circumference relative to the person's waist circumference is abnormally greater than the same ratio of an average healthy person. In most cases, a higher than normal ratio is observed where the leg circumference is significantly reduced due to lipoatrophy and/or sarcopenia (which may be precipitated by a disease and/or advanced age [e.g., older than 65, and more typically older than 75 years]). Such higher than normal ratio may also (and/or further) be precipitated by exacerbated lipid accumulation around a person's waist (e.g., due to lipodystrophy) while having a normal or reduced leg circumference.

For example, a healthy person with a waist circumference (measured at about the navel) of about 34 to 40 inches will typically have a leg circumference (measured at about midpoint between knee joint and hip joint) of between about 20 and 24, resulting in a typical ratio of between about 1.60 to 1.80, and even lower. In contrast, in aperson with abnormal and reduced leg circumference and possible increased waist circumference, the ratio will typically be between about 1.9 to 2.2, and even higher. Most commonly, and viewed from a different perspective, ratios that are considered higher than normal will be those characteristic of a person diagnosed with lipoatrophy, lipodystrophy, sarcopenia (e.g., due to HIV infection, neoplastic disease, advanced age, and/or chronic diabetes). For example, higher than normal ratios will be at least 1.85, more typically at least 1.9, even more typically at least 2.0, and most typically at least 2.1.

It is further generally preferred that the padded area in contemplated undergarments will extend to the substantially topmost end of the waist portion and/or the substantially lowermost end of the leg portion. Thus, the length X of the padded area is preferably at least 70%, more preferably at least 80%, even more preferably at least 90%, and most preferably at least 92% of the entire length of the undergarment. It should be noted that such extensive length of the padded area will not only provide the lower portion of the legs with sufficient padding, but also protect the spinal area around the iliac crest from pressure of a belt worn with pants. Thus, the upper end of the padding in at least some of the embodiments is configured such that the padding extends to a position that is at, or even above the iliac crest of the hip bone when the undergarment is worn. In less preferred aspects, however, the upper end of the padded area may also extend to a position below the iliac crest (e.g., 1 cm below, less preferably 2 cm below, and even less preferably 2-6 cm).

With respect to the lower end of the padding, it is typically preferred that the lower end extends (preferably at least) to a position that corresponds to a portion of a leg in contact with a chair when a person sits on a chair. Therefore, viewed from another perspective, the lower end of the padding extends to a position that corresponds to the lower point of attachment of the adductor longus to the femoral bone, and even lower (e.g., at least 1 cm, more typically at least 2 cm, and most typically at least 2-5 cm). Viewed from yet another perspective, the padding extends to a position that is about 30 cm above the knee, more typically between 30 cm and 20 cm above the knee, and most typically between 20 cm and 10 cm above the knee (when the undergarment is worn on a person). With respect to the width Y of the padded area in the leg portion, it is generally preferred that the padded area extends to at least 30% of the leg circumference, and more typically at least 40% of the leg circumference. Viewed from a different perspective, the width (and length) of the padding is preferably selected such that the padding will cover the entire area of a leg and buttocks that would otherwise make contact with a seat surface when the person wearing the undergarment is sitting on a chair. Consequently, it is contemplated that the ratio of padded area to the entire garment area (inside) is between about 20% to 80%, more typically between about 30% and 70%, and most typically between about 35% and 65%.

Most typically, the padded area comprises an independent right area and left area, each containing at least one padding element, which is most preferably a removable pad. However, in less preferred aspects, the padded area may also comprise a single padding element covering both sides of the body. The padded area and/or padding elements preferably comprise a plurality of vent openings through which moisture and heat can dissipate. It is still further preferred that the padded area and/or padding element is further contoured to enhance it's functional and/or esthetic character. For example, it is typically preferred that the padded area and/or padding elements have a thicker than average thickness in the buttock area while having a thinner than average thickness in the periphery of the padded area. The padding will preferably comprises a molded, or shaped and precut foam pad, which will typically be made of medical quality foam, high-grade furniture padding, memory foam, open cell foam, or other elastomeric material that will retain its shape over a prolonged period of use. Alternatively, it is also contemplated that the padded area may comprise a plurality of padded elements that can preferably be individually inserted, exchanged, and/or removed to either personalize the undergarment to a particular body shape, and/or to achieve a desirable

body contour while wearing the undergarment. It should be noted that it is especially preferred that the undergarment according to the inventive subject matter is worn underneath a regular pair of pants, and that the undergarment will therefore serve at least two distinct functions. First and foremost, contemplated undergarments will reduce if not even eliminate subjective discomfort associated with sitting. Second, and especially where the wearer suffers from lipoatrophy and/or sarcopenia, contemplated undergarments will provide a more desirable body profile when worn with relatively tight fitting pants.

