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Exercise and Bracing for Scoliosis, But Where Is Chiropractic?



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July 13, 2011

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The prevalence of scoliosis differs with age and race but it is estimated to be between “1% to 2% among adolescents, but more than 50% among persons over age 60”.  Scoliosis is usually defined by a 10 degree or greater curve in the spine as demonstrated on plain AP X-ray.  The body of knowledge has grown substantially during the last decade in support of conservative management of scoliosis both through bracing and exercise. In one of the most recent studies (May 2011), patients with scoliotic curves in excess of 45 degrees declined surgery and elected to enter a trial of only bracing.  This conservatively treated group had statistically significant improvement in average thoracic and lumbar curves.  The authors concluded that “Bracing can be successfully used in patients who do not want to undergo operations for IS with curves ranging between 45° and 60° Cobb, given sufficient clinical expertise to apply good braces and achieve great compliance. Future studies could demonstrate the percentages at which this result can be achieved.” Most bracing has been used to limit the progress of scoliosis so this study offers promise to actually reduce the scoliotic curve without surgery.

In conducting literature searches for studies completed in the last couple of years supporting chiropractic care for scoliosis, the only published works found were a few case reports.  Based upon these very limited studies along with antidotal comments by those that focus their practices on scoliosis, it is regrettable that the profession has not been able to conduct more research in this area.  Limited funds and the limited number of clinical researchers continue to create professional challenges.

Free full text of a 2011 literature review of scoliosis can be found here.

Note:  These mini-reviews are designed as updates and direct the reader to the full text of current research.  The abstracts presented here are no substitute for reading and critically reviewing the full text of the original research.  Where permitted we will direct the reader to that full text.

Idiopathic scoliosis patients with curves more than 45 Cobb degrees refusing surgery can be effectively treated through bracing with curve improvements.  [Link]

Spine J. 2011 May;11(5):369-80. Epub 2011 Feb 2.

Negrini S, Negrini F, Fusco C, Zaina F.
Rehabilitation Department, ISICO (Italian Scientific Spine Institute), Via Bellarmino 13/1, 20141 Milan, Italy.

BACKGROUND CONTEXT: It is a broad consensus today that scoliosis curves cannot be improved through bracing, and the Scoliosis Research Society (SRS) methodological criteria for bracing have the avoidance of progression as their only objective. Consequently, in curves more than 45°, fusion is considered as basically the only possible treatment.

PURPOSE: The purpose of the study was to verify in a series of patients who utterly refused surgery if it was possible to achieve improvements of scoliosis of more than 45° through a complete conservative treatment (bracing and exercises).

STUDY DESIGN/SETTING: Retrospective cohort from a prospective database.

PATIENT SAMPLE: Out of 1,148 idiopathic scoliosis (IS) patients at the end of treatment, the sample comprised 28 subjects older than 10 years, still growing, with at least one curve above 45°, who had continually refused fusion. The group comprised 24 females and four males, including 14 in which previous brace treatments had failed; at the start of treatment, the age was 14.2±1.8 years and Cobb degrees in the curve were 49.4° (range, 45°-58°). Subgroups considered were gender, bone age, type of scoliosis, treatment used, and previous failed treatment.

OUTCOME MEASURES: Self-report measurement: SRS-22; physiological measures: Cobb degrees, Bunnell angle of trunk rotation (ATR), aesthetic index (AI), and sagittal plumb line distances. METHODS: The methods comprised full-time treatment (23 or 24 hours per day) for 1 year with Risser cast, Lyon, or Sforzesco brace; weaning of 1 to 2 hours every 6 months; with strategies to maximize compliance through the Society on Scoliosis Orthopaedic and Rehabilitation Treatment (SOSORT) management criteria applied and specific scientific exercises approach to scoliosis exercises (SEAS) performed.

RESULTS: Reported compliance in the 4.10±1.2 treatment years was 94%, with satisfaction regarding treatment and excellent results at the SRS-22. Two patients (7%) remained above 50° Cobb but six patients (21%) finished between 30° and 35° Cobb and 12 patients (43%) finished between 36° and 40° Cobb. Improvements have been found in 71% of patients and a 5° Cobb progression in one patient. Statistically, we found highly significant reductions of the main (-9.25°), average (-6.6°), thoracic (-7.8°), and lumbar (-15.9°) curves. Statistically significant improvements have been found for the AI and ATR, with a general decrease in plumb line distances.

