Interventional Health, PA Roger H. Coletti, MD, FACC, FASNC, FSCAI

CMECD® History

Roger H. Coletti, MD developer of CMECD®

Roger H. Coletti, MD, FACC, FASNC, FSCAI is a board certified interventional cardiologist who has pioneered a novel treatment for chronic muscle spasm and pain, given the acromym CMECD that stands for "Coletti Method of EMG guided ChemoDenervation". His findings and results have been published in the highly regarded peer reviewed journal, Muscle & Nerve, and presented at national medical meetings. He is currently involved in training physicians and developing clinical research protocols to support its use as an alternative to the use of opioid medications for chronic pain.

CMECD® Dr. Coletti became interested in this area after suffering for decades from low back pain associated with his work. He has done clinical research and has twelve publications in the notable peer reviewed journal "Muscle & Nerve" and has presented his work at four meetings of the American Society of Neuromuscular and Electrodiagnostic Medicine. He has recent articles in the European Journal of Tranlational Myology and the International Journal of Physical Medicine and Rehabilitation. His novel treatment, CMECD®, involves muscular injection while measuring the electrical impulses in the muscle to block the abnormal electrical impulses and stop the chronic spasm. Typically one or two injections is all that is needed for long term relief even if spasm and pain has been present for many years. Surveys of patients treated with this procedure have demonstrated complete and long lasting relief in a high percentage of patients. CMECD® is short for "Coletti Method Emg guided Chemo Denervation". Physicians can find extensive information on the OpioidNo.com web site. Examples of the CMECD® procedure can be seen at https://www.youtube.com/watch?v=fAAfK5n3uP8 and https://www.youtube.com/watch?v=f6npZiwNs7s

PUBLICATIONS

CMECD PUBLICATIONS IN MUSCLE & NERVE

Dr. Coletti became interested in this area after suffering for decades from low back pain associated with his work. He has done clinical research and has twelve publications in the notable peer reviewed journal "Muscle & Nerve" and has presented his work at five meetings of the American Society of Neuromuscular and Electrodiagnostic Medicine. His novel treatment, CMECD®, involves muscular injection while measuring the electrical impulses in the muscle to block the abnormal electrical impulses and stop the chronic spasm. Typically one or two injections is all that is needed for long term relief even if spasm and pain has been present for many years. Surveys of patients treated with this procedure have demonstrated complete and long lasting relief in a high percentage of patients. CMECD® is short for "Coletti Method Emg guided Chemo Denervation". Physicians can find extensive information on the OpioidNo.com web site. Examples of the CMECD® procedure can be seen at https://www.youtube.com/watch?v=fAAfK5n3uP8 and https://www.youtube.com/watch?v=f6npZiwNs7sf

RECENT PULBLISHED ARTICLES

Coletti, R.H. The Ischemic Model of Chronic Muscle Spasm and Pain, Eur. J. Transl. Myol. 2021, 32, https://www.pagepressjournals.org/index.php/bam/article/view/10323. https://pubmed.ncbi.nlm.nih.gov/35044134/

Coletti, R.H. Chronic Muscle Spasm Induced Chronic Pain Treated with the CMECD® Procedure, International Journal of Physical Medicine and Rehabilatation, e Int J Phys Med Rehabil,, Vol.10 Iss.2 No: 630Published: 04-Apr-2022, DOI:10.35248/2329-9096.22.10.6302

