Date: Friday, December 8, 2000 11:28:39 AM From: Christopher J. Colloca, D.C. Re: Activator Lawsuit in Saskatchewan, Canada From: Christopher J. Colloca, D.C. Re: Activator Lawsuit in Saskatchewan, Canada Dear Doctor: In the early 1990¼s, a bylaw was passed in the province of Saskatchewan, Canada by the Chiropractic Association of Saskatchewan (CAS) that prohibited the use of the Activator Adjusting Instrument in place of Manual chiropractic adjustment in the province. At that time, the members voted that they believed that there was not sufficient scientific evidence to justify the use of the Activator Instrument as a primary form of chiropractic adjustment. It was reported that leaders of the CAS also believed that the instrument¼s thrust did not constitute a chiropractic adjustment in their opinion. Further, a general view was held by those in favor of the bylaw that chiropractic adjustment required joint cavitation for successful intervention. Chiropractors in the membership pleaded with their association to allow them to use their chiropractic technique of choice. They reiterated that there are numerous adjustment techniques used by chiropractors, many of which do not achieve audible joint cavitation (Thompson-Drop, Toggle, Flexion-Distraction, to name afew). The president of the CAS at the time, requested published research and other information on the Activator Method and after reviewing it prepared a report that was presented to the membership. This report only reinforced the views held by the CAS leadership that Activator should continue to be banned as an alternative type of chiropractic adjustment. The CAS president noted that they would continue to review new research on Activator and were open to consider new information as itappeared. In the years that followed, Saskatchewan chiropractors were called before the CAS and fined for using the Activator Adjusting Instrument ontheir patients. One Chiropractor in particular, Dr. Brian Thompson, has been fined by the CAS approximately $20,000over the years for practicing the method that he feels is best for his patients. From court battles in the 1990¼s, Dr. Thompson has personally paid about $60,000 in legal fees whileattempting to defend his rights to practice his technique of choice, Activator. The situation escalated in the late 1990¼s when Dr. Thompson and other chiropractors were again called before the CAS for issues again involving the use Activator on their patients. Fourteen chiropractors, including Dr. Thompson, decided to file alawsuit against the CAS to try and stop the ban on Activator. Noteworthy is the fact that many of these doctors weren¼t even Activator practitioners, but believed that chiropractic¼s scope should not be limited to Diversified only! This courageous group divided up the legal fees, amounting to $12,000 each, and took their case to trial. In February, 1999, I was called as an expert witness on the Activator Method. At that time, I was the Vice President of Activator Methods, Inc. and took time out of my practice to fly to Saskatoon, Saskatchewan to testify before the Queen¼s Court. I prepared diligently for the case and tookwith me copies of every study that I could find on chiropractic technique. It wasn¼t until I arrived, that I actually witnessed what was going on in Saskatchewan. I met at the attorney¼s office for a debriefing and met with several of the chiropractors involved in the suit. I was taken back by the courage and integrity of the doctors who were fighting for their right to practice chiropractic the way that they felt appropriate. It was a moving experience. After staying up until 3:30 a.m. preparing, the next day, I arrived at the courthouse early, having to walk through reporters on my way in with „no comment.¾ After sitting down in court, the opposition saw me. Because I wasn¼t to testify until the next day, the opposing attorney requested I be removed from the courtroom. His motion was granted, and I was forced to leave. This set the tone for the trial. Dr. Thompson testified on that day. When our team convened later that day I asked how his testimony went. Dr.Thompson was asked how many times that he used Activator on his patients. He responded, „I use Activator on all ofthem. Thousands of times.¾ Despite running the risk of being finedagain for such a statement (admitting use of Activator - thousands of counts!), Dr. Thompson had taken a stand! He stood for what he believed and spoke from his heart. He stood with pride for the technique he practiced, despite what others thought. When I learned of this courage, it gave me goosebumps and only strengthened me in my conviction that we were going to win. It reminded me of my college football days preparing for battle ‚ We had a slogan, „Champions Meet Challenges Head On.