CONCLUSIONS: Bracing can be successfully used in patients who do not want to undergo operations for IS with curves ranging between 45° and 60° Cobb, given sufficient clinical expertise to apply good braces and achieve great compliance. Future studies could demonstrate the percentages at which this result can be achieved.


Physical exercises in the treatment of adolescent idiopathic scoliosis: an updated systematic review.  [Link]

Physiother Theory Pract. 2011 Jan;27(1):80-114.

Fusco C, Zaina F, Atanasio S, Romano M, Negrini A, Negrini S.
ISICO (Italian Spine Scientific Institute), Milano, Italy.

Two years ago we published an update of another of our previous systematic reviews about the effectiveness of physical exercises (PEs), and we found that the evidence on exercises for AIS was of level 1b. Now we have updated these results in the field of exercises for AIS with the final aim to find the strongest evidence as possible about PEs. Our goal was to verify if treatment with specific exercises for AIS has changed in these years. The study design was a systematic review. A bibliographic search with strict inclusion criteria (patients treated exclusively with exercises, outcome Cobb degrees, all study designs) has been performed on the main electronic databases. We found a new paper about active autocorrection (Negrini et al, 2008 b), a prospective controlled cohort observational study on patients never treated before so the number of manuscripts considered in the systematic review was 20. The highest quality study (RCT) compared 2 groups of 40 patients, showing an improvement of the curve in all treated patients after 6 months. All studies confirmed the efficacy of exercises in reducing the progression rate (mainly in early puberty) and/or improving the Cobb angles (around the end of growth). Exercises were also shown to be effective in reducing brace prescription. Appendices of the popular exercise protocols that have been used in the research studies that are examined are included with detailed description and illustrations. This study (like the previously published systematic reviews) showed that PEs can improve the Cobb angles of individuals with AIS and can improve strength, mobility, and balance. The level of evidence remains 1b according to the Oxford Centre for Evidence-based Medicine, as previously documented.


Effectiveness and outcomes of brace treatment: a systematic review.  [Link]

Physiother Theory Pract. 2011 Jan;27(1):26-42.

Maruyama T, Grivas TB, Kaspiris A.
Department of Orthopaedic Surgery, Saitama Medical Centre, Saitama Medical University, Kawagoe, Saitama, Japan. tmaruyama17@yahoo.co.jp

Bracing has been widely used for the treatment of adolescent idiopathic scoliosis (AIS). However, effectiveness of brace treatment remains controversial. A systematic review was conducted to investigate evidence that brace treatment is effective in the treatment of AIS. A total of 20 studies, including randomized controlled trials, nonrandomized clinical controlled trials, or case-control studies, were included. Studies comparing the results of brace treatment with no-treatment, other conservative treatments, or surgical treatment were included. Outcomes of the studies included radiological curve progression, incidence of surgery, pulmonary function, quality of life (QOL), and psychological state. The results from the systematic review are difficult to interpret. There are quite a number of varying parameters between studies that make it very difficult to reach any firm conclusions. In addition, the quality of evidence is limited because most of the studies included in this review were of low methodological quality. However, the available data suggest that, compared to observation, bracing is more potent in preventing the progression of scoliosis and may not have a negative impact on patients' QOL. Therefore, bracing can be recommended for the treatment of AIS, at least for female patients with a Cobb angle of 25-35°. Compared to other conservative treatments, bracing seems to be more effective than electrical stimulation, although an advantage of bracing over side-shift exercise or casting has not been established. Comparison between bracing and surgery is difficult because in most studies, the curve magnitude at baseline was considerably larger in the surgery group. We recommend that future studies have clearer and more consistent guidelines.


Effectiveness of Chêneau brace treatment for idiopathic scoliosis: prospective study in 79 patients followed to skeletal maturity.  [Link]

Scoliosis. 2011 Jan 25;6(1):2.

Zaborowska-Sapeta K, Kowalski IM, Kotwicki T, Protasiewicz-Faldowska H, Kiebzak W.
Department of Pediatric Orthopedics and Traumatology, University of Medical Sciences, Poznan, Poland. kotwicki@ump.edu.pl.

BACKGROUND: Progressive idiopathic scoliosis can negatively influence the development and functioning of 2-3% of adolescents, with health consequences and economic costs, placing the disease in the centre of interest of the developmental medicine. The aim of this study was to evaluate the effectiveness of Chêneau brace in the management of idiopathic scoliosis.

