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The right mattress can significantly contribute to decreased back and neck pain, and increase the ability to feel rested after a good night’s sleep. Using the wrong mattress can cause general aches and pains, aggravate any pre-existing pain, and lead to sleeplessness.

Many patients ask us, “What is the best mattress to buy?” Unfortunately, there has not been extensive medica

According to USFDA, a combination product is one composed of any combination of a drug and device; biological product and device; drug and biological product

l research or controlled clinical trials on the topic of mattresses and back pain. (Claims that a mattress is “orthopedic” or “medically-approved” should therefore be viewed skeptically.) Mattresses are largely a matter of personal preference. This is due to several factors: 1. There are many different types and causes of back problems. What works for one person might no

; or drug, device, and biological product and fixed dose combination would include two or more combinations of drug.

Examples of combination products may in

t be the best option for another. 2. Our bodies are all different. Different weights, heights, and builds may help dictate what one should look for in a mattress or pillow. 3. The causes of back pain are quite complex, and it’s difficult to isolate whether or not a mattress or pillow has played a significant role in causing pain. 4. In addition to mattresses and pillows, t

lude drug-coated devices, drugs packaged with delivery devices in medical kits, and drugs and devices packaged separately but intended to be used together.

ere are other factors that affect sleep comfort. Medication side effects, irregular sleep patterns, use of caffeine/alcohol/tobacco, sleep apnea, obesity, and anxiety/stress are all common causes of disrupted sleep.

General Rules of Thumb When Choosing a Mattress

Most people prefer a firmer mattress that provides more support. A good mattress should provide support while al

here is enormous increase in the number of combination products entering the market in the recent years. Combination products have proven advantages but fixe

lowing for the natural curves of the spine. A mattress is too soft if it sags, or if a second person in the bed causes the other to dip toward the center. Studies have found that a medium-firm mattress provides the best back support and alleviates the most back pain. A mattress that is too hard, though, causes aches and pains at pressure points, such as the shoulders and hip

d dose combinations are still in the process of convincing regulatory authority on their advantages over the single ingredient formulations.

Combination pro

. A mattress is too firm if there are gaps between any part of your body and the mattress. Any mattress that helps a person sleep well, so that he/she awakes feeling rested and refreshed, without pain or stiffness, is the best mattress for that individual.

Mattress Composition The following physical components are the important features of most high-quality mattresses:

Spr

ucts have become life saving products for the pharmaceutical companies who doesn’t have many innovative molecules in their product pipeline and have been inc

ings and Coils These give firmness for back support. The wire in the coils can be varying thicknesses. Lower gauge wire is thicker and stiffer, meaning the mattress is firmer. A greater quantity of coils indicates a higher-quality mattress. Mattress Padding This is the part that provides comfort. Padding is usually made of polyurethane foam, puffed-up polyester, or cotton

easingly used in the product life cycle management. Even the companies having product patents are trying to extend their product life cycle through the combi

batting. Some mattresses have a foam layer just below the quilted top layer. Softer foams feel almost moist to the touch, and firmer foams do not spring back as quickly. Below this layer, there is a layer of cotton batting that caused the mattress to feel firmer in areas such as the middle of the mattress. Finally, there is an insulation layer that lies on top of the coil sp

nation products and maximize the revenues. But the companies involved in this practice are overlooking that they are burdening the patients both economically

ings so that they cannot be felt from the top of the mattress. It also protects the coils from damaging the top layers.

Mattress Ticking and Quilting The outer layer of a mattress is the ticking, a polyester or cotton-polyester blend. The mattress quilting attaches the ticking to the top layers of padding. A good quality mattress has consistent, unbroken stitching.

Box Spr

and physically. They need to rightly judge the benefits of the combination products and they have to even look at the risks involved when combining the produ

ing The box spring adds another level of support to the mattress. They usually consist of a wooden or metal frame with springs. Plain wood frames make mattresses feel harder than one with springs. Purchasing a mattress and box spring as a set maximizes the life of the mattress.

Foam Mattresses Some other types of mattresses are made of latex foam or “memory” foam. These ca

ts. Some of the combination products were well accepted by physicians while others suffered. Companies involved in development of combination products are fi

be purchased in different densities—the higher the density, the more firm it is.