¾ Brian had stepped up and met the challenge head on - both financially, and in spirit. I couldn¼t wait to testify the next day. My testimony went smoothly. I provided a review of chiropractic techniques, clinical guidelines and research on Activator demonstrating its benefits to the hundreds of thousands of patients receiving this form of chiropractic care. I discussed the benefits of using instruments to adjust the spine, and the philosophy, art, and science of chiropractic. Armed with research, I was able to easily handle cross-examination. For the opposition, two other chiropractors from Saskatchwan testified that there were limitations to the research that I presented, and that they continued to hold the belief, in spite of the new research that I presented, that Activator lacked the evidence in their opinion to be worthy of reversing the bylaw banning its use for chiropractic adjustment. After reviewing all of the evidence, the Judge made his ruling. The Judge found that there was a significant amount of evidence demonstrating the utility of Activator technique, and that it may well be more beneficial to patients as an alternative chiropractic technique of choice. He further found that there was no evidence which fairly supported the proposition that Activator Technique was ineffective. As well, the Judge found that there was a „complete dearth of evidence ¾that would suggest that Activator Technique had any negative attribute or posed any potential threat as a chiropractic adjustment, as opposed to a chiropractic adjustment by hand. We had won! Thebylaw was over tuned, and Saskatchewan chiropractors are able to use Activator Technique on their patients! As you might imagine, the leaders of the CAS were not happy with the Judge¼s decision,and the membership voted to appeal the Judge¼s decision (by a very slim margin!). As a result, the case is being reviewed again before the Queen¼s Appellate Court. The attorneys recently contacted me to review the plaintiffs response to the CAS¼s appeal and to assist in drafting our response. I have done so, and following, you will find a copy of my report. Coincidentally, a case report titled, „Adverse Effects Potentially Associated With The Use Of Mechanical Adjusting Devices (MADs),¾ co-authored by the former president of the CAS appeared in the Journal of the Canadian Chiropractic Association (Nykoliation& Mierau, 2000;43(3):161-167) shortly after the Judge¼s ruling in 2000. This article presented 3 cases managed by doctors utilizing instrument adjusting andmethods that illustrated potentially adverse effects. However, it was later pointed out in the Letters to the Editor that followed that these cases had co-founding variables that well indeed mayhave been responsible for the outcomes. Dr. Thompson has just contributed another $7,000.00 of his own money to hire an expert in administrative law to try and ensure a victory against this appeal. For Dr. Brian Thompson alone ‚ This battle has already cost him over $100,000! At one point, Dr. Thompson had to sell his truck and was walking to the office to see patients. Think about that the next time you are complaining about something! I have volunteered my services for this important legalbattle for chiropractic rights. Be it known that I have no affiliation with Activator Methods International, Ltd.since being fired from my Vice President position in June of this year. Can you imagine if the association succeeded in banning the Activator adjustment? What¼s next, this trickles across Canada and then on to the U.S.? What else in Saskatchewan, banning Drop table, SOT, Toggle, and Flexion-Distraction ‚ all because we don¼t hear the almighty audible? We all need to help protect our rights. Have you ever heard the words, „stand for something, or you will fall for anything?¾ If you would like to help, there is something that you can do. You can send a donation to the legal fund of Thompson et al. v. Chiropractors Association of Saskatchewan. It¼s a worthy cause, and the brave D.C.