This is the third in a series of articles which will attempt to share various concepts of research with doctors in clinical practice and focusing on the value and limitations of case reports. As chiropractic enter the 21st century it is important that chiropractors embrace the advances of what research can offer us. To do this it becomes necessary to be educated clinical practitioners to better discern the value of information yielded from our patient encounters so as to better understand the effects of what we do in practice. Interestingly what we need to use as guides when reading case reports we also need to use when treating patients in our office setting. This is because on some level even patient we sec is a research study in process. We assess what we think is going on with the patient, apply an intervention, and then reassess the patient. But there are ways of looking at our office visits in different ways that may assist us in better grasping what may be actually taking place when we sec a patient. Concepts such as regression to the mean, washout periods, and temporal relationships can assist us when assessing the value of interventions for our patients. Regression to the Mean The term "regression to the mean" is used in statistics to explain that if a patient's first response to an intervention may be highly unusual it may then conimonh be closer to their average on the second. Conversely, if the patient's presentation is highly unusual on the second intervention then it was likely closer to the average on the first. Regression to the mean can compromise any investigation when there is not an appropriate control (group) to assess whether an intervention actually had an affect or if the patient was coincidcntally recovering from an unusual physical episode, regardless of the intervention. Since this is a common effect in research it must be considered with our chiropractic interventions and a patient's response in a clinical setting1. Washout Period A "washout period" is a period in a clinical study during which subjects receive no treatment for their presenting symptoms while under a study and the effects of any previous treatment are eliminated (or assumed to be eliminated)2. Washout periods happen inadvertently such as when a patient positively responds to care, is unable to receive care for a few weeks and notices his/her symptoms worsening. Then when they return and receive care, again the symptoms improve again. In this instance a patients vacation becomes one type of washout period. Temporal Relationship A temporal relationship occurs when an intervention occurs and is presumably closely followed by an effect. In clinical research or even in our clinical practices we tend to assume tliat when a patient lias a response shortly after a treatment tliat their response is related to the treatment. What ultimately becomes important is determining the difference between cause or coincidence. Just because there is a temporal relationship between a treatment and a patients response docs not always mean the treatment caused the effect. Tliat is why we use multiple tools in research or in our office with patients to help determine what works for a patient and what docs not. For that reason we may try to have hesitation before assuming a patient's response to care was not a "regression to the mean." Also before drawing a conclusion about the care rendered we may even want to try a "wash out period" to help discern if the patient may have been getting better even without our care. The following studies from the SOT Research Conferences may help better illustrate these specific concepts. Case Report One3 Case History: A 34-y car-old woman presented for chiropractic care June 2010 with a primary complaint of chronic inner ear congestion of 17-ycar duration. Of interest is that she had other conditions as well: Ehlcrs-Danlos syndrome (HT-EDS). Type II diabetes, migraines, polycystic ovarian syndrome, ecliac disease, and general disoricntatioa Methods/Results: On examination sacro-occipital technique (SOT) indicators diagnosed a sacroiliac joint hypcrmobility syndrome with pelvic torsion (catcgon- two). Cranial palpation revealed sphenoid, right maxilla, and left occiput imbalance. The treatment consisted of SOT psoas release techniques, trapc/ius fiber analysis and treatment, and catcgon two block placement. Cranial therapeutic treatment focused on the sphenoid as well as balancing of dural membrane tensions and CSF pulsations. Within 20-minutcs following the office visit the patient reported that her "car opened up" for the first time in 17 years. The condition was then stable for at least one-week post treatment and the patient did not return for care for follow up assessments. Implications: With this complex case what is interesting is that the patient had a chronic condition for 17 years. During this time it would be expected that issues of regression to the mean and washout periods would have occurred to assess cyclical changes or any prior intcn cntion. Also the persistence of the condition and the response. 20 minutes following care, suggests a temporal relationship between the intcn cntion and her symptomatic response. While she was stable for one week follow ing the treatment, further follow up with this patient would be important to discern if the positive response was sustained. Case Report Two4 Case History: Asthma is a multifactorial dysfunction which may need interdisciplinary care for comprehensive treatment. The patient is a 63-year-old active female. 