Mattresses for Specific Back Conditions In general, the two best sleeping positions are either on your back with a pillow under your knees (to keep stress off the lower back), or on your side with a pillow between your knees (to keep your hips and lower spine aligned). Sleeping on your stomach

ding difficulty in defining their combination products and facing various challenges from selecting a combination to marketing it.

Following aspects would a

is not recommended. It places a lot of stress on your lower back and torque on your neck, since you have to keep your head turned to breathe. Also, you should not sleep with your arms above your head, as this can irritate the brachial plexus, a sensitive nerve bundle between your neck and shoulder.

People with degenerative spondylolisthesis or osteoarthritis may prefer an a

dd to the challenges in developing combination products:

Which markets to tap where the combination products can do fairly well?
Which combination prod

djustable bed (one that is at a slight incline) as it minimizes joint compression. This type of bed may also be helpful for those who suffer from gastroesophageal reflux (GERD). Patients who have hip bursitis (inflammation of the bursa over the hips) are especially susceptible to pain from a mattress that is too firm. Thick pillow tops or egg crate mattress pads may provide s

cts are meaningful and rational?
Which therapeutic categories to select?
Which Combinations can address unmet needs of the patients?
Do combin

me relief.

Tips for Buying a Mattress 1. Personal preference is the ultimate determination. Choose a mattress that meets your own standards for comfort and support. 2. Inquire about the physical components of the mattress, including number and arrangement of coils, padding thickness, and mattress depth. 3. Find a balance between back support and comfort. If a mattress is

tions increase the patient compliance?
What would be the developing cost?
How to tackle the risks encountered during combination product developmen

supportive, but not comfortable, it will not help your sleep. 4. Know when it is time to buy a new mattress. Most mattresses have a life span of about 7 years. If a mattress sags in the middle or if it is no longer comfortable, it is time for a new mattress. Putting a board under a sagging mattress is only a short-term fix. 5. Shop for value and quality, not price. High qu

t?

As combination products don't fit into the traditional categories of drugs, medical devices, or biological products, the USFDA is in the process of devel

lity mattresses are worth the investment if you consider the savings on health-care costs and greater productivity when getting pain-free, restful sleep. Mattress stores often have sales and promotions, so comparison-shop after choosing what mattress you would like. 6. Test-drive your mattress. Sleep on different mattresses in hotels or at friends’ homes. When at the store,

ping new procedures for reviewing their safety, efficacy and quality.

Professional from academic institutions, pharmaceutical industries, health care indust

lay on the mattress with your shoes off for at least ten minutes. If two people will be sleeping on the same mattress, do this together to make sure you are both comfortable. 7. Shop for the best customer service. Consider delivery options, old mattress removal policies, warranty, and return policies. Give high preference to stores that will let you return the mattress with

y and representatives from various regulatory agencies are working out to design the regulatory requirements for manufacture and sale of combination products

in two to four weeks if you are not satisfied. 8. Take good care of your mattress. Mattresses should be rotated every six months, both turned 180 degrees and flipped lengthwise.

Getting a good night’s rest is very important. A simple change in your mattress may make the difference between waking with back pain and waking rested and refreshed.

If you have any questions abou

.

As there is an increasing trend of the combination products companies manufacturing such products should be able to tackle the problems involved in the de

how to choose a new mattress, please feel free to contact Dr. Heller at (414) 774-2300.

References: “Composition of a High-Quality Mattress”, www.spine-health.com.

Dermody, Cynthia.“Firm Mattress News”; Reader’s Digest.

“Mattresses for Back Conditions.”, www.spine-health.com/topics/cd/mattress/mattress02.html.

“Mattress Guidelines for Sleep Comfort“, www.spine-health.co

elopment. They need to be wiser in analyzing the market trends and the regulatory requirements.

Companies that provide selfless information through particip

m/topics/cd/mattress/mattress01.html

Miller, Ron, PT.“Review of Adjustable Beds”, www.spine-health.com/topics/conserv/bed/bed01.html.

Staehler, Richard, MD.“Best Mattress for Low Back Pain”, www.spine-health.com/topics/conserv/mattress/mattress01.html

“Understanding the Best Mattress for Low Back Pain”, www.spine-health.com/topics/conserv/mattresschose/mattresschose01.html

tion in industry events and feedback to regulatory authorities would be able to face the challenges and will be successful in developing combination products

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