¼s including Dr. Thompson have given a lot to fight for their right to practice the way they wish. Checks can be made out to Cuelenaere &Co. In the Memo, Write Thompson et al.v. C.A.S. Fund and send to: Cuelenaere & Co. ‚ Mr. Jay Watson Barristers, Solicitors and Mediators #500, 128-4th Avenue South Saskatoon, Saskatchewan S7K 1M8 Blessings to you during this joyous holiday season. We all have a lot to be thankful for. Fond Regards, Chris Colloca, D.C. Phoenix, AZ ************************************************* Christopher J. Colloca, D.C. 11011 S. 48th St., Suite 205 Phoenix, AZ 85044 U.S.A. Tel. 480-785-8448 Fax. 480-893-2412 Email. CJColloca@neuromechanical.com www.neuromechanical.com ************************************************* ************************************************* December 3, 2000 Cuelenaere, Kendall, Katzman, Watson & Hagan Mr. David Smith #500, 128-4th Avenue South Saskatoon, Saskatchewan S7K 1M8 Re: Thompson et al. v. Chiropractors Association of Saskatchewan Dear David: I would like to address the issues that I believe are relevant to the case and do it in a manner in which the testimony on both sides has been given. Summary The Learned Trial Judge correctly ruled that the Activator adjustment constituted a professionally accepted chiropractic adjustment; an adjustment that fairs well as a treatment alternative for certain patient populations and practitioners. Practitioners in the province of Saskatchewan should not be deprived of their right to utilize this widely accepted form of chiropractic adjustment. Supporting Evidence 1. Instruments used to accomplish chiropractic adjustment have been defined as Mechanical Force, Manually-Assisted in the peer- reviewed indexed literature and in professional guidelines. 2. Instruments to adjust the spine are in use by over half of the chiropractic profession in the United States, Canada, and Australia according to published data. 3. The use of the Activator Adjusting Instrument is taught in over 10 accredited chiropractic colleges in the core curriculum or as an elective course including in Canada. It further is taught in chiropractic college sponsored post-graduate educational coursework. 4. The Activator adjustment constitutes a safe alternative adjustment to more forceful adjustments in certain patient populations. 5. By definition, chiropractic adjustment does not require joint cavitation. 6. Basic science biomechanical evidence demonstrates that the Activator thrust creates bone movement. 7. Basicscience physiological evidence demonstrates that the Activator thrust elicits physiological responses in the body. 8. Published research including outcome studies has demonstrated to date that success in patient outcome is no different in patients receiving traditionally applied Specific Contact Thrust (Meric or Diversified) adjustments or Mechanical Force, Manually-Assisted (Activator) adjustments. Discussion 1. Chiropractic Adjustment. As noted in your response to the appeal, despite the opinions of Drs. Nykoliation and Cassidy, chiropractic adjustment, by definition, does not require joint cavitation. You correctly cited my testimony of the Glenerin Conference Guidelines where I quoted the accepted definition published therein. Therefore, any opinions put forth by proponents of joint cavitation, are just that, opinions. I further cited the Mercy Center Chiropractic Guidelines, and U.S. Medicare definitions of chiropractic adjustment. Moreover, I specifically cited a sentence from the Medicare document that clearly states that the Activator adjustment fits the definition of chiropractic adjustment and is reimbursable under the Medicare statute. As you know, chiropractic adjustment can be accomplished through numerous chiropractic techniques. These techniques are taught to the doctor of chiropractic in chiropractic college and in chiropractic college sponsored post-graduate educational courses to be used within his/her best clinical judgement of a particular patient or case. For example, it may not be desirable to use a high force rotary adjustment technique on a patient at risk for cardiovascular disease, disc herniation, osteoporosis, or post-surgical spinal patient (Colloca and Fuhr, 1997;Slosberg, 1994). Based upon the sound clinical judgement of the doctor of chiropractic, alterative chiropractic adjustment techniques are available to adminster to such a patient - be it an Activator Adjusting Instrument adjustment, or a drop table adjustment, or a flexion-distration adjustment - all of which not requiring joint cavitation to successfully accomplish the adjustment. I submitted testimony that the Activator adjustment is taught within the curriculum in numerous chiropractic colleges including Trois Rivieres in Quebec, and that the Activator