Amid the countless challenges surrounding the treatment of scoliosis, the initial challenge comes with trying to diagnosis it. The most important part of the scoliosis diagnosis is that the curve is detected at a young age.
“The key is early detection,” James Wynne, CPO, vice president and director of training and education, Boston Brace, said. “The main issue is catching the curve early enough so we can influence the natural history. Sometimes that is simply the logistics of getting to the right medical professional in time so the treatment plan can be put in place.”
Detection of scoliosis
One of the most common ways to detect scoliosis is during a screening performed by a child’s school nurse. Although this method is effective, not every state in the US mandates that screenings be performed in schools, and the cost and lack of proper tools can also be problematic.
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“School screening is a common method, but not every state requires it,” Don Katz, CO, LO, FAAOP, vice president of Facilities and Process Design at Texas Scottish Rite Hospital for Children, told O&P Business News. “I think it would improve the screening method if school nurses had access to scoliometers, which would improve overall accuracy. However, not many schools will fund a scoliometer, and in some school screenings, the nurse is not allowed to actually touch the patient, and you need to do so to do a scoliometer measurement.”
Wynne echoed Katz’s concerns, adding that basic education regarding treatment options and when to treat is poor.
“We need more evidence, like the recent Katz study that support the efficacy of treatment. There are schools of thought that question conservative treatments,” he said.
Another common detection method is by a child’s primary care physician during his or her annual physical, but the declining number of children actually being seen by a primary care physician presents another challenge. And even if a child does receive regular physical examinations, there is also a chance that the curve will not be present yet.
Jose Miguel Gomez
“The time that scoliosis will typically present itself will be during a growth spurt,” Katz said. “So you could have a child that might show no signs of scoliosis during their March physical, but could develop scoliosis in the next 6-9 months that could require treatment before the next visit to his or her primary care physician.”
More commonly, a curve will be detected by a child’s parent or relative.
“Scoliosis is usually caught during the summer when a child is in a bathing suit and the parent looks at the child and notices something is going on,” Lynne Galonek, CPO, said.
Regardless of how a curve is detected, it is crucial that scoliosis is caught early and the child receives prompt medical attention.
“There are many cases of developing scoliosis that are not properly diagnosed, and unfortunately, the deformity is more aggressive as it increases,” Jose Miguel Gomez, MD, LO, president of Gomez Orthotic Systems, LLC, said. “So treatment is going to be more and more difficult as the scoliosis gets bigger and more involved.”
Once a curve has been detected, a treatment plan will be prescribed based on the degree and type of the curve and how much growth the patient has remaining.
Scoliosis, which affects 2% to 3% of the US population, is divided into four categories: infantile, 0-3 years; juvenile, 3-9 years; adolescent, 10-18 years; and adult. Within those categories, the deformity is categorized by the type and location of curve: thoracic, lumbar, thoracolumbar and either C-shaped or S-shaped.
If the curve is less than 25°, typically the patient is observed as he or she grows, and if the curve does not progress, no further treatment will be needed. If a curve is between 25° and 50º, orthotic bracing is typically utilized, and if the patient’s curve is 50° or higher, surgery is discussed.
“When a treatment decision is being made, the prescribing physician needs to ask him or herself, ‘What is the curve size and pattern that I am seeing, what is the location of the curve and the amount of resultant deformity present, and how much growth do I expect the child has remaining?’” Katz said.
“The main goal is to make sure that the spine is going to be stable for the rest of the patient’s life without surgery, and that will take, in some cases, more time than other patients,” Gomez said.
Approximately 80% of patients affected have adolescent idiopathic scoliosis, and in these situations, orthotic bracing is typically encouraged. If orthotic bracing is prescribed, a patient will first need to be fitted for his or her device.
The traditional method for creating an orthosis involves casting a plaster mold and then fabricating the orthosis based on the mold and the clinician’s measurements. However, advances in CAD/CAM technologies are beginning to replace this technique.
“Scoliosis is a three-dimensional deformity, and in order to treat three dimensions, you have to have the freedom to manipulate the mold in three dimensions,” Gomez said.
Based on this idea, Gomez created the Gomez Orthotic Spine System, which utilizes CAD/CAM technologies to take measurements of patients.
“These days, I do not cast patients. I take special, full-body pictures of the patients, along with X-rays and specific measurements using CAD/CAM systems,” Gomez said.
“There are a number of three dimensional deformities that we have to take into account in our brace design, and we find that used CAD offers a wide range of abilities to address each of those planes of deformity,” Katz said. “It is more challenging to rely just on your hands and a casting.”
Digital scanning also creates a permanent electronic file of a patient’s complete history. These digital files enable a clinician to easily access a patient’s file if a brace needs to modified and eliminate the need to store files and casts that may take up valuable space in an office or clinic.