Newspaper Article

Dr. Coletti became interested in this area after suffering for decades from low back pain associated with his work. He has done clinical research and has six publications in the notable peer reviewed journal "Muscle & Nerve" and has presented his work at four meetings of the American Society of Neuromuscular and Electrodiagnostic Medicine. His novel treatment, CMECD®, involves muscular injection while measuring the electrical impulses in the muscle to block the abnormal electrical impulses and stop the chronic spasm. Typically one or two injections is all that is needed for long term relief even if spasm and pain has been present for many years. Surveys of patients treated with this procedure have demonstrated complete and long lasting relief in a high percentage of patients. CMECD® is short for "Coletti Method Emg guided Chemo Denervation". Physicians can find extensive information on the OpioidNo.com web site. Examples of the CMECD™ procedure can be seen at https://www.youtube.com/watch?v=fAAfK5n3uP8 and https://www.youtube.com/watch?v=f6npZiwNs7s Interventional Health.com Roger H. Coletti, MD, FACC, FASNC, FSCAI is a board certified interventional cardiologist who has pioneered a novel treatment for chronic muscle spasm and pain, CMECD. His findings and results have been published in the highly regarded peer reviewed journal, Muscle & Nerve, and presented at national medical meetings. He is currently involved in training physicians and developing clinical research protocols to support its use as an alternative to the use of opioid medications for chronic pain. CMECD® Newspaper Article Treatment Outcomes Trained Physicians Cape Gazette Newspaper Article Roger Coletti presents breakthrough treatment of chronic pain at national meeting October 6, 2016 Dr. Roger Coletti of Lewes presented his research findings at The American Association of Neuromuscular and Electrodiagnostic Medicine. Pain from chronic muscle spasm afflicts millions of people and has led to overuse of pain medications with addiction and deaths from overdose. Dr. Roger Coletti of Lewes was able to identify what keeps the muscles in chronic spasm, and he has developed a treatment that turns off the spasm and lets the muscles return to normal function. The trigger that locks the muscles in spasm had not been recognized by other physicians and had been thought to represent simply "noise" in the electrical evaluation of muscle and nerve function. What Coletti found was that this “noise” represented electrical instability of the muscle, keeping the muscle in a state of chronic contraction. He believes that the electrical instability takes place after an initial spasm that choked off the normal blood supply to the muscle causing what is called "membrane instability." This the same sort of thing that happens in the heart muscle, and as a cardiologist Coletti recognized it as the obvious cause of chronic contraction of the muscle. Just as ventricular fibrillation of the heart leaves the heart in a state of quivering, muscle fibrillation, which he calls "myofibrillation," leaves the muscle in a state of chronic contraction. Having found the apparent source of chronic muscle spasm, Coletti then set out to develop a treatment that would return the muscle to normal function. He used a device called an EMG which is the equivalent of an EKG but used to measure electrical activity of nerves and muscles. He researched the work of others in the field of muscle spasm and found several failed attempts which led him to try to complete the work others had abandoned. Initially he found a way to use a very dilute concentration of BOTOX, injecting muscle while looking for the "noise" in the muscle with the EMG. This seemed to work reasonably well but the full effect took weeks to occur and the high cost of BOTOX was never covered by insurance. He then found another medication, phenoxybenzamine, that had been tried for use in chronic muscle spasm and had received three U.S. patents. However, the neurologist who had received those patents ultimately abandoned them without further publication of his work. In the history of medicine, physicians have not uncommonly tried new treatments on themselves before attempting to treat others. As a cardiologist with decades of wearing heavy lead aprons in hospital X-ray rooms, Coletti had plenty of chronic muscle spasms to treat on himself. Working closely with a sterile compounding pharmacy and their advisors, he came up with an appropriate dose concentration of this abandoned medication. After many tries, he incorporated other short-term medications into the injection mix to minimize discomfort and improve outcome. The medication is FDA approved for treating high blood pressure but it had been found in the past to bind to muscle and block electrical activity. Its use as an injection is what is considered an "off-label use." As he has continued to develop his treatment, Coletti has submitted his findings to the medical community. His work has been published in the highly respected, peer-reviewed journal Muscle and Nerve, and he has presented his findings at national meetings of the American Association of Neuromuscular and Electrodiagnostic Medicine. This year at the September meeting, he presented the results of patient satisfaction and assessment surveys documenting long-term relief of pain from chronic muscle spasms lasting over 10 years. It was his method of identifying the presence of chronic muscle spasm that was the title of his presentation. Identifying the muscles that are in chronic spasm is what is required in order to make use of this new method or treatment. 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PRIMARY ABSTRACT REGARDING TREATMENT OF CHRONIC PAIN

LONGSTANDING CHRONIC MUSCLE SPASM SUCCESSFUL TREATMENT OF LONGSTANDING CHRONIC MUSCLE SPASM WITH EMG GUIDED CHEMODENERVATION INTRODUCTION: Chronic muscle spasm represents a significant cause for chronic pain. Treatment of chronic pain with opioid medications has led to opioid addiction, and overdose deaths are currently recognized as a national crisis. Treatment modalities are needed to treat truly chronic pain when associated with chronic muscle spasm. Novel treatment modalities utilizing needle EMG-guided chemodenervation have been previously described. Preliminary assessment of the success of such treatments for longstanding chronic muscle spasm can be provided by patient surveys of such treatment.

OBJECTIVE: To identify success rates of needle EMG-guided chemodenervation with phenoxybenzamine in patients with pain duration of greater than 1 year.