adjusting instrument has been reported to be in use by over half of doctors of chiropractic (>30,000). In regard to the argument of joint cavitation being arequirement of successful chiropractic adjustment - The Learned Trial Judge was correct in his assessment of the testimony presented that several techniques exist to assist the chiropractor in managing a variety of cases, and also to make available techniques which may be safer on the doctor performing the treatment. If the province of Saskatchewan were to ban the use of the Activator adjustment because it were "not considered an adjustment, efficacious, etc." then the doctors in the province would not be able to utilize techniques taught to them for use in certain cases. Inasmuch, should a doctor then be forced to utilize a Specific Contact Thrust Procedure (such as a Diversified Technique) and a patient was injured this would raise serious malpractice concerns due to the widespread availability of techniques for the management of the diverse chiropractic patient population. If the Appellate court were to find in favor of the Chiropractic Association of Saskatchewan, banning the use of the Activator Adjustment in Saskatchewan by doctors of chiropractic, it not only provide a risk to the general public by removing the doctors right to utilize a lower force technique when clinically indicated, but also inhibit the chiropractors ability to earn a living by not allowing them to treat patients who cannot tolerate or do not desire more forceful types of adjustments. Lastly, It should also be noted as provided in my testimony that chiropractic adjustments have been divided into 4 categories: 1) Specific contact thrust procedures; 2) Non-specific contact thrust procedures; 3) Manual force-mechanically assisted procedures; and 4) Mechanical force-manually assisted procedures. By definition, and as provided in my testimony the Activator adjustment by definition constitutes a "Manual" adjustment. 2. Professional Guidelines. In my testimony, I discussed both the Glenerin and Mercy Center Conferences, where experts in the chiropractic profession have convened to review the scientific and professional literature to create standards of professional care. From this work, professional guidelines have been created for both Canadian (Glenerin) and U.S. (Mercy) chiropractors. In both guidelines, chiropractic techniques have been defined, and reviewed for their efficacy based upon the data available. It should be noted that Dr.Cassidy was a participant in this process, and also that the Activator adjustment was categorized, and classified according the available data at that time by the professional expert panels. 3. Efficacy of the Activator Adjustment Basic Science Evidence In my testimony, I provided a review of the literature of the basic science evidence relating to chiropractic adjustments. I submitted peer-reviewed indexed biomedical journal articles that report that the thrust provided by the Activator Adjusting Instrument (AAI) results in significant bone movement (Smithet al., 1989;Fuhr and Smith, 1986;Nathan and Keller, 1994). This data demonstrates biomechanically that adjustment is accomplished with the AAI. I also presented evidence that the AAI adjustment results in distinguishable physiologic responses in patients (Herzog,1996;Colloca et al., 1999;Colloca et al., 2000a). Such responses are thought to provide the basic mechanisms of how adjustments work - improving spinal motion and inhibiting of hyperactive spinal musculature and inhibition of pain nerves. It should be reiterated that Dr.Nykoliation admitted in his testimony that there was basic science evidence to support the physiologic basis of the Activator thrust. It should be noted that since my testimony in February, 1999, several other papers have appeared providing further support for the consistent neuromuscular reflex responses associated with AAI adjustments (Colloca and Keller, 2000;Colloca et al., 2000b;Keller and Colloca, 2000a;Keller and Colloca, 2000b;Colloca et al., 2000c;Colloca et al., 2000a;Symons et al., 2000). Clinical Outcome Studies In my testimony I provided the only studies that were available to date comparing outcomes among chiropractic techniques including Activator (Gemmell and Jacobson,1995;Yurkiw and Mior, 1996;Yates et al., 1988). From the only data available, we can conclude that there is no difference in patient outcome in patients receiving Specific Contact Thrust (Meric or Diversified) procedures or Mechanical Force, Manually-Assisted