METHODS: A prospective observational study according to SOSORT and SRS recommendations comprised 79 patients (58 girls and 21 boys) with progressive idiopathic scoliosis, treated with Chêneau brace and physiotherapy, with initial Cobb angle between 20 and 45 degrees, no previous brace treatment, Risser 4 or more at the final evaluation and minimum one year follow-up after weaning the brace. Achieving 50° of Cobb angle was considered surgical recommendation.

RESULTS: At follow-up 20 patients (25.3%) improved, 18 patients (22.8%) were stable, 31 patients (39.2%) progressed below 50 degrees and 10 patients (12.7%) progressed beyond 50 degrees (2 of these 10 patients progressed beyond 60 degrees). Progression concerned the younger and less skeletally mature patients.

CONCLUSION: Conservative treatment with Chêneau orthosis and physiotherapy was effective in halting scoliosis progression in 48.1% of patients. The results of this study suggest that bracing is effective in reducing the incidence of surgery in comparison with natural history.


Bracing for adolescent idiopathic scoliosis in practice today.  [Link]

J Pediatr Orthop. 2011 Jan-Feb;31(1 Suppl):S53-60.

Sponseller PD.
Department of Orthopaedic Surgery, The Johns Hopkins University, Baltimore, MD 21224-2780, USA. ehenze1@jhmi.edu

BACKGROUND: The use of orthoses in adolescent idiopathic scoliosis has a long history. The purpose of this article is to summarize the current practice of bracing in the treatment of adolescent idiopathic scoliosis.

METHODS: The literature from the past 25 years was reviewed for primary papers that contained accepted inclusion criteria for bracing, meta-analyses, and summaries of existing opinion. Recent literature was also reviewed for current bracing practices.

RESULTS: The highest level of existing evidence comes from a prospective center-randomized study by Nachemson et al, which showed that bracing was effective for single curves of 25 to 35 degrees in female patients with a starting Risser score of 0 to 2. Two other studies with meta-analyses came to opposite conclusions because of variations in the examined investigations. Although there are few studies that compare different types of treatment, most show an improved outcome versus historical controls. The yearly number of peer-reviewed papers on the topic has increased markedly over this time. Two prospective randomized multicenter trials are underway. Reviews suggest that most orthopaedic specialists recommend bracing but that they differ on expected results. There is also a proliferation of interest in bracing by nonorthopaedists, with more varied indications. There are many types of full-time and part-time braces, and their designs and indications are described.

CONCLUSIONS: Brace treatment for adolescent idiopathic scoliosis continues to be frequently used, and the number of brace types has increased. Predicting progressive curves and refining indications requires additional investigation.


"Brace Technology" Thematic Series - The Lyon approach to the conservative treatment of scoliosis.  [Link]

Scoliosis. 2011 Mar 20;6:4.

de Mauroy JC, Lecante C, Barral F.
Clinique du Parc, 155 boulevard Stalingrad 69006 Lyon, France. demauroy@aol.com.

ABSTRACT: The Lyon Brace, or adjustable multi-shell brace, has been used for more than 60 years.The use and function of the Lyon Brace includes:- The utilization of one or two corrective plaster casts, which enables a true lengthening of the concave ligaments.- An oriented CAD-CAM moulding in 3D auto correction after the removal of the plaster cast.- A blueprint adapted to Lenke's classification.- A specific physiotherapy program.

BACKGROUND: Pierre Stagnara created the Lyon Brace in 1947. The brace has the following characteristics:- It adjusts to allow for a child's growth of up to seven centimetres and for an increase in weight of up to seven kilograms.- It is 'active' in that the rigidity of the PMM (polymetacrylate of methyl) structure stimulates the user to auto-correct. The active axial auto-correction decreases the pressures of the brace on the trunk.- It is decompressive in that the effect of extension between the two pelvic and scapular girdles decreases the pressure on the intervertebral disc allowing for more effective pushes in the other planes.- It is symmetrical making it both more aesthetically pleasing and easier to build.- It is stable at both shoulders and pelvic girdle, facilitating the intermediate 3D corrections.- It is transparent. The pressure of the shells on the skin can be directly controlled so "pads" are usually not necessary. BRACE

DESCRIPTION: Two metal bars are fixed vertically, one anterior the other posterior and all shells are attached from the bottom to the top in this order:- Two pelvic shells ensure an optimal stability of the brace.- One lumbar shell T12-L4, which can be either independent or extending, at the abdominal chondrocostal level.- One thoracic shell at the level of the thoracic convexity.- One opposite thoracic shell used as a counter push.- One shoulder balance shell on the side of the thoracic convexity.

