CBP^® Protocol of Care

Since the Mercy Center Guidelines of the early 1990’s, claims have been cut before or near 12 visits per patient. Even though these guidelines were mainly for low back pain, IMEs have continued to use these guidelines inappropriately by applying these guidelines to multiple other health and spinal conditions. This has caused many DCs to implement cash practice programs to minimize interference by 3rd party payers with care recommendations.

Recent Developments

USA State Boards and Canadian Provincial Boards are beginning to bring DCs up on charges of over utilization for extended care programs and for the use of x-ray as a diagnostic tool for evaluating presence and amount of subluxation. These ACA proposed and directed local guidelines are often contrary to existing State or Provincial practice laws or are merely Board rulings. Because Health Care Boards have powers above what the Constitution intended, one must often go through a humiliating Board hearing before being able to appeal any Board decisions to the Court system.

What About 1 Year Prepay Programs

In some instances, States have ruled that prepay programs are essentially the same as the provider acting as an insurance company. As Boards begin to evaluate DCs on an “Evidence Based” concept, they are applying literature used in the Mercy Center Guidelines and similar recent published papers to “prove” that a certain number of visits for a certain condition is beyond the “Standard”. At this time in January 2002, there are no published trials supporting 6 month programs of care or 1-year programs of care. This creates a very difficult situation for any DC going before his/her Board for utilizing long term care programs.

CBP® Solution

We have in our long-range research plans to evaluate postural and spinal corrections/stabilizations in long-term care programs of a year or more compared to shorter-term programs. However, research is terribly time/dollar consuming and many smaller studies are needed before advancing to Randomized Clinical Control Trials (RCTs) of long-term programs of chiropractic methods. At present, CBP® has completed 6 Non-randomized Clinical Control Trials that can be used to support long-term programs in individual cases. Persons not familiar with a hierarchy of evidence in research should at least realize the level of proof in the following types (listed lowest to highest evidence):

1. Case Study
2. Case Series
3. Case Control Series
4. Cohort Studies (there are several types)
5. Non-Randomized Control Trial
6. Randomized Control Trial

From this list, one realizes that the 6 presently completed CBP® Non-randomized Control Trials are the 2nd highest type of evidence.

Five CBP® Case studies are in press at JMPT, while the six CBP® Clinical Control Trials are published/accepted/in review at JMPT (2), Archives of Physical Medicine and Rehabilitation (2), the (USA Veterans Administration journal) Journal of Rehabilitation Research and Development, and the European Spine Journal. By anyone ignoring this evidence for long-term care, it can only be considered as a deliberate bias against CBP® in particular and long-term structural care in general.

The CBP® normal spinal model is used as a goal of care, along with pain, function, and quality of life measures. The CBP® normal spinal model areas have been published in various prestigious Index Medicus orthopedic journals (Spine, Journal of Orthopedic Research, and the Journal of Spinal Disorders).A-F We list these as “evidence”:

These CBP® spinal models are of two types: ideals and averages. The average models have normal values for segmental and global measurements, are based on real live subjects, and have predictive validity (are able to discriminate between pain groups and normal subjects). There has been some backhanded criticism of these studies by persons stating that the Harrisons are too close to their own work, i.e., we must have cheated some how on the data to get in such prestigious journals. This attitude towards CBP® research is an insult to the whole CBP® Research Team, which, besides the Harrisons, includes Rene Cailliet, MD (world’s most renown physiatrist), Burt Holland, PhD (Professor of Statistics at Temple Univ.), Tony S. Keller, PhD (Professor of Mechanical Engineering at Univ. Vermont), Bill Jones, PhD (Professor of Mechanical Engineering at Mississippi State Univ.), Tad Janik, PhD (Research Scientist for a Defense Contractor and former Professor at Univ. Alabama in Huntsville), and Stacy F. Harmon, DC, MD (Emergency Medicine, Marion Medical Center in California).

We will use the reported average results of the 6 CBP® Clinical Control Trials as estimates of the need for long-term care.

Table 1

Average Data From 4 CBP® Sagittal View Non-randomized Clinical Control Trials

Table 2

Average Data From a CBP® AP View Non-randomized Clinical Control Trials

Estimating Need for Care

Using Table 1, we may hypothesize what it might take to get a typical/average patient to near normal in his/her cervical or lumbar lordosis. For example, if a patient’s initial lumbar curve ARA was -18°, then two average programs of CBP® lumbar traction of 38 visits in 3 months, = 76 visits in 6 months, would hypothetically result in two increments of the average improvement of –11.3°, or 2 x (-11.3°) = -22.6° + -18° = -40.6°, which is near the ideal normal lumbar ARA value of -40°. Table 3 gives some average data values applied to multiples of the 5 CBP® published/in review programs. Also Table 3 gives average data for what it might take to reduce trunk list on the AP lumbar view as measured by horizontal displacement of T12 compared to a vertical line up from S2 tubercle.