“There is no way to take records of every modification on a plaster mold,” Gomez said. “With CAD files, if you are treating the same patient for many years, you will be able to see how you are changing or improving or modifying those files. It’s much more reliable.”
Digital scanning is also much easier and more comfortable for the patient, because he or she will not need to endure the lengthy casting process. However, if a clinician is uncomfortable using digital technologies, Galonek has another solution.
“I do not cast every patient. I only cast my neuromuscular patients,” Galonek said. “It would be awesome to cast every kid, but it’s not time efficient.”
Instead, Galonek takes a series of approximately 25 to 30 measurements of the patient, which she sends to Spinal Technology, Inc., a manufacturer of spinal orthoses in West Yarmouth, Mass.
“They have a warehouse of models and will pull the one that is most similar to my measurements and modify it,” Galonek said. “So it’s still a custom brace, but I do not have to cast every time.”
According to Galonek, she still achieves positive results despite not casting her patients.
The most commonly used orthosis is the Boston Brace, a symmetrical thoracolumbosacral orthosis (TLSO) made from thermoplastics, but asymmetrical orthoses and nighttime orthoses are also used.
“Regardless of the name of the orthosis, it is the competence of the fabrication facility and the treating orthotist to understand the biomechanical principles of that specific brace design. The fitting and follow-up of the patient and time spent educating the parents and patient is also a critical part of a successful program. For patients to be compliant they need to understand their role in the treatment,” Wynne said. “The name just describes a type of brace.”
After an orthosis has been fabricated, the child usually returns after 4 weeks for an in-brace X-ray. The X-ray will indicate if the orthosis is delivering the anticipated corrections. The orthotist can then make further modifications if necessary.
CAD/CAM technologies can possibly simplify this process as well. According to Wynne, a program is currently being tested in Montreal that can predict the correction an orthosis will deliver before it is fabricated.
“Currently, we design the brace according to the biomechanical principles and our experience. We then fit the orthosis and analyze the in-brace X-ray and adjust after the fact,” Wynne said. “Now we are going to be able to do all of that on the front end.
“We are utilizing a test simulator called the brace sim where you will be able to take a scan of the patient, import the the digital X-ray and generate a 3-D model of the patient’s spine. CAD modifications are made to the model and tested, and the orthotist can then make changes to the model to optimize the result,” Wynne said.
Once all the information is collected, the program will forecast the amount of correction that will be achieved by the brace, and the brace can then be modified within the program to attain ideal correction.
“We will be able to test the design and modify prior to the brace going to fabrication,” Wynne said. “Then when we have the ideal design, we can fabricate it knowing what the predicted results are.”
Once a child is fit with his or her orthosis, the next challenge is determining the amount of time that it should be worn. Although wear time depends on the type and degree of the curve, debate persists over whether children should wear an orthosis 23 hours a day, 16 hours a day or only at night.
“We published a paper in the 1990s in the largest series to date looking at what curves may be comparably treated with a brace specifically designed to be only worn at night versus a brace designed for upright wear to be worn during the day,” Katz said. “We found that in a growing child with a single lumbar or thoracolumbar curve that is 35° or smaller, the child can be treated as successfully with a brace designed for nightwear only.”
Galonek said that she often advocates for the use of a nighttime orthotic as well.
“I have kids that only wear their brace at night, even though I recommend 23 hours a day,” Galonek said. “So if they are only wearing it at night, I might as well push on them as hard as I can with a nighttime, overcorrective brace. And we have gotten good results on quite a few kids.”
However, this option is not advised for all patients. If a patient has a more severe curve, it is usually recommended that he or she wear a daytime orthosis for anywhere between 16 to 23 hours a day.
“As far as the number of hours per day for those patients, there are different camps of thought,” Katz said.
In a study published by Katz, 100 prospectively treated patients at the Texas Scottish Rite Hospital for children were prescribed to either wear the orthosis 23 hours a day or 16 hours a day. The children’s wear time was measured with the use of a monitor that could document changes in temperature inside of the brace, and through the development of an extensive algorithm, actual wear patterns were then quantified and compared to treatment outcomes. All subjects were followed until they reached skeletal maturity as well as post-treatment follow up.
“When we compared the results, we found across the board that there is a dose response that the more a child wears the brace, the less likely the curve will get worse,” Katz said. “We also found that those who were prescribed 23 hours a day did not wear their brace significantly more than those that were prescribed 16 hours a day. Lastly, we found that those that were treated most successfully average at least 12 hours per day throughout treatment.”
Although Katz does not advocate prescribing that a child wears his or her orthosis 12 hours a day, the results present interesting information about prescribed wear time.