METHODS: Ninety-three sequential patients treated with this technique were surveyed by mail. Forty-two responded.

RESULTS: Of the respondents, 31 (74%) reported years of pain duration Of those, 50% reported complete relief of pain (81% of which reported relief of pain for greater than 3 months) and 27.4% reported moderate relief of pain (44% of which reported pain relief for greater than 3 months). The average duration of pain when specified was 5 years and the longest was 15 years. A single treated patient, not in this survey, reported near complete pain relief and return of function after 35 years.

SUMMARY/CONCLUSION: Truly longstanding chronic muscle spasm and pain can be successfully treated in a significant portion of patients with stable outcomes utilizing the previously described technique of needle EMG-guided chemodenervation with phenoxybenzamine. In this unselected patient population with longstanding chronic pain, results support further clinical research to establish the utility of this treatment modality.

Coletti, R.H., Successful Treatment Of Longstanding Chronic Muscle Spasm With EMG Guided Chemodenervation, Abstract in Muscle & Nerve, Volume 56, Issue 3, September 2017, pages 543-661, Article first published online: 17 AUG 2017, https://www.aanem.org/getmedia/317d32c1-6163-47ff-998e-7046d07ff68f/2017-Abstracts-web.pdf

PATIENT TESTIMONIALS

July 9, 2012: I am an active runner for many years and have done damage to my hip. The pain was so severe that I had to stop running. I lived with this for a few years and one day you men mentioned the treatment you offer. I tried it and it worked! The pain is gone and I am back to running 10 miles per day again.

July 6, 2012: I have had severe back pain for over 15 years. The injections have relieved this pain 100%. I feel like a new person. I used to wake up with major back pain and could barely get out of bed. Now with your treatments, I can jump out of bed and have zero pain! I feel young and vibrant again…it’s simply amazing. For 15 years I could not raise my arm above my head. It forced me to give up golf and working out. Now after the treatments, I go to the gym every day and freely lift weights and exercise without restriction. I am happy to say my handicap is back to 10.

April 18, 2012: Thank you for being the only doctor to analyze my case. I have been in pain for 12 months after chemo and after you injected me, I was on the dance floor. No pain enjoying the life I was made to have. You are a wonderful doctor and made my pain go away (PS. I’m only 22). Thanks for studying my case with the chemo’s aftereffects.

August 17, 2012: I experience extreme back pain. I tried all home remedies to alleviate the pain including but not limited to: aspirin, muscle relaxants, heating pads. I went to see Dr. Coletti on 2/8/12. Dr. Coletti proceeded to give me injections to the painful areas. These injections completely cure the pain and it currently has not returned.Have you opened a new location, redesigned your shop, or added a new product or service?

June 20, 2012: (Hospital CEO) My pain is gone at the injection site. I continue to have numbness in my toes, but I am able to wake up in the morning without any stiffness at all, which is really wonderful. Also, I played golf yesterday and usually when I have finished my back will tighten up and I will need to stretch out before doing anything else…not the case though I feel great.

April 27, 2015: For the past 15 years I have been suffering from extreme neck and back pain with tremendous headaches. All the doctors, who have been many, have said the conditions were cause of arthritis and that nothing could be done. oN April 8, 2015, I received 4 injections in my neck area and on April 23, 2015 one injection. These injections stopped the chronic muscle spasms in my neck and upper back, which resulted in no more neck pain or headaches. After 15 years of suffering this treatment was like a miracle.

August 21, 2016: Thank you for the opportunity to share my experience and significant life changing results that I have experienced from your work. As you know, I had tried many methods of pain relief for my lower back pain. This pain prevented me from walking even a quarter of a block. I was unable to enjoy basic activities such as walking my dog, strolling in the evening on the beach, and even walking around the hospital where I was employed as a chief operating officer. As a board-certified Nurse, I am very aware of treatment options available and actually tried numerous methods of pain relief to include injections, massage, acupuncture, and daily multiple dosing of Motrin. None of these gave me anything but some minor relief that was temporary in nature. Your treatment that you provided me on two occasions was successful in eliminating all of my lower back pain. I no long am in need of any other type of treatment or even intermittent relief from medications. I can’t thank you enough for what you have done for me. (Note: as of January 2022, there was no recurrence of back pain)

