An FDA first for chiropractic

The Food & Drug Administration (FDA) has granted a 510K medical device designation to an instrument whose sole purpose is designed to correct the vertebral subluxation. FDA 510K clearance allows for the legal sale of an instrument and its particular indication of use. The Integrator is chiropractic's first adjusting instrument to receive an FDA 510K that has gone through a funded, independent randomized, clinical trial.

Designed by Dr. Jay M. Holder, the Integrator is manufactured by Moyco/Union Broach, one of the oldest and largest surgical instrument manufacturers in North America.

According to Lonnie Graybill, vice president of Moyco: "Unlike some of the other adjusting instruments found on the market, we have followed federal regulations; protecting ourselves and the chiropractors that use the Integrator, we're in compliance."

Not only is the Integrator's FDA clearance exceptional, but more so is its history.

Originally created from scratch, borrowing nothing from any current adjusting instrument, the Integrator was designed to reproduce what the hands of a chiropractor were intended to deliver: recoil, torque and dynamic thrust. No other instrument in chiropractic has ever had that in mind.

The Integrator would never have been invented at all, but for the demands required to conduct a human population research study designed by Robert Duncan, Ph.D., of the University of Miami School of Medicine and funded in part by the Florida Chiropractic Society. A totally new chiropractic adjusting instrument (the Integrator) and a technique (Torque Release Technique) were born out of this study by accident and without intention.

The purpose of the study - a 1-1/2 year-long randomized clinical trial with 98 human subjects, blinded and with placebo control - was conducted to determine the outcomes that subluxation-based chiropractic had in affecting state of well being (quality of life) in the human population.

The project, conceived by Dr. Holder, was performed at Exodus, a residential addiction treatment facility in Miami. According to Holder, medical director/founder of Exodus, the addicted population best serves as a proving ground for chiropractic for several reasons:

Chemicals are one of the major causes of subluxations. Twenty- percent of the American population suffer from addiction. Up to 83% of all crime is drug-related. The nation's leading cause of death is drug-related. And the addicted population is identified as suffering from RDS (Reward Deficiency Syndrome), an inability to express a normal state of well being or maintain a quality of life equal to the rest of the general population.

Says Holder, "The last thing chiropractic needs is another neck or low back study. Today chiropractic needs studies on human potential, state of well being and quality of life."

However, in designing this study, a major hurdle had to be overcome: consistency and reproducibility in the application of delivering the chiropractic adjustment and some way to measure its outcome.

To accomplish this, it was necessary to adjust by instrument. Yet, all chiropractic adjusting instruments tested were not reproducible when applied to the patient. A major flaw in the studies and claims attesting to the reproducibility of adjusting instruments is that they test their instruments while clamped in devices that fire the instrument against a measurement device (piezo-electric transducers). Any instrument tested in this fashion is claimed reproducible.

Unfortunately, instruments held by hand against the skin of the patient and fired by hand, are not reproducible, concludes Holder. If the pressure against the tip of any adjusting instrument varies as much as 1/8 of an ounce, the dynamic forces, frequency (Hz), and kinetic energy characteristics will vary as much as three-hundred percent!

To guarantee reproducibility, the development of an automatic trip sensor mechanism had to be made. This would assure that the instrument would fire when an exact predetermined pressure was reached when placed against the skin of the patient and at specific line of drive desired.

Further, this guarantees that a correct and specific frequency (Hertz) is delivered and now allows for a more stable line of drive, often sabotaged in instruments that must be squeezed to fire. Since the purpose of the study was to determine the outcome of traditional chiropractic, an instrument had to be developed that delivered what the hands were intended to.

Up to now, all adjusting instruments provided only axial force. However, the hands provide, at the option of the chiropractor, two more dimensions: recoil and torque (right or left), as in the most traditional application of the chiropractic adjustment, toggle recoil. Torque allows for a line of drive that remains more stable with deeper penetration and recoil allows for greater thrust outcome with less force.

"Less is more," according to Holder. B.J. Palmer demonstrated a nail being hammered into a wood beam. The nail was driven into the wood after the hammer left the head of the nail, not when it was struck (recoil). Speed is also a factor, in that force = mass X acceleration. The Integrator fires at 1/10,000th of a second, making it the fastest hand held adjusting instrument.

Unlike other instruments, that use metal caps and weights to mediate or compensate for their inability to allow the doctor to adjust force, the Integrator has true force adjustment capability.

In a rare interview for Drs. Patrick Gentempo and Christopher Kent's "On Purpose" subscription tape service, Holder discussed the objective outcome measurements of this study that clearly validated the effectiveness of both the Integrator and Torque Release Technique.