LONG TERM FOLLOW UP RESULTS: This is a retrospective study of 1,338 completed treatments checked a minimum of two years after weaning from the brace.Only 5% of the curves progressed more than 5° from the initial magnitudes. This translates to an effectiveness index of 0.95.A subset of 174 subjects who started treatment at Risser 0 was isolated. The global progressive angular mean curve was superimposed on the statistic general curve and the effectiveness index was calculated at 0.80.The Surgery rate was just 2% of the patients presenting with an initial curve below 45°.

CONCLUSION: The Lyon Brace is the historical reference of bracing AIS. To be fully effective, it requires the patient to wear a plaster cast for at least one month and receive specific physiotherapy training. Although this is a retrospective study, the results are very positive, and clearly indicate a need for a prospective study.


Correlation Between Hump Dimensions and Curve Severity in Idiopathic Scoliosis Before and After Conservative Treatment.  [Link]

Spine (Phila Pa 1976). 2011 Jan 8. [Epub ahead of print]

Aulisa AG, Guzzanti V, Perisano C, Marzetti E, Menghi A, Giordano M, Aulisa L.
1Department of Orthopaedics and Traumatology, Children's Hospital Bambino Gesù, Institute of Scientific Research, P.zza S. Onofrio 4 -00165 Rome, Italy 2Department of Orthopaedics, Catholic University of the Sacred Heart, University Hospital 'Agostino Gemelli', L.go F. Vito, 1 - 00168 Rome, Italy 3Department of Aging and Geriatric Research, Institute on Aging, Division of Biology of Aging, University of Florida, Gainesville, FL 32610-0143, USA 4University of Cassino, Strada Folcare, 4 - 03043 Cassino (FR), Italy.

Study design: Prospective study in 150 consecutive outpatients affected by adolescent idiopathic scoliosis (AIS)Objectives. The purposes were to (1) identify a correlation between hump dimensions and the severity of scoliotic curve, and (2) evaluate how the treatment influenced the main parameters of scoliosis.

Summary of Background Data: The existence of a relationship between clinical deformities and curve severity in AIS is still debated. Furthemore, only a few studies have investigated the effectiveness of conservative treatment for idiopathic scoliosis taking into account both clinical and radiological factors.

Materials and Methods: 150 consecutive outpatients (mean age 12.8 ± 1.9 years) affected by AIS were subjected to conservative brace-based treatment. 134 participants completed the treatment protocol. Two parameters were considered to evaluate the treatment progress: the hump and the Cobb angle. Measurements were determined at the beginning and the end of treatment. Statistical analyses were performed in the whole sample and after dividing the study participants into 4 sub-groups: patients with lumbar (n=66) or thoracic curves (n=68), patients ranging in age between 6 and 13 years (n=89) and patients = 14 years of age (n=45).

Results: A positive correlation was detected between the hump dimension and curve severity at the beginning and the end of treatment, except for lumbar curves at baseline. The deformity was effectively corrected by the orthotic treatment (Cobb angle: 29.4 ± 8.5° at baseline and 19.3 ± 9.8° at the end of treatment; hump severity: 11.6 ± 5.6 mm at baseline and 6.2 ± 4.6 mm at the end). In addition, our data indicate that the hump correction is more evident than that of the curve registered in Cobb degrees.

Conclusions: A significant correlation exists between the hump dimension and curve severity both at the beginning and the end of treatment, except for lumbar curves at baseline. The brace treatment confirmed its effectiveness in arresting the deformity progression and inducing a remodeling both of the scoliotic curve and the hump.


Adolescent idiopathic scoliosis: Indications and efficacy of nonoperative treatment.  [Link]

Indian J Orthop. 2011 Jan;45(1):7-14.

Canavese F, Kaelin A.
University of Geneva Hospitals and Faculty of Medicine, Pediatric Orthopaedic Service, Department of Child and Adolescent, Rue Willy-Donzé, 6, 1211 Geneva 14, Switzerland.