“Ever since that research was done and we found that there definitely was that dose relationship and braces can affect the natural history of an otherwise progressive curve and are effective, we also learned that a lot of patients don’t wear their brace as often as prescribed,” Katz said. “It wasn’t a surprise, but we were able to quantify that.”
Compliance is key
Arguably the biggest challenge when treating patients for scoliosis is compliance. According to Katz, the only way to truly measure compliance is with the use of compliance monitors, which the team at Scottish Rite has transferred into their clinical practice.
“We continue to offer the use of a monitor to many of our patients who are prescribed with an orthosis as long as they sign a consent form to participate that way,” Katz said. “It appears to be a great tool to be able to give a patient and their parents this level of objective feedback for their orthotic treatment.”
Although this technology is gaining popularity, not all clinicians have this ability. In this case, it is up to the clinical team to ensure that the patient is wearing the brace for the expected amount of time.
“It involves the entire family. I tell all of my kids, ‘I can’t be with you 23 hours a day, I can just tell you that I don’t want you to regret this 10 years from now,’” Galonek said.
Galonek is able to speak from personal experience, because she had scoliosis as a child and wore an orthosis for 5 years.
“I am honest and open with my patients and will tell them my own story. I feel that it does give me an advantage over other orthotists, because I wore that brace for 5 years, and I know what it feels like,” Galonek said. “I think a lot of the kids can relate to me.”
Although not all clinicians can relate to their patients on such a personal level, empathy is critical for working with this patient population.
“It is not easy wearing these things,” Wynne said. “Be empathetic and willing to listen to their concerns. Anything you can do to make the [brace] unique and put the child in control is going to help.”
Orthotists should also be willing to compromise with a patient about when he or she will wear the orthosis.
“We don’t want to make excuses every day for not wearing the brace, but we know that things come up,” Wynne said. “We will bargain with the kids. So if there is a camping trip or school dance, maybe those times they won’t wear the brace, but they need to make up for it somewhere else.”
Compliance issues also stem from cosmetic concern and how an orthosis will look under the patient’s clothing.
“We have an obligation as orthotists to design braces that are as tolerable as possible to the patient, so it is important that we ask what the biggest challenges are for the patient,” Katz said. “If they tell you, ‘I hate wearing it because you can see it through my clothes,’ then maybe there is something that we can change in the design to make it more cosmetic and acceptable.”
Wynne explained a partnership with a local Nordstrom department store, where patients could attend a fashion show and learn about ways to conceal the orthosis through fashion.
“We run the fashion show twice a year, and people come in and show the kids layering techniques and how they can hide the brace underneath clothing,” Wynne said. “Outreach and things like that have a really positive influence.”
Ultimately, the patient, along with the patient’s family and support system, must be educated about the goals for wearing the orthosis and understand the consequences of not wearing it.
“The most important part is that you treat the patient like he or she is the most important member of the team,” Gomez said. “Explain what to do and what to expect. The patient needs to understand what is going on because they are the ones wearing the brace every single day.”
When a child reaches skeletal maturity, which is determined by the amount of calcification on the pelvis, he or she typically discontinues use of the orthosis and will usually require no further treatment. However, despite the use of an orthosis, about 20% to 25% of patients will need surgery to fully correct the curve, according to Katz.
“Despite the fact that we know braces can be effective in most patients, we can never estimate or ever suggest that they will have 100% efficacy,” Katz said. “If every child wore his or her brace with diligence, there will still be some that can relentlessly progress despite that.”
Galonek agreed, saying that despite a child’s best efforts, sometimes a curve will progress anyway.
“I tell all of my kids, I will try my hardest to stop your curve from progressing. And I will push on your spine as hard as I can as long as you wear this brace,” Galonek said. “But sometimes a curve has a mind of its own, and it’s going to progress no matter how hard we push.”
In those situations, surgery is usually discussed with the patient and the patient’s family, but the decision to operate is usually left up to the patient.
Due to the individualized and unpredictable nature of scoliosis deformities, the debate about efficacy of orthoses may never be truly settled. However, evidence suggests that bracing is beneficial and orthotists should continue working to improve these devices.
“It was so important in our study that we monitored how much a child actually wore the brace, because we found those that wore their brace most effectively completely avoided the need for surgery,” Katz said. “It’s pretty strong evidence that braces work and are effective, but we still have a lot to do in determining how to make them more tolerable and increase compliance.” — by Megan
For More Information:
Katz DE. JBone Joint Surg Am. 2010;92:1343-1352.
Disclosures: Gomez is the president and developer of Gomez Orthotic Systems, LLC. Wynne is the vice president and director of training education for Boston Brace. Katz had no relevant disclosures. Galonek works for Wright and Filippis.