With respect to the padding material, it is generally contemplated that all elastic materials are suitable, however, especially preferred materials have an elasticity such that the padding is compressed to less than about 60% (or less than 30-50%, or less than 50-60%, but also less than 60-70%, and even higher) of full compression when a person's weight compresses the padding in use in garments contemplated herein. Therefore, suitable materials include high-grade synthetic foam commonly used in medical uses and/or furniture trade, but also other materials, including memory foam, optionally foamed polymers (e.g., polyurethane, polyethylene, etc.), and all reasonable combinations thereof. Furthermore, it should be recognized that the padding may have a thickness and/or density that is not even, especially where the material is molded. For example, areas of higher weight load may have a greater thickness as compared to areas where less weight load is commonly expected (e.g., side of the legs). Additionally, or alternatively, the padding maybe configured such that a user can adjust the thickness (e.g., by adding or removing material).

In further aspects of the inventive subject matter, it is contemplated that the padding may be permanently coupled to the garment (e.g., directly sewn in, or enclosed in a pouch), or that the padding may be temporarily retained at a predetermined location (slipped into an envelope, attached via hook-and-loop fasteners, buttons, snaps, etc.). Still further, in less preferred aspects, it is contemplated that the entire garment may be fabricated from a padding, wherein the areas to be protected correspond to areas contemplated above and are of greater thickness, while the non-protected areas may be fabricated from a relatively thin padding. The padding may thereby be added to the garment in a manner such that the padding or portion thereof forms a portion of a design element, or in a manner such that the padding is substantially invisible from the outside of the garment when the garment is worn on a person.

Regardless of the particular nature and configuration of the padding, it is contemplated that the non-padding portion of the undergarment may be formed from all materials known in the art, and particularly suitable materials include cotton, synthetic and natural fibers, wool, and all reasonable combinations thereof. For example, especially suitable materials include wicking fabrics, and particularly lycra, polyester, spandex, and all reasonable combinations thereof. Moreover, preferred materials also include fabric with added or built-in antimicrobial properties. Still further, it is contemplated that padding to reduce painful conditions (e.g., due to lipodystrophy, lipoatrophy, and/or sarcopenia) may be included in clothing articles other than undergarments. Therefore, contemplated alternative garments include shorts, pants, shirts, shoes, socks, etc., wherein the padding is provided in areas to reduce pressure to one or more anatomic structures. In still further contemplated aspects, the undergarment may also be made from a material with sufficient resiliency to allow formation of a compression garment that supports and compresses a wearers body.

Especially contemplated uses include those in which symptomatic relief from pain and other discomfort associated with HTV infection, chronic diabetes, neoplastic disease, lipoatrophy, lipodystrophy, sarcopenia, and/or advanced age is provided by wearing the undergarment according to the inventive subject matter. Additionally, the inventor observed that contemplated undergarments also provide relief from generalized or non-specific hip and pelvic pain, which may be due to injury, osteoarthritis, and/or osteonecrosis (or other unknown etiology). Such methods may further include various steps of providing information that the undergarment will provide symptomatic relief, improve appearance, quality of life, and/or reduce pain in a person wearing the undergarment. Information may be provided in numerous manners, including pictorial information, written description, and/or auditory information. Consequently, advantages and properties of contemplated undergarments may be advertised on a sales brochure, on the packaging in which the undergarment is contained, in websites, etc. Therefore, target markets for such undergarments will include geriatric patients, HTV patients, post-surgical patients with hip and/or thigh bone surgery.

Further contemplated uses include those for healthy persons that are subject to relatively long periods of sitting. For example, a method of providing improved sitting comfort to a person may include a step in which a form-fitted undergarment having a waist portion, a leg portion, and a padded area is provided, wherein the padded area is configured to

provide protection extending from an upper area of the waist portion to a lower area of the leg portion such that buttocks and legs of a person contacting a seat while sitting on a chair are substantially completely covered by the padded area (average thickness of between 0.5 inch to 1 inch). In another step, the person is informed that the undergarment provides reduction in at least one of pain, numbness, local hemostasis, and deep vein thrombosis when the garment is worn during a period of sitting over at least three hours. While such persons are typically of advanced age, younger persons are also expressly contemplated herein. With respect to the undergarment, materials, and dimensions, similar, or even same considerations as described above apply.

Examples

To determine the impact of the form-fitted undergarments according to the inventive subject matter in persons with lipoatrophy of the legs and buttocks and sitting pain on sitting comfort, quality of life and the ability to participate in sitting activities associated with various life activities, the following study was performed.