These results assessed by Dr. Duncan revealed a retention rate of 100%, a significant reduction in nursing station visits, an improvement in depression that four weeks of chiropractic surpassed what normally takes one year to achieve with standard medical model treatment, and an improvement in anxiety that four weeks of chiropractic surpassed what normally takes six months to achieve with the standard medical model.

TRT is a non-linear vitalistic model and is the first technique in chiropractic to be born out of randomized clinical trial research first, instead of the other way around. TRT training takes one weekend (14 hrs.) and doesn't require the use of an instrument.

Dr. Frank Sovinsky, founder of Chiropractic Mentoring Experience states, "The Integrator is a remarkable innovation in a hand held instrument. TRT has opened up a whole new window in which to view the tonal model of the vertebral subluxation complex." Whether or not we wish to accept Torque Release Technique and the Integrator, the research is in.

For more information or to receive a complimentary copy of the "On Purpose" audio tape, contact the Holder Research Institute at: 800-490-7714 or 305-535-8803.

New Technique Introduces… EEG Confirms Results

One of the most exciting events during Life College's 20th anniversary Homecoming was the debut of the Torque Release Technique™, billed as the first and newest adjustment technique for chiropractic's second century. The debut was no less exciting for having been unplanned.

Jay Holder, DC, MD, PhD, winner of the Albert Schweitzer prize in medicine and chairman of the World Chiropractic Alliance Addictionology Committee, was presenting 12 hours of training in chiropractic addictionology and compulsive disorders at Life's Marietta campus when he began to discuss his latest research on what he states is chiropractic's first true scientific model of subluxation-based chiropractic, "The Brain Reward Cascade Theory."

Although it was not his intention, Dr. Holder found himself not only unveiling a new technique and adjustment instrument but within an hour was having it put to the test.

Lasca Hospers, DC, PhD, a renowned neuroscientist in EEG, was intrigued by the concept and application of a new technique that integrated the new scientific principles of quantum physics, right brain processing (mind/body) and the original principles of chiropractic.

Yet, her initial reaction was that Holder's Brain Reward Cascade Model - a neurophysiological explanation of the subluxation vs. state of well being - might not hold up under practical application or pre- and post-scientific scrutiny.

In an auditorium packed to capacity, Dr. Hospers stood up and challenged Holder to an on-the-spot-test. "I'll bring in our equipment and run an EEG, then have you adjust the patient with your new instrument and technique and then run another EEG to compare the difference, "said Hospers, who is a prominent expert in the brain mapping of patients suffering from Attention Deficit Hyperactivity Disorders (ADHD).

For the challenge, Hospers chose a person known to have ADHD. ADHD afflicts four million children in the U.S. and a larger number of adults. A compulsive disorder caused by a gene defect, ADHD is considered the most common pediatric disorder.

Hospers knew that the person she chose would have abnormal prefrontal spiking on EEG and the pre-adjustment strip confirmed that prediction, which is typical in ADHD patients.

Holder then checked the patient by using the Torque Release Technique methodology and adjusted with a new hand-held instrument prototype called the Integrator™. Holder noted that "This instrument delivers a third dimensional force, Torque, that no other adjusting instrument in chiropractic does."

After the patient was adjusted, a post EEG was run and examined. Hospers explained her findings: "All of the abnormal prefrontal spiking found earlier was gone and that the entire EEG was now essentially normal."

As the program continued, Holder explained that both the Integrator and the Torque Release Technique were originally developed for the purpose of conducting a human population research study on the effects of subluxation-based chiropractic and drug-addicted individuals in a residential addiction hospital setting.

Designed by Robert Duncan, PhD, at the University of Miami School of Medicine and the Holder Research Institute, and supported in part by a grant from the Florida Chiropractic Society, this randomized clinical trial (blinded and with placebo control) represents the largest human population study in the history of chiropractic.

"We had to invent a totally reproducible chiropractic adjustment instrument that delivered what the hands did and make it inter-professionally reproducible as well, or we would not have satisfied the University's department of biostatistics research design standards," said Holder.

The findings of the 18-month study are scheduled for publication early this year.

This next-generation technique recognizes that the nervous system has unique memory in its ability to learn, grow it adapts to or recovers from. Therefore, it was necessary to provide a method of analysis and adjusting technique that has non-linear, time sequence priorities - a neurologically based analysis rather than a mechanically based one.

Most importantly, you may integrate current techniques that you may still want to use into this larger application model."

Seminars to teach, demonstrate and experience this new analysis and adjusting instrument will be offered.

For more information contact the Holder Research Institute at 1-800-490-7714 or 1-305-535-8803.