The pyrite standard: the Midas touch in the diagnosis of axial pain syndromes.
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Biomedical subjects
Publications and source records attributed to Scott Haldeman.
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OBJECTIVE: To study the side effects and adverse events related to intraligamentous injection of sclerosing solutions (prolotherapy) for back and neck pain. DESIGN: Practitioner postal survey. SETTING: Postal survey of practitioners of prolotherapy for back and neck pain in the United States and Canada. PARTICIPANTS: A sample of prolotherapy practitioners from 2 professional organizations were surveyed about their training and experience, use of specific treatment procedures, estimated prevalence of side effects, and adverse events related to prolotherapy for back and neck pain. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Prevalence of side effects and adverse events. RESULTS: Surveys were completed by 171 practitioners (response rate, 50%). Ninety-eight percent held medical degrees, and 83% were board certified in various disciplines. Respondents had a median of 10 years of experience, during which they had treated a median of 500 patients and given a median of 2000 treatments. Side effects with the highest median estimated prevalence were pain (70%), stiffness (25%), and bruising (5%). There were 472 reports of adverse events, including 69 that required hospitalization and 5 that resulted in permanent injury secondary to nerve injury. The vast majority (80%) were related to needle injuries such as spinal headache (n = 164), pneumothorax (n=123), temporary systemic reactions (n = 73), nerve damage (n = 54), hemorrhage (n = 27), nonsevere spinal cord insult (ie, meningitis, paralysis, spinal cord injury) (n = 9), and disk injury (n = 2). CONCLUSIONS: Side effects related to prolotherapy for back and neck pain, such as temporary postinjection pain, stiffness, and bruising, are common and benign. Adverse events related to prolotherapy for back and neck pain are similar in nature to other widely used spinal injection procedures. Further study is needed to fully describe the adverse event profile of prolotherapy for back and neck pain.
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We present a theoretical etiologic model of cervical artery dissection for the purpose of coalescing our present understanding of its pathogenesis. Although the notion of an underlying arteriopathy and a trigger are universally accepted concepts, we propose in our model that dissection is a product of an underlying (genetic) predisposition, triggered specifically by risk factors associated with environmental exposure, with or without trivial trauma. Given the widespread daily occurrence of neck movements and sporting activities, it seems unlikely that trivial trauma, in the absence of other triggers and an underlying arteriopathy, is sufficient to cause dissection. This concept has significant implications for practitioners of spinal manipulation. This may represent a paradigm shift because the model suggests that stroke following manipulation is unlikely in otherwise healthy individuals. Although this model is consistent with current published case-control studies on cervical artery dissection, further research is necessary to accept or refute it as a tenable hypothesis.
BACKGROUND AND PURPOSE: Cervical artery dissection (CAD) is a recognized cause of ischemic stroke among young and middle-aged individuals. The pathogenesis of dissections is unknown, although numerous constitutional and environmental risk factors have been postulated. To better understand the quality and nature of the research on the pathogenesis of CAD, we performed a systematic review of its risk factors. METHODS: PubMed [MEDLINE (1966 to February 22, 2005)] and Embase (1980 to February 22, 2005) were searched to identify studies fulfilling the inclusion criteria. Two reviewers independently assessed methodological quality of the primary studies. Relevant data were extracted, including the risk factor(s) investigated, characteristics of the study population, and strength of the association(s). RESULTS: Thirty-one case-control studies were included for analysis. Selection bias, lack of control for confounding, and inadequate method of data analysis were the most common identified methodological shortcomings. Strong associations were reported from individual studies for the following risk factors: aortic root diameter >34 mm (odds ratio [OR=14.2; 95% confidence interval [CI], 3.2 to 63.6), migraine (ORadj, 3.6; 95% CI, 1.5 to 8.6), relative diameter change (>11.8%) during the cardiac cycle of the common carotid artery (ORadj, 10.0; 95% CI, 1.8 to 54.2), and trivial trauma (in the form of manipulative therapy of the neck) (ORadj, 3.8; 95% CI, 1.3 to 11). A weak association was found for homocysteine (2 studies: ORcrude, unknown; 95% CI, 1.05 to 1.52; ORcrude, 1.3; 95% CI, 1.0 to 1.7), and recent infection (ORadj, 1.60; 95% CI, 0.67 to 3.80). Two studies had conflicting findings for low levels of alpha1-antitrypsin, with the methodologically stronger study suggesting no association with CAD. CONCLUSIONS: CAD is a multi-factorial disease. Many of the reviewed studies contained 2 or more major sources of bias commonly found in case-control studies. Only one study (of homocysteine) used healthy controls, a robust sample size, and had a low risk of biased results. The relationship between atherosclerosis and CAD has been insufficiently examined.