Product Tested

The form-fitted undergarment used in this study (LipoWear Shorts) had the following features: Foam pads were anatomically designed for sitting pain relief and had the general shape as depicted in Figures 5A-5C. As can be seen from Figure 5A, the top sides of the padding inserts were profiled top-to-bottom and side-to-side, and included two non- perforating cutouts to assist flexing of the padding in the central area of the buttocks. The bottom sides of the padding included a plurality of vent openings perforating the thickness of the padding and having a geometry in which the opening proximal to the skin has a larger diameter that the opening distal to the skin as shown in Figure 5B. Moreover, a non- perforating cutout was provided to assist flexing of the padding to conform to the posterior iliac crest. The vent openings were provided to allow heat loss, and the padding was further covered by a fabric layer on the skin side that allowed wicking of perspiration. An adjustable waist band was provided and the undergarment was form-fitted to be contoured to the body. As can be seen from Figure 5C, the padding was shaped such that at least 70% of the top and bottom sides were profiled in a curved profile to both conform to the anatomy of the wearer but also to add material in a manner that would result in a more natural look of the wearer.

Foam pads were inserted into respective pockets of an elastic undergarment that was cut and sewn to be form fitted for a waist to leg circumference ratio of at least 1.9.

Study Design

Subjects meeting the protocol criteria were enrolled in a two month, open label study at three HIV private practices in southern California.

Subject Inclusion Criteria: Male, small waist size at 28-30 inches or medium waist size at 32-34 inches; age IS or older; HIV-infected; presence of lipoatrophy in the legs and buttocks; presence of pain and discomfort when sitting; English speaking and capable of completing questionnaires & diaries; able to complete 2 month study.

Subject Exclusion Criteria: Substance abuser; mental instability likely to interfere with study participation; scheduled medical procedure requiring hospitalization during 2 month study; allergic to synthetic fabrics or foam.

Main Outcome Measures

Sitting pain relief and Quality of Life improvement as measured by Multidimensional Quality of Life Questionnaire for Persons with HIV/ ADDS (MQOL-HIV) developed by the New England Research Institutes, Inc. Four of the ten domains in the MQOL-HIV where pain relief would potentially provide a benefit were selected for analysis: Physical Function, Social Function, Cognitive Function and Mental Health. Each Domain had four questions. Each question was scored on a 7 point Likkert scale. The scores for certain questions are reversed so that an increase in score represents an increased quality of life. In addition, sleep restlessness was evaluated on a 5 point scale from not restless to extremely restless. Outcome measures were determined at baseline, 1 and 2 months. Statistical analysis compared baseline and month 2 endpoints.

Statistical Methodology

Sitting comfort time was evaluated using a one-sided t-test. Sleep restlessness was evaluated using a one-sided, matched pairs t-test. Quality of Life mean scores were evaluated using two methodologies, the matched pairs t-test and the Wilcoxon sign-rank test, a nonparametric test.

Results

31 subjects were enrolled in the study and 24 completed the two month evaluation. Five subjects dropped out due to medical complications that prevented them from making office visits. Two subjects dropped out due to inappropriate size issues.

The mean age of the subjects completing the study was 53 and the mean length of

HIV antiviral treatment was 10 years. The degree of lipoatrophy in the buttocks and legs was determined by participating physicians. Three subjects (12.5%) exhibited mild lipoatrophy, 10 subjects (41.67%) were judged as moderate, and 11 subjects (45.83%) were judged as severe. Baseline sitting comfort decreased as the degree of lipoatrophy severity increased as shown in Table 1:

Degree of Lipoatrophy Number of Subjects Baseline Sitting Comfort (minutes)

Mild 3 23

Moderate 10 13

Severe 11 7

Mean of all categories 11.58

Table 1 Sitting Comfort & Degree of Lipoatrophy

Sitting Comfort

The study demonstrated a statistically significant increase in sitting comfort. At baseline, subjects were able to sit comfortably for a mean of 11.58 minutes. At the two month conclusion of the study, mean comfortable sitting time had increased to 189 minutes (p=.0001). Figure 6 illustrates the significant change in mean length of sitting comfort time.

Sleep Restlessness

Sleep restlessness improved significantly (p=.OOO8). 16 of the 24 patients improved one or more levels, 6 stayed the same and 2 reported increased restlessness as shown in Table 2.

Baseline Mean Month 2 Mean Difference Matched Pairs T-Test Wilcoxon Sign-Rank Prob < t Prob <Z

2.66676 1.75000 -.09167 .0008 JOOl

Table 2 Change in Sleep Restlessness

Quality of Life

All four Domains of the Quality of Life evaluated improved over the 2 month study. The study demonstrated a statistically significant increase in the mean scores of two Domains, Physical Function and Social Function (p=.O2). The mean scores of the Mental Health, and Cognitive Function Domains improved at the p=.l level as can be taken from Table 3.