procedures. Since my testimony, another randomized, comparative trial has appeared that found the same conclusions (Wood and Mathews, 1999;Wood et al., 2000). Despite the fact that Drs. Nykoliation and Cassidy criticize the small sample sizes and number of treatments in these studies, the fact remains that the only available data available demonstrates that patients receiving Activator adjustments fair just as well as patients receiving more traditional types chiropractic adjustments. Moreover, no study exists that demonstrates a superior benefit of Specific Contact Thrust adjustments over Mechanical Force, Manually-Assisted adjustments. You correctly point out that clinical practice is both an art and science and that the treatment decisions are made on sound clinical judgment on the part of the practitioner. Drs. Nykoliation and Cassidy both provide testimony that they believe that the Activator adjustment should be banned because there is not enough scientific evidence available inthe form of randomized controlled clinical trials. However, ironically, in cross-examination, both of them admitted to using chiropractic procedures in which there are no RCTs available (i.e. Manipulation in patients with radicular pain, and in applying manipulation to the thoracic spine). This further illustrates the widely accepted professional opinion that although RCTs are important, they do not constitute a requirement for a particular clinical procedure to be performed on a patient. You correctly illustrate that this same standard is held in Medicine for clinical procedures as well. In summary, the use of the Activator adjustment by chiropractors should not be held to a different standard to that of other clinical procedures. Moreover, in my testimony I provided a number of clinical studies that support the use of the Activator instrument in providing successful chiropractic adjustment of variety of patients complaints (Osterbauer et al., 1993;Frach et al., 1992;Polkinghorn and Colloca, 1998;Polkinghorn,1998;Polkinghorn and Colloca, 1999). Clinical studies ranging from case reports to comparative clinical trials all add to the knowledge base that continues to shape clinical practice. Professional Association Conduct David, I share your concern about the CAS making the claim that the court should not interfere with recommendations made by the Professional Association in the province. This, is my only fear in our appeal. I will leave it to you from a political standpoint to best word our feelings on this issue. From all of our discussions, and my testimony, it is clear that the CAS is basing it¼s opinions on the use of the Activator Adjusting Instrument on the biased opinions of some of its leaders. Clearly, they are attempting to hold the AAI to a different standard than that of other commonly used clinical procedures in all of health care including chiropractic. I sincerely hope that my contributions help secure our victory over the appeal filed in Saskatchewan. Please inform the courageous chiropractors who have been persecuted by their own association that my services are complimentary. This is my way of acknowledging their integrity and my support oftheir cause. Please do not hesitate to contact my office should you wish to discuss my report or any other issue relating to this case. Sincerely, Christopher J. Colloca, D.C. ****************************************************** ****** Christopher J. Colloca, D.C. 11011 S. 48th St., Suite 205 Phoenix, AZ 85044 Phone: (480) 893-2400 Mobil: (602) 738-7241 Fax: (480) 893-2412 cjcolloca@neuromechanical.com www.neuromechanical.com ****************************************************** ***** References Colloca,C.J.& Fuhr,A.W., 1997. Safety in chiropractic practice. Part II: Treatment to the upper neck and the rate of cerebrovascular incidents [letter;comment]. J.Manipulative.Physiol.Ther., 20,(8), 567- 568. Colloca,C.J.