OBJECTIVES: To measure changes in pain and disability for chronic low-back pain patients receiving treatment with medication-assisted manipulation (MAM) and to compare these to changes in a group only receiving spinal manipulation. STUDY DESIGN: Prospective cohort study of 68 chronic low-back pain patients. METHODS: Outcomes were measured using the 1998 Version 2.0 American Association of Orthopaedic Surgeons/Council of Musculoskeletal Specialty Societies/Council of Spine Societies Outcomes Data Collection Instruments. The primary outcome variable was change in pain and disability. All patients received an initial 4- to 6-week trial of spinal manipulation therapy (SMT), after which 42 patients received supplemental intervention with MAM and the remaining 26 patients continued with SMT. RESULTS: Low back pain and disability measures favored the MAM group over the SMT-only group at 3 months (adjusted mean difference of 4.4 points on a 100-point scale, 95% confidence interval [CI] -2.2 to 11.0). This difference attenuated at 1 year (adjusted mean difference of 0.3 points, 95% CI -8.6 to 9.2). The relative odds of experiencing a 10-point improvement in pain and disability favored the MAM group at 3 months (odds ratio 4.1, 95% CI 1.3-13.6) and at 1 year (odds ratio 1.9, 95% CI 0.6-6.5). CONCLUSION: Medication-assisted manipulation appears to offer some patients increased improvement in low back pain and disability. Further investigation of these apparent benefits in a randomized clinical trial is warranted.
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Chiropractic is a large and well-established health care profession in the United States. In this overview, we briefly examine the development of chiropractic from humble and contentious beginnings to its current state at the crossroads of alternative and mainstream medicine. Chiropractic has taken on many of the attributes of an established profession, improving its educational and licensing systems and substantially increasing its market share in the past two decades. The public increasingly uses chiropractic largely for spinal pain syndromes and appears to be highly satisfied with the results. Of all the so-called alternative professions, chiropractic has made the largest inroads into private and public health care financing systems and is increasingly viewed as an effective specialty by many in the medical profession. Much of the positive evolution of chiropractic can be ascribed to a quarter century-long research effort focused on the core chiropractic procedure of spinal manipulation. This effort has helped bring spinal manipulation out of the investigational category to become one of the most studied forms of conservative treatment for spinal pain. Chiropractic theory is still controversial, but recent expansion in federal support of chiropractic research bodes well for further scientific development. The medical establishment has not yet fully accepted chiropractic as a mainstream form of care. The next decade should determine whether chiropractic maintains the trappings of an alternative health care profession or becomes fully integrated into all health care systems.
