Post Info TOPIC: Reasoning behind choice of chiropractic instrumentation for RCS study

Reasoning behind choice of chiropractic instrumentation for RCS study

While JC Smith offers Gentempo as witness against Dr Rondberg, we find that Gentempo's credibility has plum little to be taken seriously:

Reasoning behind choice of chiropractic instrumentation for RCS study


When we started RCS, the mission was to conduct a large-scale outcomes study to evaluate the effect of chiropractic on vertebral subluxation. The strategy was to recruit and train as many data-collection sites as possible, and to obtain a large sample of patients under study using a variety of subjective and objective outcome measures.


The first objectives were 1) to establish an approved IRB research protocol, 2) to create a data collection network, 3) to recruit and train a cohort of chiropractors to serve as data collection sites, and 4) to create an on-line process for administering one of the major subjective outcome measures, namely quality of life surveys. These objectives were completed within the first 12-18 months of operation.


The next phase of development was to incorporate objective outcome measures, and for this we had a number of possible instrument options and vendors to evaluate and eventually choose from. In the absence of any "Gold Standard" for subluxation detection in the profession (that is, a single instrument that provided a valid indicator for the presence of subluxation) we felt it important to evaluate multiple outcome measures that were being used in the participating offices, and monitor these from the same patient over time. With a large patient pool, this allowed us to validate one outcome measure relative to another using multivariate statistics, and to do this over time in a classic cohort study, time series.


In particular, we knew that many offices were using surface EMG and often other nested equipment for thermography, algometry, heart rate variability, etc. The scientific literature on surface EMG is promising but controversial. Several large insurance companies (Aetna, Blue Cross) had ruled that surface EMG is of insufficient reliability and validity for use as a diagnostic test for evaluating low back pain or other thoracolumbar segmental abnormalities such as soft tissue injury, intervertebral disc disease, nerve root irritation and scoliosis. Thus, in our longitudinal study we sought to increase the validity of surface EMG (and related measures) using our large cohort research design.


To fulfill the research mission of RCS, and acquire the much needed instrumentation data from the patients under study with our IRB protocol, you approached Dr. Patrick Gentempo, President of CLA to facilitate the data transfer. We found that many of the doctors in the RCS study had the CLA subluxation station data on the patient, but it was not in the format that we could use because we needed access to the raw data files.


In spite of repeated efforts, Dr. Gentempo refused to respond to your requests for assistance and cooperation to obtain a simple patch that would have allowed valuable data from the subluxation station on patients in our study to be acquired and analyzed.


At this point, we looked more closely at the systems requirements (filter characteristics, normative database, etc.) and determined that there were other suppliers of surface EMG equipment that would better meet our specifications. The one we settled on was Thought Technologies, a company that has been in business for many years manufacturing largely biofeedback devices and other electronics used for medical and diagnostic purposes. The Thought Technology equipment is exclusively marketed to chiropractors through another company, NeuroInfiniti, owned and operated by Dr. Richard Barwell. The discussions with Dr. Barwell and the President of Thought Technologies, Dr. Hal Myers, were successful and RCS began the process of integrating the data stream from the NeuroInfiniti equipment into the RCS data collection network.


It is important to distinguish the type of surface EMG signals that we proposed to collect and analyze with the RCS research protocol. The controversy I mentioned earlier about surface EMG applies largely to static, paraspinal EMG. On the other hand, the NeuroInfiniti equipment utilizes another type of protocol with bilateral surface electrodes, namely dynamic EMG. Dynamic EMG offers many advantages over static EMG employed by CLA, and should provide us with accurate and reliable changes in dynamic muscle tone before and after the chiropractic adjustment, and over time while the patient is under care. Practitioner training on the use of dynamic EMG is critical for obtaining reliable data, which is another reason we went with NeuroInfiniti (see also below).


Moreover, the NeuroInfiniti device comes with a host of other devices to measure brain function (EEG), stress and autonomic outflow (thermography, heart rate variability, respiratory effort). Dynamic EMG and each of these other independent (and objective) measures will provide an assessment of the patient that can be correlated statistically with the quality of life measures to address the overall hypothesis, including the neurological basis of the subluxation, being tested with the RCS protocol.


To be honest, I found the uncooperative attitude of CLA officials to be totally unacceptable. With the NeuroInfiniti equipment manufactured by Thought Technology, it is my belief that we have a more reliable series of instruments that can be readily adapted to our purpose of integrating with the RCS data collection process. Moreover, NeuroInfiniti has taken great pains to train all there investigators which will also add to the reliability of the data to be obtained.


Bob Blanks



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