Table 3

Hypothetical Programs extrapolated from Data from 6 CBP® Control Trials

Are Posture and X-ray positioning Repeatable?

It is often claimed by IMEs for different insurance companies that posture and x-ray positioning are not repeatable. These IMEs claim that posture and x-ray displacements cannot be used for clinical outcomes. This is in opposition to the Index Medicus literature.

Can 1 Year Programs be Extrapolated From This Data?

Yes, one could add/augment 4 visits/month for one month, 2 visits per month for 2 months, and/or 1 visit per month for the remaining months to total 6 additional months (to arrive at a 1 Year program).

What If the Patient Has More or Less Initial ARA Compared to Values in Table 3?

a) If the patient’s curve ARA measurement is below (in absolute value) the average initial ARA in Tables 1 and 2, then it would be possible to extrapolate the need for 3 programs of 3 months each. For example, if the patient had a kyphotic cervical curve ARA measuring +2°, then 3 programs of 3 months each of CBP® 2-way traction might be needed on average, i.e., +2° + 3(-14.2°) = -40.6°, which is near to the normal of –43°. b) If the patient’s curve ARA measurement is above (in absolute value) the average initial ARA in Tables 1 and 3, then one would be hard pressed to show the need for 2 programs of 3 months each. For example, if the patient had a cervical ARA = -29°, then only one program of 3 months of CBP® 2-way traction would hypothetically get him/her to –43°, i.e., -29° + average improvement of -14.2° in 3 months = -43.2°.

What Technique Must I Practice to Use these Arguments to Support my Care?

Obviously these two Tables are based on CBP® Traction studies. You must be utilizing CBP® Mirror Image® adjusting methods and one of our traction methods to use this data to support your care recommendations.

X-Ray Protocols and Exposure

Our critics have often claimed that (1) x-ray line drawing is not reliable, (2) we are over-utilizing x-ray, and (3) unnecessarily exposing our patients to ionizing radiation. These are all false statements. Firstly, we have conducted and published 10 x-ray line drawing reliability studies. The most recent were in Spine and JMPT.^26-29

These studies not only show high reliability, but our reference sections in each publication indicate that previous studies show high reliability for geometric line drawing on radiographs.

Secondly, in our CBP® Protocol of Care, it is recommended that the Doctor obtain Posture and Radiographic measurements. These measurements are necessary to determine the type of care needed. The frequency suggested for radiography is initial and then follow-up views-measurements at 36 visit intervals. From our 6 published CBP® Clinical Control Trials, the average patients needs 6 months of intensive care to achieve a near normal spinal and postural alignment. This would result in one initial set of x-rays and two follow-up sets. This is a very minimal frequency compared to orthopedic surgeons who often take initial, pre-operative, immediate post-operative, one week, one month, 6 months, and long-term follow-up radiographs for surgery cases. As CBP® protocols are evaluating and monitoring structural spinal changes, so are these orthopedists. Several of the CBP® Research Team (Rene Cailliet, MD, Deed E. Harrison, DC, Donald D. Harrison, PhD, DC, and Tony S. Keller, PhD, &Christopher J. Colloca, DC is being considered in 2004) are members of the International Society for the Study of the Lumbar Spine (ISSLS), of whose members, 2/3 out of 250 world wide, are orthopedic surgeons. These surgeons report at our annual ISSLS meetings that approximately 4-6 radiographs and 1-2 CATSCANs or MRIs are obtained of each patient (before, during, and follow-ups on surgery cases). Their medical radiologists read their films and do not chastise them for obtaining structural information regarding spinal alignment changes.

Lastly, medical x-rays are of very minimal health risks. From Butler [Butler G. Inflight Occupational Exposures to Cosmis Radiation and Magnetic Fields. Air Line Pilot 2000; Jan: 30], one can calculate the routine exposure of airplane passengers and crew. For example, based on 0.60 mSv (= 0.6 x 0.1 rem) per 100 block hours (the mean for a flight between New York City and Athens, Greece), a pilot flying 700 block hours per year would receive an annual occupational exposure of 4.2 mSv (= 0.42 rem). In contrast, a pilot flying 700 block hours on a Chicago-to-San Francisco route (0.41 mSv/100 block hours) would receive an annual dose of approximately 2.8 mSv (= 0.28 rem).