Variable Baseline Mean Month 2 Difference Matched Pairs Wilcoxon Mean T-test Prob > t Sign-Rank Prob > Z

Mental Health Domain Total 18.08 19.39 1.31 0.105 0.072

Physical Function Domain Total 17.88 20.13 2.26 0.020 0.032

Social Function Domain Total 19.17 20.83 1.65 0.023 0.019

Cognitive Function Domain 20.38 21.57 1.19 0.110 0.290 Total

Table 3 Quality of Life Composite Domain Analysis

When the 4 questions in each Domain were analyzed individually, the sample means of 15 out of 16 questions improved, and one remained unchanged. In the Mental Health Domain, depression improved significantly (p=.O45). In the Physical Function Domain, doing more around the house and doing more outside the house improved significantly (p=.007 and .014 respectively). In the Social Function Domain, feeling isolated, lacking energy to socialize and spending quality time with friends improved significantly (p=.O43, .035, and .004 respectively). In the Cognitive Function Domain, trouble remembering things and short attention span improved at the p=.O58 and .082, respectively, as can be seen from Table 4.

Baseline Mean Month 2 Difference Matched Pairs Wilcoxon Mean T-test Prob > t Sign-Rank Prob > Z

Mental Health

Ql "You felt depressed" 4.87 5.43 0.57 0.045 0.019

Q2 "You felt anxious" 5.09 5.43 0.35 0.194 0.205

Q3 "You felt needed" 3.91 3.96 0.04 0.439 0.443

Q4 "You worried about things" 4.13 4.57 0.43 0.102 0.090

Physical Function

Q9 "do things around house" 4.52 5.43 0.91 0.007 0.008

QlO "get from place to place" 5.35 6.00 0.65 0.014 0.016

Q Il "climb stairs" 5.17 5.22 0.04 0.454 0.608

Q 12 "perform strenuous 3.13 3.48 0.35 0.143 0.176 sports"

Social Function

Q 13 "You felt isolated" 4.95 5.45 0.50 0.043 0.060

Q 14 "withdrawn from 5.18 5.18 0.00 0.500 0.531 socializing" Q 15 "lacked energy to 4.73 5.27 0.55 0.035 0.047 socialize: Q 16 "spent quality time with 4.23 4.91 0.68 0.004 0.006 friends"

Cognitive Function

Q 21 "trouble remembering 4.83 5.26 0.43 0.058 0.065 things" Q 22 "forgetting what you 4.96 5.17 0.22 0.244 0.250 started" Q 23 "mind wanders" 5.13 5.35 0.22 0.229 0.258

Q 24 "short attention span" 5.30 5.78 0.48 0.082 0.123

Table 4 Domain Question Analysis

As a result of sitting pain relief, subjects reported being able to participate longer and concentrate better in a wide variety of activities including: choir, church, computer time, concerts, doing bills, driving, meditation, meetings, movies, plane travel, reading, restaurants, school, seminars, shopping, socializing, theater, walking, watching TV, work, writing letters, yard work and yoga. This expansion in activities contributed to the improved Quality of Life Rating scales in the multiple domains noted above.

In general, subjects also reported decreased use of pain medications, rated the quality of their life as improved significantly, rated their appearance as improved significantly and rated the product as very useful. Multiple comments were received from the subjects as to the importance of the padded shorts restoring a normal body contour which resulted in an improved appearance. 100% would recommend the product to others.

Discussion

The emergence of lipoatrophy and subsequently sitting pain as an important clinical component of long term HIV treated subjects has lead to the recognition of the impact of sitting pain on the lives of these subjects. As a result of this often debilitating sitting pain, withdrawal from activities increases which results in a decreased quality of life. This study

shows that a discreet, anatomically designed, padded undergarment allows subjects extended sitting comfort and improved appearance which in turn allows them to return to activities reduced or abandoned and increases the quality of life. LipoWear Shorts significantly improved sitting pain comfort and appearance and significantly increased the quality of life in subjects with lipoatrophy and sitting pain

Thus, specific embodiments and applications of functional undergarments have been disclosed. It should be apparent, however, to those skilled in the art that many more modifications besides those already described are possible without departing from the inventive concepts herein. The inventive subject matter, therefore, is not to be restricted except in the spirit of the appended claims. Moreover, in interpreting both the specification and the claims, all terms should be interpreted in the broadest possible manner consistent with the context. In particular, the terms "comprises" and "comprising" should be interpreted as referring to elements, components, or steps in a non-exclusive manner, indicating that the referenced elements, components, or steps may be present, or utilized, or combined with other elements, components, or steps that are not expressly referenced. Furthermore, where a definition or use of a term in a reference, which is incorporated by reference herein is inconsistent or contrary to the definition of that term provided herein, the definition of that term provided herein applies and the definition of that term in the reference does not apply.