On November 16, 2015: I walked into Coletti’s office with extreme pain in both legs, in the hamstring area. After the injections I walked out with no pain. It is now August 23, 2016 and I have not experienced the pain since the injection. August 15, 2016: I developed a very bad case of plantar fasciitis into the fall of 2012. I saw an orthopedic surgeon who specialized in podiatry and was sent to physical therapy. When that failed to work, I was given 3 cortisone injections over a 5 month period. No relief. It was suggested that I have surgery, I declined. I was put on light duty and wore a boot for 2 months. This offered some relief but as soon as the boot came off and I resumed normal activity. I was again in excruciating pain. This pain which went on in first one, then both feet and ankle was intolerable and life limiting. The only thing I could do was get through a day of work, rest my feet at night and repeat. I had to stop all forms of physical activity, I couldn't even take my dog for a short walk or ride a stationary bike. Massage and chiropractor helped a little but after standing all day a work (I am an x-ray tech in a Cardiac Cath Lab) my feet were destroyed. I tried different shoes and orthopedic insoles. Anti inflammatories and tramadol only kept me from wanting to cut my feet off. While describing this pain to a co-worker Dr. Coletti overheard. He explained a procedure he could do that might help. After 3 years of misery, I was willing to anything. One visit to his office, a few injections in my calf (anterior and posterior), one week of leg achiness and my foot/ankle pain was 50% better. Within a month it had improved by 75%. Three months later the pain was almost gone. This was not a 100% cure my feet will hurt after strenuous physical activity or a really bad day at work but so markedly that I tell friends and co-workers that Dr. Coletti saved my life. Before the injection I was in constant pain, miserable and could do nothing and go nowhere without knowing I was going to be in agony. Now I do anything I want. To NOT learn this technique and dismiss it is a huge mistake for the medical community. I thank Dr. Coletti every time I can go for a walk or finish a day of work and I am not in tears from pain.

August 15, 2016: Rising from a seated position was extremely painful. It was difficult to walk after being seated. I can now stand without pain in my back. I still have difficulty walking, however it is because my left knee needs to be replaced. PS Thank you Dr. Coletti.

August 2016: Coletti’s treatment of my sciatica and lower back pain was not only easy but thorough. He injected me at the site of the horrible pain with little discomfort. After the injection I could not feel any pain and walked out of his office as though there never was a problem. Prior to Coletti’s treatment, I had to crawl to the bathroom at night. I highly recommend his technique and treatment to all. No more drugs. Today I am without any pain.

August 2016: Interventional Health has allowed me to continue working daily and so far has avoided back-spine surgery that was scheduled one year ago. Note: recurrence with reinjection in 6/19 and 4/21. Still working as an engine mechanic with heavy lifting and no back surgery as of 3/22.)

March 2016, Staff note: I had the pleasure of working with Dr. Coletti and seeing firsthand the miracles that walked out of our office after the injections. We had patients walk in with a cane or walker and leave with the cane over their shoulder or someone taking their walker out for them. The greatest was hearing the feedback of how positive the long-term affect was and best of all no more pain meds. The success rate was high. Seeing these patients struggle to get out of their chairs and walk down the hallway and walk out a different person and pain free was amazing. Dr. Coletti has created miracles here for patients who had given up hope and he was their last stop.

SURVEY RESULTS

A survey of a cohort of more than 90 patients treated by the CMECD® procedure was performed. During the development of a new treatment strategy, it is not expected that every individual treated will have dramatic outcome results. In the development of the CMECD® procedure over 30 different muscle groups were treated. This procedure involves the identification of chronic muscle spasm by the presence of Spontaneous Electrical Activity (SEA) by EMG and the complete resolution of SEA with EMG guided chemodenervation by use of a phenoxybenzamine/lidocaine/ dexamethasone mixture. The likelihood of universal positive outcomes in a newly developed procedure is highly statistically unlikely.

As has been previously reported, a population of roughly 100 of the most recent individuals that were treated with the CMECD® procedure was surveyed. An initial response to the survey was only 21 individuals. A second survey request, specifically asking for responses of individuals with no pain relief, yielded another 23 responses, 5 of which had no pain relief. The second request was to encourage patients with no benefit to respond to correct the inherent bias of only good outcomes being reported. An initial reporting of the responses was published in abstract form. A selection this data was presented in a recent article “The Ischemic Model of Chronic Muscle Spasm and Pain”.