The strategy for the treatment of idiopathic scoliosis depends essentially upon the magnitude and pattern of the deformity, and its potential for progression. Treatment options include observation, bracing and/or surgery. During the past decade, several studies have demonstrated that the natural history of adolescent idiopathic scoliosis can be positively affected by nonoperative treatment, especially bracing. Other forms of conservative treatment, such as chiropractic or osteopathic manipulation, acupuncture, exercise or other manual treatments, or diet and nutrition, have not yet been proven to be effective in controlling spinal deformity progression, and those with a natural history that is favorable at the completion of growth. Observation is appropriate treatment for small curves, curves that are at low risk of progression, and those with a natural history that is favorable at the completion of growth. Indications for brace treatment are a growing child presenting with a curve of 25°-40° or a curve less than 25° with documented progression. Curves of 20°-25° in patients with pronounced skeletal immaturity should also be treated. The purpose of this review is to provide information about conservative treatment of adolescent idiopathic scoliosis. Indications for conservative treatment, hours daily wear and complications of brace treatment as well as brace types are discussed.
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1 Comment on:

Exercise and Bracing for Scoliosis, But Where Is Chiropractic?

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Re:Exercise and Bracing for Scoliosis, But Where Is Chiropractic?


by drstitzel   (7/24/2011 2:46:37 PM)
Does Traditional Chiropractic Help Scoliosis? In 1997, Dr. Charles Lance of "The Chiropractic Foundation for Research" conducted a 3 year study to study the effect of traditional chiropractic spinal adjustments, heel lifts, and postural counsiling on mild scoliosis (scoliosis less than 20 degrees). Of the 150 children whom started the study, only 40 completed the entire 3 years and the average reduction of the scoliosis spine curve was only 1.4 degrees. Given the fact that the study cost over $143,000, the financial costs of $10,241 per degree is unacceptable and unaffordable.
Fresh all the heels of this studies completion, the scoliosis researchers and clinicians at the CLEAR Institute began work on a finding a better way to treat scoliosis.
In 2004, the CLEAR Institute held it's first seminar at Parker College of Chiropractic and unveiled the Scoliosis Traction Chair for the first time. This innovative scoliosis treatment methodology focuses on treating scoliosis primarily like a neurological condition that develops a spinal curvature as it's primary symptom, which is an evolutionary step forward in terms of scoliosis treatment philosophy.
Since that time, the CLEAR Institute has continued to innovate, discover, and improve the scoliosis treatment process and application. Today, most adolsecent idiopathic scoliosis patients are able to reduce their spinal curvatures by 30%-50% on average and maintain their spinal health/quality of life through out adulthood.
 
Scoliscore and CLEAR Institute Chiropractic Scoliosis Treatment On March 6, 2010 the leadership team of the CLEAR Institute met with the Scoliscore leadership team at the Axial Bio-Tech labs in Salt Lake City, Utah to explore how genetic testing combined with environmental influence reduction could improve scoliosis treatment. The result was the development of an entirely new scoliosis treatment paradigm in which genetic testing would determine the most appropriate course of treatment and early stage scoliosis intervention could eliminate the need for scoliosis brace treatment and scoliosis surgery in virtually all adolscent idiopathic scoliosis cases.
Genetic Pre-Disposition + Environmental Influences = Idiopathic Scoliosis
Anybody with even the most basic understanding of algebra can tell you that a problem with 2 unknown variables can not be solved, therefore the multi-factorial nature (genetics and environment) of each patient's case made treatment recommendations very difficult, uncertain, and inaccurate. This means doctors often over or under treated scoliosis patients and had very poor scoliosis treatment success rates. However, having the ability to accuately determine the patient's genetic pre-disposition allows doctors to select the most appropriate level of treatment invasiveness and re-evaluation time frames.
This is a very valid question, and one I have encountered many times. I consider myself to be analytical by nature, and I have always respected those who prefer hard data over personal stories. In my opinion, it is unfortunate that, in the realm of marketing, anecdotes and testimonials sometimes hold more appeal than facts and numbers.
So where is the research on CLEAR Institute Scoliosis Treatment?
By Dr. Josh Woggon.
Research is indeed an integral part of validating the efficacy of new treatment options as they become available. The new standard of Evidence-Based Medicine highlights the importance of utilizing the best available data from published, peer-reviewed articles, combined with the doctor’s clinical judgment and the specific needs of the patient. Since 2004, publishing research in scientific journals has always been a top priority of CLEAR Institute, and we maintain this commitment as our organization continues to evolve to meet the needs of our patients.