STUDY DESIGN: A retrospective review of 64 medicolegal records describing cerebrovascular ischemia after cervical spine manipulation was conducted. OBJECTIVES: To describe 64 cases of cerebrovascular accidents temporally associated with cervical spine manipulation therapy in terms of patient characteristics, potential risk factors, nature of complication, and neurologic sequelae. SUMMARY OF BACKGROUND DATA: Approximately 117 cases of postmanipulation cerebrovascular ischemia have been reported in the English language literature. Proposed risk factors include age, gender, migraine headaches, hypertension, diabetes, birth control pills, cervical spondylosis, and smoking. It is often assumed that these complications may be avoided by clinically screening patients and by premanipulation positioning of the head and neck to evaluate the patency of the vertebral arteries. METHODS: Three researchers using a uniform data abstraction instrument performed an independent review of 64 previously unpublished medicolegal records describing cerebrovascular ischemia after cervical spine manipulation. These cases were referred to a single physician for review over a 16-year period from across the United States and Canada. Descriptive statistics were calculated for characteristics of the patients and the complications. Means and standard deviations were computed for continuous variables. Frequencies and proportions were calculated for categorical variables. RESULTS: This study was unable to identify factors from the clinical history and physical examination of the patient that would assist a physician attempting to isolate the patient at risk of cerebral ischemia after cervical manipulation. CONCLUSION: Cerebrovascular accidents after manipulation appear to be unpredictable and should be considered an inherent, idiosyncratic, and rare complication of this treatment approach.
Stroke represents an infrequent adverse reaction associated with cervical spine manipulation therapy. Attempts to identify the patient at risk and the type of manipulation most likely to result in these complications of manipulation have not been successful. A retrospective review of 64 medical legal cases of stroke temporally associated with cervical spine manipulation was performed to evaluate characteristics of the treatment rendered and the presenting complaints in patients reporting these complications. These files included records from the practitioner who administered the manipulation therapy, post stroke testing and treatment records usually by a neurologist, and depositions of the patient and the practitioner of manipulation as well as expert and treating physicians. A retrospective review of the files was carried out by three (two in 11 cases) researchers using the same data abstraction instrument to independently assess each case. These independent reviews were followed by a consensus review in which all reviewers reached agreement on file content. Ninety two percent of cases presented with a history of head and/or neck pain and 16 (25 %) cases presented with sudden onset of new and unusual headache and neck pain often associated with other neurological symptoms that may represent a dissection in progress. The strokes occurred at any point during the course of treatment. Certain patients reporting onset of symptoms immediately after first treatment while in others the dissection occurred after multiple manipulations. There was no apparent dose-response relationship to these complications. These strokes were noted following any form of standard cervical manipulation technique including rotation, extension, lateral flexion and non-force and neutral position manipulations. The results of this study suggest that stroke, particularly vertebrobasilar dissection, should be considered a random and unpredictable complication of any neck movement including cervical manipulation. They may occur at any point in the course of treatment with virtually any method of cervical manipulation. The sudden onset of acute and unusual neck and/or head pain may represent a dissection in progress and be the reason a patient seeks manipulative therapy that then serves as the final insult to the vessel leading to ischemia.
Chiropractic is now more than a century old, and it is licensed throughout the United States and Canada and recognized in more than 60 countries worldwide. Doctors of Chiropractic receive training that is focused on the treatment of NMS conditions through manual and physical procedures, such as manipulation, massage, exercise, and nutrition. Most patients present to chiropractors with low back pain, neck pain, whiplash, and headaches. Numerous studies and expert panel reviews have supported the use of chiropractic and manipulation for these complaints. Satisfaction with chiropractic care for low back pain typically is good. Chiropractic, in general, offers safe and cost-effective procedures for selected musculoskeletal problems.