35 (79.5%) reported one or more years of pain duration, 7 (15.9%) reported months of pain and 2 (4.5%) reported weeks of less pain duration. Of those reporting one or more years of pain, 16 (42.8%) reported complete relief of pain (86.6% of which reported relief of pain for greater than 3 months) and 31.4% reported moderate relief of pain (45.5% of which reported pain relief for greater than 3 months). Of those with one or more years of pain 26(74.3%) reported moderate or complete relief of pain of which 51.4% for greater than 3 months.

Of the patients with prior back surgery 3 of the 7(42%) had durable relief or pain. The number of patients with prior unsuccessful treatments was 41(93.2%). It is notable that 23(52.3%) of the patients had undergone prior epidural injections. The average duration of pain when specified was 6.6 years and the longest was >20 years. A single treated patient, not in this survey, reported near complete pain relief and return of function after 35 years of the 36 patients who noted pain relief, 25 (69.4.%) had relief for >3 month, 6 (18.6%) had relief for 1-3 months, 4 (11%) had relief for 1-4 weeks and 1 had relief for <1 week. Patients with pain relief for one to three months are suspect to gone back to full activity too quickly before the treated muscle had fully recovered.

There was a strong tendency for treated patients to refer others for this treatment. On the survey 17 (38.6%) had already referred, and additional 16 (36.4%) would strongly consider referring and an additional 4 would possibly consider referring while 3 stated that they would not refer. In total 33 (75%) had referred or would strongly consider referring. On the question of impact on overall health, wellbeing, or ability to function 25 (56.8%) noted a major impact, 6 (13.6%) noted a minor impact with the remaining 12 noting none or not reporting. A total of 70.4% noted a minor or major impact on health, wellbeing, or ability to function.

Of the 44 patients reporting, 13 were taking opioid medications, 7 of which came off all medications following the procedure, 1 had a moderate and an additional 5 had a mild reduction in opioid use. A total of 19 (50%) of the 38 patients taking medications came off all pain medications following the procedure. Six patients had reported no use of pain medication prior to the procedure of the 23 patients who underwent epidural injections 12 had complete relief for >3 months, 4 had moderate relief for >3 months and 2 had partial relief for >3 moths. An additional 3 had moderate relief for 1 to 4 weeks. Overall, 19 (82.6%) of the 23 patients who had undergone prior epidural injections had some degree of long-lasting relief and 16 (69.5%) had complete or moderate long-lasting relief. There were 5 treated patients with no pain relief with one injection. Two additional patients were injected twice without relief and subsequently required back surgery. All other patients had pain relief at one or more sites of the 12 (27.2%) patients that had prior back surgery, 3 had complete relief for >3 months, 2 had moderate relief for 1-4 weeks and one had partial relief for <1 week.

Despite the relatively small data set, there is evidence of statistical significance of pain relief with the CMECD® procedure. It also can be noted from the statistical evaluation that sex, age, and duration of pain are not contributing variables. The fact that success of the procedure was not affected by the duration of the chronic pain supports the use of the procedure for individuals for whom there was little hope of success given their duration of their chronic pain. The procedures that generated the results were from a single solo medical practice not primarily involved in pain management or physical rehabilitation is no longer active. As a result, the data collection is complete and cannot be extended as would be preferential for reporting of an experimental procedure. However, despite the obvious shortcomings of the reported data, there is enough information to demonstrate enough cause and effect that it would be negligent not to report it to the medical and scientific community. The current need for treatment of pain without the use of opioid drugs necessitates seeking potential treatment options and for that reason such a treatment option is herein presented.

The successful outcomes of those treated and reported upon notwithstanding, the scientific import of this study is the discovery that SEA is both the presenting and responsible agent for chronic muscle spasm and knowledge of which provides potential treatment pathways. Prior reporting of an ischemic model of chronic muscle spasm provides additional potential pathways for treatment. However, statistics do not tell the whole story and individual reports of long-term outcomes should be given consideration in valuation of this procedure. A selection of patient and staff attestations shown below should provide the believability that statistics always seems to lack. Moreover, the addition of real-life circumstances adds another dimension to what otherwise is mere outcome data.

Survey results indicate the length of time that relief was sustained but not the life impact of that relief. Shown above are a number of self-reporting examples of what should be considered as valuable as pure digital data in a scientific inquire of correlation and causation. As may be seen in the patient testimonials shown above, some of the patients had a life altering change. Not all patients had dramatic results, but as an experimental treatment is undertaken, that would have been unexpected. With more experience in the suitability of injection sites, the proportion of successful results did improve and would be expected to improve further.