The article, “Scoliosis treatment using a combination of manipulative and rehabilitative therapy: a retrospective case series,” published by Drs. Morningstar, Woggon, & Lawrence in BMC Musculoskeletal Disorders, on September 14th, 2004, was a landmark in the realm of conservative scoliosis treatment. Within two years of its publication, it achieved the status of Most-Highly Accessed Article of All-Time in this journal, and continues to hold this title as of 2009, with over 36,000 views (number two has just under 24,000).

Limitations of this study have been recognized by the authors. Firstly, the design of the study is a Case Report, which essentially means that it was a retrospective review of how individual patients responded to 4-6 weeks of care. This study design limits the conclusions that can be made by the authors, and indeed, the only conclusion made was that the results of the study warrant further testing & research into the protocols. Another limitation is that there was no long-term follow-up demonstrating the permanence of the achieved results. It is important to state that CLEAR Institute has identified the need for continued research to address the short-comings of the first study, as well as the obstacles which need to be overcome in order to do so.

Our second study shares many of these limitations. Despite having a broader and more diverse sample size, it is also retrospective. A retrospective study looks back at the results of a certain number of individuals who fit the study criteria (such as having idiopathic scoliosis). A prospective study is probably what you would like to see, Bambi - in this type of study, the study criteria is expanded to include a time requirement (for example, every patient that started treatment from January 2010 until April 2010). In this manner, the rate of noncompliance ("drop-outs") can be included, and also the researcher has less control over the ability to self-select or "cherry-pick" the best results.

One of the greatest hurdles facing CLEAR Institute in the coming years is obtaining the necessary funding to pursue the long-term research into our technique, which is so desperately needed to establish confidence in the solidity & permanence of the achieved correction. It is an interesting side-note to point out at this time that, while the first spinal fusion surgery for scoliosis was conducted in 1911, and bracing has been around since the 17th century, many research reviews still consider the scientific evidence on these techniques to be inconclusive at best, despite the considerable resources wielded by the organizations advancing these techniques. CLEAR Institute, by contrast, was established less than a decade ago, in 2000, and did not begin working with scoliosis specifically until 2003. Coupled with the fact that CLEAR Institute is an organization primarily staffed by volunteers, most of them being clinicians who also maintain active private practices, it should be obvious that our financial & temporal resources are constrained to a much more significant degree.

CLEAR Institute has made an effort to ameliorate this difficulty by applying for Non-Profit Status in December of 2008, which will allow us to apply for & receive grant funding for proposed research endeavors. Unfortunately, like many bureaucratic processes, achieving formal recognition from the IRS as a Non-Profit Organization can take years even in the best of times. As of May of 2010, CLEAR Institute has not encountered any difficulties with its application; and has been granted provisional acceptance. Once this is formally & firmly in place, though, we will be able to submit research proposals & grant requests through a number of different organizations, including the Research Department of Parker College of Chiropractic, which is literally right next door to the CLEAR Scoliosis Treatment and Research (STAR) Clinic.

Please humor me by allowing me to expand briefly on some of various research study designs, and the benefits & limitations of each. I'll do my best to keep it as succinct as possible.

There may be considered three tiers of scientific articles. The first type, a Case Report, is merely observational. If a doctor or group of doctors notice an interesting case, or experience unusually good results in treating a common condition, they may draw up a Case Report to describe what they saw in their clinical practice. While relatively easy & inexpensive to produce, they allow the authors the least freedom to draw conclusions regarding the interpretation of the results, and are the most vulnerable to criticism regarding the validity of the results.

The second type is the Case Control or Cohort study, which can be prospective (designed in advance) rather than retrospective, but is still considered observational. In this type of study, two groups – one undergoing treatment, one not – are matched as closely as possible in terms of age, gender, severity of their condition, and similar factors. One group – the control – does not undergo any treatment, but are merely observed for how the condition progresses in the absence of care. The next group - the treatment or variable group – is the one which receives treatment, and at the end of the study, the two groups are compared. This allows for more specific data on the true effectiveness of the prescribed intervention, and thus the authors have more leeway to define the outcomes, but a Controlled study is subject to additional difficulties in its implementation. The first is the selection process; members of each group are self-selected (meaning they decide for themselves whether or not they would like to receive treatment), and screened for their eligibility. This process can take many months to refine the two groups into similarly-matched, and dozens of patients which may otherwise be ideal candidates for the study could be excluded for the simple reason that another patient matching their demographical profile cannot be found. Another limitation, common to all prospective studies, is the difficulty of maintaining patient compliance. It is inevitable that certain patients will drop out during the course of the study; if enough patients in the treatment group fail to keep their appointments, or if members of the control group do not come in for regularly scheduled check-ups, the entire study can be rendered invalid, and the results will be tossed.