This Chicago-San Francisco dose is 0.28 rem/yr = 280 mrem/yr = 5.4 mrem/wk, while according to Cohen and Lee (Cohen BL, Lee IS. A Catalog of risks. Health Physics 1979; 36(Jun): 707-722.) “smoking a cigarette has the risk equivalent of 7 mrem of radiation , and an overweight person eating a pie a-la-mode runs a risk equal to that of 35 mrem”.

Equating absorbed dose and dose equivalent, 1 rem = 0.01 J/kg = 1 rad, we can determine the dose equivalent for medical x-rays:

It now becomes obvious why our Federal government and Airplane companies (such as Delta) do not tell pilots to stop flying after one year. If a pilot reduces his desserts, he cancels out his equivalent radiation risks!! The government on its website states that a flight from LA to NY and back is approximately worth one chest x-ray due to being in the upper atmosphere. Thus pilots that fly two round trips from LA to NY per week get 2 chest x-rays per week or about 100 per year!! After 10 years, a Delta pilot has 1,000!!

Continuing with risk from x-ray exposure, claims of over-exposure are complete fabrication and personal opinion, which we do not share. The risks of medical x-ray views are so minimal that it is more hazardous to be overweight or drink a soft dink. These facts were put in perspective recently by the late Edward Maurer, DC, DACBR. We reprint his article from Dynamic Chiropractic (http://www.chiroweb.com/archives/08/14/11.html) for the reader’s education.

“Risk Perspective”

by Edward L. Maurer, D.C., D.A.C.B.R.
Kalamazoo, Michigan

Environmental pollution, cholesterol, steroids, drugs, iatrogenic disease, radiation effects, and others, have all been highly visible in the media over the past few years. Near daily announcements are made of items which are purported to be carcinogenic. One begins to wonder if it would be easier to list the things that do not cause cancer.

Radiation health and safety are being discussed at social gatherings, and people are generally more aware of associated risks. Many still have visions of Nagasaki, Hiroshima, Chernobyl, and Three Mile Island whenever radiation is mentioned. Little wonder then that patients frequently ask questions related to the necessity and safety of radiographic procedures. At times simple reassurance will suffice, but often we must attempt to help put things in perspective.

Science and technology have combined to provide some of the most in-depth studies of ionizing radiation known to man. The International Atomic Energy Agency (IAEA) states that “radiation and its effects have been studied by expert bodies for over half a century and more is known today about radiation risks than about those of practically any other physical or chemical agent in our environment.”

Authorities agree that while no radiation dose level is risk-free, the level used in diagnostic radiology provides low-dose risk and is considered as acceptable to the average individual. According to the 1949 National Council on Radiation Protection and Measurements (NCRP), the definition of permissible dose is: “Permissible dose may then be defined as the dose of ionizing radiation that, in light of present knowledge, is not expected to cause appreciable bodily injury to a person at any time during his lifetime.” Since this NCRP statement, the trend in science has been away from the “permissible or acceptable” dose concept to the current “risk” concept. In either approach, the end result is similar, e.g., for the information gained with diagnostic radiology, the radiation risk is minimal.

The IAEA states that “one should not disregard the risks posed by radiation as a health hazard, but it does not pose a unique set of health affects.” Other agents pose a much greater health risk. “It is about 100 times more likely that cancer will be produced in the average individual by some other cause than by radiation.”

An interesting article by Cohen and Lee entitled, “A Catalog of Risks,” published in Health Physics, provides a look at radiation risk levels, along with other examples of risks associated with various activities and how they translate into loss of life expectancy. It provides the likely results of both general patterns of behavior and one-time occurrences. According to the study: The drinking of one diet soft drink per day reduces life expectancy by two days; ingesting 100 calories per day by drinking regular soft drinks increases body weight by 7 pounds and reduces life expectancy by 210 days. If you are 30 percent overweight you lose 1,300 days; 20 percent overweight 900 days. Unmarried males lose 3,500 days, smokers 2,250.

While accidents in an average job cause 74 days of life loss, a job with radiation exposure carries only a 40 day loss. An average person who receives a lifetime of medical (diagnostic) x-rays, results in a life expectancy loss of six days. Radiation to workers in the nuclear industry lose 0.02 days. Single, individual acts and their associated risks were also reviewed. Smoking one cigarette reduces life expectancy by 10 minutes, eating a calorie-rich dessert by 50 minutes; and the missing of an annual PAP test will cost the average woman 6,000 minutes. One millirem of radiation reduces life expectancy by 1.5 minutes.

This study and many others point out that risks are associated with nearly all activities of daily living. Some can be guarded against, for example, wearing a seat belt, losing weight, stopping smoking, etc., but even these measures will not eliminate all risk. Minimal risk in everything we do during the human experience is near-inherent. While we must constantly work towards the reduction of risk, in all endeavors, we must accept a minimal level as normal. Diagnostic radiology does present risk; but the radiation dose when compared to the benefits of useful information gained, necessary for appropriate treatment selection, is indeed an acceptable trade-off when put into perspective.