5'3".112 lb rating her general health level as a 9/10. with her only discomfort being a long history of asthma and shortness of breath. Methods/Results: Chiropractic interventions involved sacro-occipital technique catcgon one treatment, reduction of costal torsion (T3-6). diaphragm and craniofacial balancing. Acupuncture treatment focused on the lungs points to "open the chest." and master empirical points for the head, neck and sinuses were also used. Follow ing treatment the patient could return to her full activities of daily living, eliminated the need of her asthma medication, and was able to respond to stressful situations without asthma llarc-ups. With periodic supportive care5 the patient's symptoms were controlled, with llarc-ups only occurring when length between treatments exceeded more than 4-6 weeks. Implications: With regression to the mean we could expect cyclical improvements and worsening of a patient's condition without care, yet if treatment was effective we would expect a relationship of improvement with treatment and worsening as time between treatment increases. On some level a washout period was occurring between office visits and an optimal period of time for when treatment was needed became apparent. Supportive care5 is an important concept for treatment of long term chronic conditions which have been unresponsive to other interventions. Supportive care differs from maintenance care in that it is based on minimal needed care to sustain a patient's activity of daily living and quality of life. Case Report Two6 Case History: A 54-year-old male patient presented with severe pain in the epigastric area worse with deep breathing, eating any food, unremitting persistent upper abdominal aching, fullness, and throbbing pain. The patient was unable to sleep due to pain, and nothing he could do would relieve his pain or discomfort. The condition had persisted for three-days before he sought treatment at this office. Methods/Results: Treatment involved adjustment of "anteriorities" in the T11-L2 region, releasing of diaphragmatic tension in the mid and left lower rib region, sacro occipital technique (SOT) chiropractic manipulative re Ilex technique (CMRT) hiatal hernia release technique (gently pulling stomach downwards during exhalation) and solar plexus technique. Immediately upon pulling the stomach downward the patient sighed and said he could breathe comfortably for the first time in three days and approximately 2-minutcs later the constant tension in the epigastric region was also gone. A week follow ing he indicated he was eating and functioning normally without discomfort and at 2-year follow-up indicated the condition had never returned. Implications: The temporal relationship between the unremitting discomfort the patient experienced for days, the treatment, and immediate response is compelling to suggest that there was a cause and effect to the intervention. Chiropractic care for non-musculoskclctal conditions is a challenging hill to climb from a research standpoint because sometimes non-musculoskclctal conditions arc diffuse and chiropractic treatment may have a non-specific but positive effect. Using concepts of regression to the mean, washout periods, and temporal relationships can help us better assess case reports and their significance as well as what is taking place in our office with our patients. It is always important to question whether what you arc doing thcrapcuticalh is actualh creating the change that you presume is happening. This self questioning strategy may help you discern how often you actually need to see a patient, how to develop crgonomic modifications or rehabilitative exercises for your patient, and if you may need to co-treat with another practitioner. In the next article I will be discussing chiropractic care of non-musculoskclctal conditions the challenges and the successes. References: 1. Shephard K.J. Regression to the mean. A threat to exercise sci ence? Sports Med. 2003:33(8):575-84. 2. [htlp: medical-dictionarv.lhefreedictionarv.com/ washout period/ Last Accessed January 22, 2014. 3. Colman M, Blum CL. Chronic inner ear congestion of 17 years relieved by Sacro Occipital Technique (SOT) chiropractic care: A case report. 2nd Annual Sacro Occipital Technique Research Conference Proceedings: Sew Orleans, LI. 2010:S3-5. 4. Benner CD, Blum CL. Integrating SOT and acupuncture for the treatment of asthma: A case report. 2nd Annual Sacro Occipital Technique Research Conference Proceedings: New Orleans, LA. 2010: 58-61. ('rawfordM. Supportive care: an important notion in third-party payers cases. ChiroJAust. 1997 27(1): 18-19. Mitchell GA, Blum CL. Sacro occipital technique treatment of hiatal (hiatus) hernia presentation: A case report. 1st Annual Sacro Occipital Technique Research Conference Proceedings: Las legas, Ni: 2009: 62-4. Charles /,. Blum, DCis in private practice Santa \ fonica, California, director of research for Sacro Occipital Technique Organization - USA, adjunct research faculty at C leve-land C luropractic College and teaches the Sacro Occipital Technique (SOT) elective class at Palmer College ofCliimpractic-West and Southern California I'niversity of Health Sciences.