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BACKGROUND CONTEXT: The injection of various solutions aimed at producing a sclerosing effect has been used to treat soft tissues injuries (eg, inguinal hernia) for more than 100 years. In the 1930s, this treatment approach was applied to injured joints in an attempt to stimulate connective tissue repair. Although several studies have been published about this method of treatment for various orthopedic and spinal indications (termed prolotherapy), its use remains controversial. PURPOSE: To conduct a critical review of the literature on prolotherapy for spinal pain. STUDY DESIGN/SETTING: Critical review of the literature. METHODS: Computerized medical literature databases (Medline, CINAHL, Mantis, Cochrane Central Register of Controlled Trials) were searched to uncover all published information about the use of sclerosing injections in humans with spinal pain disorders. Search results were reviewed for relevance, and information was abstracted from full-text articles. RESULTS: Our search uncovered almost 200 reference materials in various media related to prolotherapy, including 31 clinical studies related to spinal pain. There were 26 observational cohorts and 5 randomized clinical trials (RCTs). Indications in these studies were low back pain (22), neck pain (3), cervical headaches (3) and dorsal or thoracic pain (3). A total of 20 sclerosing solutions were used in these studies; the most common was a mixture of dextrose 12.5%, glycerin 12.5%, phenol 1.25% and lidocaine 0.25%. Wide variations were found in treatment protocols, such as dose, number of treatments and use of adjunct therapies. Most cohort studies were only of moderate quality and varied greatly in the substances injected and the use of co-interventions. Most clinical studies reported positive results such as decreased pain or disability, although differences between treatment and control groups did not always reach statistical significance. Commonly reported adverse reactions to this treatment include temporary postinjection pain and stiffness. A handful of more serious adverse events were reported in the 1950s and 1960s with stronger or unknown solutions. CONCLUSION: Prolotherapy describes a variety of treatment approaches rather than a specific protocol. Results from clinical studies published to date indicate that it may be effective at reducing spinal pain. Great variation was found in the injection and treatment protocols used in these studies that preclude definite conclusions. Future research should focus on those solutions and protocols that are most commonly used in clinical practice and have been used in trials reporting effectiveness to help determine which patients, if any, are most likely to benefit from this treatment.
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BACKGROUND CONTEXT: The acceptance of spinal manipulation as a reasonable method of treating certain patients with spinal pain over the past decade has led to a renewed interest and increased use of these techniques performed in conjunction with commonly used medications and procedures. Manual therapy is increasingly being used in conjunction with anesthetics, sedatives or analgesics as well as local, epidural and intra-articular injections. PURPOSE: This report provides a review of the literature and presents a description of current clinical practice methods for the application of the different techniques of medication-assisted spinal manipulation therapy followed by a discussion of the current clinical support and the published indications, contraindications and complications for each of these procedures. STUDY DESIGN/SETTING: This technical report integrates a literature review with information gathered through personal interviews, review of medicine-assisted manipulation courses and observations of clinical procedures. METHODS: A PubMed search from 1966 to the present was performed to identify appropriate articles concerning the combination of spinal manipulation therapy with such medical procedures as the use of anesthetic, conscious sedation, local injection of analgesic, anti-inflammatory and proliferant agents and intra-articular injections. Additional articles and information were gathered through review of pertinent references, attendance of various technique specific seminars and communication with experts familiar with these procedures. RESULTS: Four categories of medication-assisted manipulation were identified: manipulation under general anesthesia or sedation, manipulation under epidural anesthesia with or without epidural steroid injection, manipulation under joint anesthesia/analgesia, and manipulation with injectants, such as steroids or proliferant agents. The literature consists primarily of case reports and case series with two randomized controlled trials and one cohort study. CONCLUSIONS: Medicine-assisted spinal manipulation therapies have a relatively long history of clinical use and have been reported in the literature for over 70 years. However, evidence for the effectiveness of these protocols remains largely anecdotal, based on case series mimicking many other surgical and conservative approaches for the treatment of chronic pain syndromes of musculoskeletal origin. There is, however, sufficient theoretical basis and positive results from case series to warrant further controlled trials on these techniques.