In summary, logic must prevail and the use of radiography in chiropractic given the respect that is deserved. Clinical x-rays are of minimal exposure (health risk) and provide the necessary information for doctors interested in structural outcomes.

When Does CBP® Suggest Starting Exercises and Traction?

In our studies in Table 1 & 2, the programs were 3-5 times per week. We recommend separating acute care from corrective/rehabilitative care. The Mercy Center Guidelines, which we think are the worst guidelines ever suggested, allow for daily care for the first three weeks for acute pain. Thus, we suggest that you see the typical patient daily for three weeks and then 3-5 times per week for an additional 9 weeks. Re-examine, both posture, orthopedic/neurological and x-ray at 3 months (12 weeks). Since all our Clinical Control Trials averaged approximately 36 visits, one may substitute 4 visits per week for 9 weeks (36 visits) or 3 visits per week for 12 weeks (36 visits) in the suggested schedule below. Note that exercises and traction will start after 3 weeks of acute care. We have written a suggested schedule below:

I. Minimum Care Program

The care program is 6 months, i.e. from Table 3, the average patient has need of two 3 month programs. If only one 3 month program is needed because the patient has only slight loss of lordosis, and then another 3 months of 2 visits per month can be augmented to arrive at 6 months. This basic “3 month program” could be modified from 3 visits per week for 12 weeks = 36 visits to 4 visits per week for 9 weeks = 36 visits.

II. Two types of care:

A. Relief Care or “Patch Care”, First Three weeks of care
    1. Goals are reduced symptoms & increased range of motion
    2. Diversified- Manipulation
    3. Soft Tissue work (NIMMO)
    4. Ice
    5. Stretching

B. Corrective/Rehabilitative Care
    1. Beginning of 4th week through end of 12th week
    2. Goals are Posture and sagittal curve improvement
    3. Mirror Image Drop table
        a) AP set-up (full spine)
        b) Lateral set-up (full spine)
        c) Pelvis to feet set-up
    4. Cervical instrument full spine set-up
    5. Cervical extension-posterior translation traction
    6. Lumbar Extension-translation traction
    7. Mirror Image exercises

C. In first 3 month block, mini-Exams and mini-Reports given every four week units of care
    1. Report of Findings (ROF) is 5 minutes
        a) Choice of RELIEF vs. CORRECTION
        b) Use of X-ray RED lines (normals) & BLACK lines (centers of mass)
        c) Cover four basic patient concerns
            i)  Did you find my problem?
            ii) Can you fix ME?
            iii) How long will it take?
            iv) How much will it cost?
        d) Give patient ICE and YOGA stretching sheet
    2. Fourth (4th) Week Mini-Exam and Mini-Report
        a) Posture, Ortho, Neuro, Outcome measures
        b) No x-rays
        c) Report covers exam improvement & show old x-rays to emphasize
        d) Give Patient Exercises
            i)  1 full Spine AP Exercise with 1 major skull, one thorax, one pelvis
            ii) 1 full spine lateral Exercise with one major skull, thorax, and pelvis
    3. Change method of care from RELIEF to CORRECTION, i.e. no more manipulation, ice, trigger
        point, Now Drop Table, Traction, Cervical instrument
    4. Continue Mirror Image TRACTION IN OFFICE FOR NEXT

D. Eighth (8th) Week Exam and Report
    1. Emphasize POSTURAL IMPROVEMENT with postural exam, Ortho, Neuro, Outcome measures
        (No x-rays at this 8th week exam)
    2. Report re-emphasizes old x-rays & postural improvements
    3. Give Patient HOME TRACTION DEVICE AND EXPLANATION SHEET

E. Twelve (12) Week Exam and Report
    1. X-rays major part (Posture, Ortho, Neuro, should be vastly improved)
    2. Report deals with percentage of x-ray improvement
        a) AP x-ray: BLACK line (centers of mass) should have corrected with postural correction
        b) Lateral curvature % correction indicates need for further care
        c) Recommend continuing another 12 week care plan unless correction is greater that
            expected.

III. Repeat Multiples/Blocks of CBP® 3 month Programs as needed for correction

    1. Visits are 3-5 times per week for 12 weeks for each block of 3 months as indicated by Table 2
    2. Doctor may need to alter traction method or weight or time as indicated by post x-ray measurements.
    3. Examinations and Post X-rays are obtained every 12 weeks
    4. Reports are given after every 12-week block of care