& Keller,T.S., 2001. Electromyographic reflex response to mechanical force, manually-assisted spinal manipulativetherapy. Spine 2001, in press. Colloca,C.J.,Keller,T.S., Gunzburg,R., Vandeputte,K.,Fuhr,A.W., 2000a. Neurophysiologic response to intraoperative lumbosacral spinal manipulation. J Manipulative Physiol Ther, 23,(7), 447-457. Colloca CJ, Keller TS, Seltzer DE, FuhrAW. Electromyographic responses to mechanical force, manually assessed spinal manipulative therapy. Proceedings of the 27th Annual Meeting of the International Society for the Study of the Lumbar Spine, Adelaide, Australia, April 9-13, 2000. Colloca CJ, Keller TS, Seltzer DE, Fuhr AW. Lumbar erector spinae reflex responses to mechanical force, manually-assisted thoracolumbar and sacroiliac joint manipulation in patients with low back pain. Proceedings of the 2000 International Conference on Spinal Manipulation, Bloomington, MN, September 21-23, 2000: 20-2. Colloca CJ, Keller TS, Fuhr AW. Muscular and mechanical behavior of the lumbar spine in response to dynamic posteroanterior forces. Proceedings of the 26th Annual Meeting of the International Society for the Study of the Lumbar Spine, Kona, Hawaii. Toronto: ISSLS; 1999: p.136A. Frach,J.P.,Osterbauer,P.J., Fuhr,A.W., 1992. Treatment of Bell's palsy by mechanical force, manually assisted chiropractic adjusting and high-voltage electrotherapy. J.Manipulative.Physiol.Ther., 15,(9), 596-598. Fuhr,A.W.& Smith,D.B., 1986. Accuracy of piezoelectric accelerometers measuring displacement of a spinal adjusting instrument.J.Manipulative.Physiol.Ther.,9,(1), 15-21. Gemmell,H.A.& Jacobson,B.H., 1995. The immediate effect of Activator vs. Meric adjustment on acute low back pain: a randomized controlled trial. JManipulative.Physiol Ther., 18, 453-456. Herzog,W.,1996. Mechanical, Physiologic, and Neuromuscular Considerations of Chiropractic Treatments. In: Lawrence,D.J., Cassidy,J.D.,McGregor,M., Meeker,W.C.,Vernon,H.T. (Eds.), Advances in Chiropractic, pp.269-285. Mosby-Year Book, Inc., St. Louis. Keller,T.S.& Colloca,C.J., 2000b. Mechanical force spinal manipulation increases trunk muscle strength assessed by electromyography: A comparative clinical trial. J Manipulative Physiol Ther.,in press (Dec.). Keller TS, Colloca CJ. Mechanical force spinal manipulation increases trunk muscle strength assessed by electromyography: A comparative controlled clinical trial. Proceedings of the 27th Annual Meetingof the International Society for the Study of the Lumbar Spine, Adelaide, Australia, April 9-13, 2000. Nathan,M.& Keller,T.S., 1994. Measurement and analysis of the in vivo posteroanterior impulse response of the human thoracolumbar spine: a feasibility study. J.Manipulative.Physiol Ther., 17,(7), 431-441. Osterbauer,P.J.,De Boer,K.F., Widmaier,R., Petermann,E.,Fuhr,A.W., 1993. Treatment and biomechanical assessment of patients with chronic sacroiliac joint syndrome. J.Manipulative.Physiol.Ther., 16,(2), 82-90. Polkinghorn,B.S.,1998. Treatment of cervical disc protrusions via instrumental chiropractic adjustment. J Manipulative Physiol Ther., 21,(2), 114-121. Polkinghorn,B.S.& Colloca,C.J., 1998. Treatment of symptomatic lumbar disc herniation using activator methods chiropractic technique. J Manipulative Physiol Ther, 21,(3),187-196. Polkinghorn,B.S.& Colloca,C.J., 1999. Chiropractic treatment of coccygodynia via instrumental adjusting procedures using activator methods chiropractic technique. J Manipulative.Physiol Ther., 22,(6), 411-416. Slosberg,M.,1994. Side posture manipulation for lumbar intervertebral disk herniation reconsidered. J Manipulative.Physiol Ther.,17,(4), 258-262. Smith,D.B.,Fuhr,A.W., Davis,B.P., 1989. Skin accelerometer displacement and relative bone movement of adjacent vertebrae in response to chiropractic percussion thrusts. J.Manipulative.Physiol.Ther., 12,(1), 26-37. Symons,B.P.,Herzog,W., Leonard,T., Nguyen,H., 2000. Reflex responses associated with activator treatment. J Manipulative Physiol Ther.,23,(3), 155-159. Wood TG, Matthews R. A clinical trial investigating the relative effect of an instrumental as opposed to a manual thrust manipulation in the treatment of cervical spine dysfunction - A pilot study. Proceedings of the 5th Biennial Congress of the World Federation ofChiropractic, May 17-22, 1999:249. Wood,T.G.,Colloca,C.J., Matthews,R., 2000. A pilot randomized clinical trial on the relative effect of instrumental (MFMA) versus manual (HVLA) manipulation in the treatment of cervical spine dysfunction. J Manipulative Physiol Ther, in press. Yates,R.G.,Lamping,D.L., Abram,N.L., Wright,C., 1988. Effects of Chiropractic Treatment on Blood Pressure and Anxiety: a Randomized Controlled Trial. J Manipulative Physiol Ther, 11,(6), 484-488. Yurkiw,D.& Mior,S., 1996. Comparison of two chiropractic techniques on pain and lateral flexion in neck pain patients: apilot study. Chiropr Tech, 8,(4),155-162. ************************************************* Christopher J. Colloca, D.C. 11011 S. 48th St., Suite 205 Phoenix, AZ 85044 U.S.A. Tel. 480-785-8448 Fax. 480-893-2412 Email. CJColloca@neuromechanical.com www.neuromechanical.com ************************