The study design which is considered to be the most scientifically-sound is the Randomized Control Trial, or RCT. With the prospective design of a RCT, the patients in the treatment group & control group are not self-selected, but rather are randomly assigned to one of the two groups. Typically, the patients are not told (blinded) which group they will be in, and in a double-blind study (the most advanced form of RCT), even the doctors performing the study are kept ignorant of which patients are receiving the intervention and which are receiving a sham treatment or placebo, and even which patients have a disease and which do not (in conditions which are self-evident, such as scoliosis, these types of studies can be near impossible to design, however; doctors working with patients on a daily basis will soon be able to ascertain which ones have spinal deformities and which do not). To this day, a RCT has never been conducted on bracing or surgery.

Interesting sidenote: one of the only published RCT's to even involve scoliosis patients was published by Leatherman & Dickson in 1979, and showed that just eight days of exercises can improve the flexibility of the spine in scoliotic patients, converting a rigid, structural scoliosis, into a mobile, functional scoliosis - very encouraging news for alternative methods of treatment! I often wonder why, in the face of such powerful evidence, patients are not told to perform spinal mobilization exercises pre-surgery to improve the flexibility of the spine and hence the degree of obtainable correction, but I digress...
Obviously, a RCT suffers from the strictest limitations, one of which could be considered ethical in nature. Patients do not have a right to choose if they would like to receive treatment or not; if you would be reluctant to waive your right to choose your own treatment option for yourself (or your child), then you can understand why many patients are reluctant to participate in a RCT. In addition, those patients who were selected to be in the control group may experience deterioration of their condition while they are receiving sham treatment (and, due to the blinded nature of a RCT, they may be deliberately, albeit voluntarily, misled into believing that they are receiving effective treatment for their condition). Or, you may find yourself receiving treatment which is not delivering optimal results; should you elect to switch treatments or drop out, your participation in the study will be invalidated.

In consideration of the limited resources at our disposal, and the ethical considerations of designing a RCT, our agenda is to publish as many Case Reports of the individuals who have undergone treatment as possible; then, using this data then as evidence to help us achieve grant funding, we will be able to pursue prospective multicenter cohort studies. If you've never published a research article, please believe me when I say that it's a far more challenging endeavor than one might suspect! It's not as simple as just writing data down and sending it in to a journal, and it can be quite costly - even more so if the researcher gets paid. Right now the best we have to offer is Case Reports. We readily recognize the limitations of this tier of research, and cede the point to those who would desire a higher level of evidence immediately – so would we. Unfortunately, until such time as when bracing & surgery can stand up to the rigors of a RCT and validate their efficacy, there is no need to subject patients to the uncertainties of mere observation, the psychological trauma of bracing, or the physical scars of surgery; currently, we put forward data that is of no less significance that what other treatment options have provided to date.


One of the goals I am currently pursuing is the establishment of an online network that would allow CLEAR doctors to upload the case histories & x-rays of their patients (minus all confidential information, of course). In addition to providing us with the data we need to publish multicenter research studies, this would also empower CLEAR Institute to further refine its techniques.

You see, the techniques that CLEAR Institute is using to treat scoliosis are continually changing. One of my favorite sayings is, "We always reserve the right to get smarter." Unlike bracing & surgery, whose basic principles underlying the goal of their treatment have not changed since their inception, CLEAR's method has an entirely different focus. Traditional medical science views the spine as a bridge connecting the head and the hips; if a bridge starts to buckle, the correct thing to do is fuse it or brace it. However, chiropractic science views the spine as an engine, one that requires motion and feedback from its environment to function. If you have a six-cylinder engine that is not running correctly, and you fuse three cylinders, would you expect it to run better or worse? Similarly, there are mechanoreceptors in the spine that participate in a motor-sensory feedback loop with the brain and the body's other righting reflexes, such as the ears & eyes - much like the temperature, oxygen, & fuel sensors in your car help your engine to run optimally. An impairment of this loop could influence the development or progression of scoliosis, so one of the goals of our treatment focuses around re-training the patterns that the body uses to orient itself in time & space (proprioception). Bracing & surgery, as passive therapies, do not influence the active & re-active neurological systems of the body.

