The product: The human spine is an amazing piece of equipment: On request, it can sway gracefully or withstand thousands of pounds of force. But that versatility comes with a price. At some point, just about everyone suffers significant back pain, and ends up searching for relief.
Back pain usually fades with time, but not everyone is willing to wait. When pain flares up, lots of people head to the drugstore -- more specifically, to the foot-care section.
Thanks largely to television ads from Dr. Scholl's, over-the-counter foot insoles are a popular accessory for people with back pain. The inserts cushion the feet and absorb some of the spine-rattling shock that comes with each step. Users hope that the extra protection will bring relief to their backs as well as their feet.
Dr. Scholl's (part of the large drug company Schering-Plough) sells several varieties of shoe inserts. According to the company website, three types are especially helpful for back pain: Back Pain Relief, Tri-Comfort and Extra Support. The Back Pain Relief insoles feature a "comfort spring" in the heel that's supposed to work like a little shock absorber. The Tri-Comfort model is designed to provide extra cushioning to the heel, arch and ball of the foot. The Extra Support insoles are built for heavier users. Each pair costs about $10.
The claims: In a current TV ad for Dr. Scholl's Back Pain Relief insoles, a grimacing man hobbles into his bathroom and reaches for pills in his medicine cabinet. The voice-over says, "Back pain? You don't just have to rely on pain relievers. Now you can take two of these." On cue, a pair of insoles pop out of his medicine bottle. The ad goes on to say the insoles are "clinically proven" and will "absorb jarring shocks with every step you take."
Charlie Lundy, associate director of product development for Dr. Scholl's, says that the insoles are especially helpful for people who are on their feet all day.
He also says that an unpublished company study of 57 people with back pain found that all three types of insoles provided significant relief after two weeks of use. "Some people got a lot, and some people got a little bit," he says.
The bottom line: Cushioned insoles may give a break to tired feet, but the back is another matter entirely, says Dr. Nick Shamie, assistant clinical professor of orthopedic surgery and neurosurgery with the UCLA Comprehensive Spine Center. "If a patient asked me about insoles, I would say, 'It won't hurt. Go ahead and try it,' " he says. "But there's no evidence to support the claims."
A 2007 report in the influential Cochrane Database of Systematic Reviews was a blow to anyone pinning their hopes on insoles. After pooling results of six published trials of insoles and back pain, the review authors concluded that there was "strong evidence that insoles are not effective for the prevention of back pain." They also said there aren't enough data to say if insoles help relieve back pain once it starts.
Shamie says the back goes through insults every day that have nothing to do with feet. Working against gravity to keep the body upright is a major job, especially if a person carries a few extra pounds. Strain in the back muscles is the most common source of low back pain, he says, and those muscles are barely affected by the force of feet hitting the ground.
Andrew Shapiro, a podiatrist in Valley Stream, N.Y., and a spokesman for the American Podiatric Medical Assn., agrees extra cushioning in the feet isn't likely to relieve back pain. "These things don't do anything biomechanically for the body," he says. High arches and flat feet can sometimes set off a reaction that puts stress on knees and back, but you'd need custom-fit orthotics to address such conditions, he says.
Lundy is aware of such criticisms and is also familiar with the Cochrane report. But he is confident that the insoles live up to the claims. "We're a pharmaceutical company, and we treat [insoles] like a drug product in the way we test them."