BACKGROUND CONTEXT: The growing recognition of cervical manipulation as a treatment of neck pain and cervicogenic headaches has lead to increased interest in potential complications that may result from this treatment approach. Recent surveys have reported that many neurologists will encounter cases of vertebral artery dissection that occur at various times after cervical manipulation, whereas most practitioners of spinal manipulation are of the opinion that these events are extremely rare. We asked the question whether these differences in perception could be explained in part by referral or selection bias. PURPOSE: To assess the effect of referral bias on the differences in perceived incidence of vertebral artery dissection after cervical manipulation between neurologists and chiropractors in Canada. STUDY DESIGN: This study was a retrospective review of cases where neurological symptoms consistent with cerebrovascular ischemia were reported by chiropractors in Canada. METHODS: An analysis of data from a chiropractic malpractice insurance carrier (Canadian Chiropractic Protective Association [CCPA]) and results of a survey of chiropractors was performed to determine the likelihood that a vertebral artery dissection after cervical manipulation would be reported to practicing chiropractors. This was compared with the likelihood that a neurologist would be made aware of such a complication. RESULTS: For the 10-year period 1988 to 1997, there were 23 cases of vertebral artery dissection after cervical manipulation reported to the CCPA that represents 85% of practicing chiropractors in Canada. Based on the survey, an estimated 134,466,765 cervical manipulations were performed during this 10-year period. This gave a calculated rate of vertebral artery dissection after manipulation of 1:5,846,381 cervical manipulations. Based on the number of practicing chiropractors and neurologists during the period of this study, 1 of every 48 chiropractors and one of every two neurologists would have been made aware of a vascular complication from cervical manipulation that was reported to the CCPA during their practice lifetime. CONCLUSIONS: The perceived risk after cervical manipulation by chiropractors and neurologists is related to the probability that a practitioner will be made aware of such an incident. The difference in the number of chiropractors (approximately 3,840 in 1997) and neurologists (approximately 4,000 in 1997) in active practice and the fact that each patient who has a stroke after manipulation will likely be seen by only one chiropractor but by three or more neurologists partly explains the difference in experience and the perception of risk of these two professions. This selection or referral bias is important in shaping the clinical opinions of the various disciplines and distorts discussion on the true incidence of these complications of cervical manipulation. The nature of this study, however, describes the likelihood that a clinician will be made aware of such an event and cannot be interpreted as describing the actual risk of stroke after manipulation.
Proliferol is an investigational new drug containing lidocaine hydrochloride 0.25%, dextrose 12.5%, glycerin 12.5%, and phenol 1.0% in aqueous solution. Despite extensive previous experience with similar drug solutions administered in humans by intraligamentous injection for chronic musculoskeletal conditions for over 50 years, animal toxicity data are unavailable. A pilot study was conducted to assess acute toxic effects prior to undertaking further assessment of this drug. Test animals were four Sprague-Dawley rats and four Yucatan mini-swine. Rats received injections into lumbar paraspinal muscles, whereas swine received injections into lumbosacral ligaments in an attempt to mirror the method of administration in humans. Two doses were studied equivalent to 1x and 5x the typical human dose. Outcomes measured at 24 h and 14 days included clinical observations, clinical chemistry, hematology, urinalysis, local tolerance, and major organ histopathology. In rats and swine, results from clinical chemistry, hematology, and urinalysis were indicative of acute local inflammation. At the high dose, marked (rats) and moderate (swine) short-term above-normal levels in certain liver enzymes were noted. In rats and swine, local tolerance results were indicative of acute local inflammatory changes in the skin, subcutis, and muscle around the injection sites. In rats and swine, major organ histopathology results did not reveal lesions attributable to the drug and clinical observations were within normal limits. In swine, fibroplasia was noted in deeper muscle tissues after 14 days. Injections of Proliferol in lumbar paraspinal muscles in rats and lumbosacral ligaments in swine elicited a modest acute local inflammatory response with no other indications of local or systemic toxicity.
Growing interest in complementary and alternative medicine in the United States has been paralleled by increased use of spinal manipulative therapy in an attempt to manage symptoms of low back pain, spinal stenosis, and spondylolisthesis. Chiropractors have been the main practitioners of spinal manipulative therapy, with osteopaths and physical therapists providing a smaller fraction of these services. Theories explaining the mode of action of spinal manipulative therapy are largely preliminary and have focused on the mechanical effects of manipulative forces on the spine and neurologic responses to manipulation. The effects of spinal manipulation on patients with both acute and chronic low back pain have been investigated in randomized clinical trials. Most reviews of these trials indicate that spinal manipulative therapy provides some short-term benefit to patients, especially with acute low back pain.