The point I am making with this is that what bracing & surgery are trying to do is very simple & straightforward, and they've been trying this same approach for centuries. CLEAR is trying an entirely new approach, one that no one else has done before, and to be honest, we readily admit that we don't have it all figured out yet; neither does anyone else! If there were any scoliosis experts, there would be no scoliosis. We don't yet know what therapies are the most beneficial, or which ones could be left out of the treatment plan without adversely affecting the patient. We have made, and continue to make, a great deal of progress in refining our approach - using new digital motion x-ray technology, we were able to determine exactly which exercises were most effective, eliminate some that were less than ideal, and combine others to help our patients save time. Today, a CLEAR patient performs exercises that take up one-third of the time that they use to, yet on average experiences better results. The same goes for our equipment, our adjustments, and every other modality - the more we learn & refine, the better results we achieve. We don't want to rush it and publish results using unrefined protocols that present our methods as less effective than they truly are today. Writing research takes time - the study you publish today is always on yesterday's results. In our first study, three patients out of 22 dropped out; in the second, seven out of 140. It's reasonable to conjecture that, had we used the minimized exercise approach we are utilizing today, some of these patients might have continued with care, and thus influenced the results of the research. The same goes for the reduction in the Cobb Angle - we know that we can achieve a much better correction in a much shorter amount of time than we once could. But why do some corrections hold, why do some worsen, and why do some continue to improve? Obviously patient compliance & follow-up is a large part, but what else influences the permanence of the results? We're still trying to understand.

Working with scoliosis is a very challenging endeavor; one that exposes you to a great deal of criticism from individuals who are comfortable with the status quo, many of whom personally contribute very little in terms of actual progress, prefering instead the easy moral lassitude of taking shots at those who dare to try. I wouldn't be in this field unless I believed with all my heart that scoliosis patient deserve more options, not less, and that CLEAR's method is viable, scientific, and will withstand the test of time in comparison with the barbarism of fusing spines to treat one symptom of a condition while we readily admit our ignorance in knowing its cause. Lacking knowledge of a cause, all treatment must by nature be incomplete, aimed only at relieving the associated signs & symptoms of a deformity which continues to be driven by the cause, which we are blind to in our ignorance. CLEAR's treatment is based upon the premises that Dr. Clayton Stitzel outlined perfectly in an earlier post (Cause of Scoliosis, Initiating and Progressive Factors, posted on 5-18). We believe these to be the causes of scoliosis, and through our treatment we aim to treat the cause, because in doing so, the associated signs & symptoms will improve concurrently. This just makes more sense to me than fusing an engine together because we don't understand why it's functioning differently.

Returning to the original question, as I mentioned earlier, the triangle of Evidence-Based Medicine consists of three key points: the best available research, the clinical experience of the doctor, and the personal needs of the patient. It's important to note that research is only one factor; if a patient adamantly refuses to undergo surgery, all the evidence in the world in favor of surgery is irrelevant.

One of the little idiosyncrasies I have noted in the world of researchers is that many of us like to pretend we exist in a separate bubble, and that only published findings matter; if you can't prove it through research, it might as well not exist. This attitude is often exemplified by the "Parachute Study" - if you haven't heard of it, it can be acccessed here: http://www.bmj.com/cgi/content/abstract/327/7429/1459.

In short, I encourage you to make the best possible decision with all of the information you have on hand; just as you shouldn't make a decision based upon one testimonial, don't let research be your only deciding factor as well. Research is an inductive science - analyzing a small piece of the puzzle and trying to figure out how it fits into the big picture - and it doesn't always apply well to the real world, or to the realm of clinical science, where meeting the needs of the patient is paramount, as opposed to research, where the gold standard of a RCT by its very nature considers the needs of the patient irrelevant.

As always, feel free to e-mail me privately or respond to this post if there is ever any additional information I may provide. It is wonderful to know that individuals such as yourselves are interested in delving deeper into the science behind various systems of scoliosis treatment, and I consider it a privilege to provide assistance.