The TV advert guarantees ache aid for knee osteoarthritis, the supply of a lot of the 600,000 knee alternative surgical procedures carried out within the US annually. A person in a bowling alley winces with ache. He almost falls as he rolls a ball into the gutter. (Did I point out the arrow protruding of his knee?)
“Knee performing up once more?” asks his buddy, clearly involved. When ache drugs don’t appear to assist, his buddy suggests a process referred to as Coolief for knee osteoarthritis.
“I had it finished six months in the past,” says the bowling buddy. “And one of the best half is that it lasts as much as one yr.”
Coolief is a process, not a capsule. A physician inserts electrodes via the pores and skin, inserting them close to nerves in a number of areas across the knee. Electrical present utilized via the electrodes delivers warmth to the nerve. This impairs its capability to ship ache alerts to the mind.
Commonplace nerve blocks use an analogous methodology to dam ache alerts. However Coolief doesn’t simply warmth up the electrodes, it cools them down – a method referred to as “cooled radiofrequency ablation.” The concept is to ship extra power the place it’s alleged to go together with much less collateral harm.
The process is taken into account minimally invasive. Nevertheless, it requires a number of injections and x-ray steerage to make certain of the correct location. By comparability, a cortisone shot within the knee to alleviate ache is normally just one injection, and x-ray steerage isn’t wanted.
Does Coolief work?
Quite a few research have tried to reply this query, however the proof is iffy. In keeping with a recent review of previous research, the proof supporting cooled radiofrequency ablation as a dependable and long-lasting solution to relieve ache from knee osteoarthritis is kind of restricted. Many research included just a few sufferers and didn’t assess response after quite a lot of weeks.
Right here’s a fast rundown of a few of the largest and most up-to-date research:
- A 2015 study of 9 individuals with osteoarthritis receiving cooled radiofrequency ablation reported enchancment in measures of ache and performance “past one yr,” however particular particulars, together with how many individuals improved, weren’t supplied.
- A 2017 study of 33 individuals discovered successful fee of solely 35% six or extra months after remedy.
- A 2018 study of 151 individuals in contrast cooled radiofrequency ablation to having a single cortisone shot. After six months, 74% of people that had the process reported a discount in ache by at the very least half. An identical enchancment was reported by solely 16% of these receiving a cortisone injection.
What else do you have to think about?
Most research discovered few or no unintended effects related to the Coolief process. Even so, the producer warns of potential dangers that embrace an infection, nerve harm, elevated ache — even paralysis and dying. Partially, this can be primarily based on experiences of cooled radiofrequency ablation in different areas of the physique.
One draw back that’s price emphasizing is price: according to an NBC News story about this remedy, it could actually price $2,000 to $four,000, and might not be lined by medical health insurance.
Are the advertisements correct?
Based mostly on the 30-second TV industrial described above and a six-page on-line brochure, a few of the claims appear exaggerated, deceptive, or incomplete. For instance:
- A serious advertising and marketing level of Coolief is that it lasts as much as a yr. But, proof exhibiting such long-lasting enchancment in ache, perform, and high quality of life is kind of restricted. I may discover just one revealed report (the 2015 examine talked about above) that monitored handled people for a yr. It adopted solely 9 sufferers, three of whom had already had knee alternative surgical procedure. No particulars have been supplied on how lengthy enhancements lasted for particular person sufferers. Additionally, the examine cited by the net advert as proof for the one-year declare truly monitored sufferers for less than 12 weeks. One other examine of long-term outcomes is “obtainable upon request” from the corporate advertising and marketing Coolief.
- Some proof cited to help utilizing Coolief for osteoarthritis of the knee comes from remedy of hip and backbone ache. One examine cited as proof of long-term profit didn’t even use cooled radiofrequency ablation — it used an ordinary nerve block. And lasted solely 12 weeks.
- The net advert repeatedly reminds the reader that Coolief isn’t an opiate, and that we’d like non-opiate choices to deal with ache given the dangers and unintended effects of opiates. That’s true. However different statements aren’t true. Opioid prescriptions are not given to sufferers as a first-line remedy for power ache. Nor has aid from osteoarthritis knee ache relied on a each day routine of prescription opioid treatment. Actually, as a result of osteoarthritis of the knee tends to have an effect on older adults who’re vulnerable to treatment unintended effects, and since opiates include a number of dangers and unintended effects, physicians are likely to keep away from opiates in these sufferers.
- The net advert describes the Coolief process as “minimally invasive” and cortisone injections as “invasive.” Actually, they’re each minimally invasive.
Lastly, studying that Coolief was “cleared” by the FDA would possibly lead you to imagine the FDA evaluated the proof and concluded this process is secure and efficient. Actually, Coolief didn’t require particular FDA approval as a result of the FDA concluded it was comparable sufficient to different “legally marketed” units.
The underside line
Coolief could be useful for some individuals with osteoarthritis of the knee. Or it may not. Earlier than I like to recommend this costly process, I’d wish to see extra and higher research. The advertisements are dramatic and eye-grabbing, simply as they’re meant to be (see my blog on direct-to-consumer ads). Sadly, the proof supporting the advantages of this product isn’t almost so spectacular.
When you have osteoarthritis of the knee, speak to your physician about all of the choices, together with cooled radiofrequency ablation. And should you see an arrow protruding of your knee, cease bowling and search fast medical consideration.