Outcomes of usual chiropractic, harm & efficacy, the ouch study: study protocol for a randomized controlled trial.

BACKGROUND: Previous studies have demonstrated that adverse events occur during chiropractic treatment. However, because of these studies design we do not know the frequency and extent of these events when compared to sham treatment. The principal aims of this study are to establish the frequency and severity of adverse effects from short term usual chiropractic treatment of the spine when compared to a sham treatment group. The secondary aim of this study is to establish the efficacy of usual short term chiropractic care for spinal pain when compared to a sham intervention. METHODS: One hundred and eighty participants will be randomly allocated to either usual chiropractic care or a sham intervention group. To be considered for inclusion the participants must have experienced non-specific spinal pain for at least one week. The study will be conducted at the clinics of registered chiropractors in Western Australia. Participants in each group will receive two treatments at intervals no less than one week. For the usual chiropractic care group, the selection of therapeutic techniques will be left to the chiropractors' discretion. For the sham intervention group, de-tuned ultrasound and de-tuned activator treatment will be applied by the chiropractors to the regions where spinal pain is experienced. Adverse events will be assessed two days after each appointment using a questionnaire developed for this study. The efficacy of short term chiropractic care for spinal pain will be examined at two week follow-up by assessing pain, physical function, minimum acceptable outcome, and satisfaction with care, with the use of the following outcome measures: Numerical Rating Scale, Functional Rating Index, Neck Disability Index, Minimum Acceptable Outcome Questionnaire, Oswestry Disability Index, and a global measure of treatment satisfaction. The statistician, outcome assessor, and participants will be blinded to treatment allocation. TRIAL REGISTRATION: Australia and New Zealand Clinical Trials Register (ANZCTR): ACTRN12611000542998.

The safety and effectiveness of pediatric chiropractic: a survey of chiropractors and parents in a practice-based research network.

BACKGROUND: With continued popularity of complementary and alternative medicine (CAM) therapies for children, their safety and effectiveness are of high concern for both CAM and conventional therapy providers. Chiropractic is the most popular form of practitioner-based CAM therapies for children. OBJECTIVE: The objective of this study was to describe the practice of pediatric chiropractic, including its safety and effectiveness. DESIGN: This study used a cross-sectional survey. SETTING: A practice-based research network was used for this study. PATIENTS/PARTICIPANTS: Participants were chiropractors and parents of pediatric patients (aged < or =18 years) attending chiropractic visits ranging from one to 12 visits. INTERVENTION: This is a survey study. No interventions were rendered in the completion of this study. MAIN OUTCOME MEASURES: Demographics, clinical presentations, treatment-associated aggravations, complications and improvements. RESULTS: The indicated primary reason for chiropractic care of children was "wellness care." With respect to condition-based presentations, musculoskeletal conditions were the most common, in addition to nonmusculoskeletal conditions of childhood. The most common techniques used were diversified technique, Gonstead technique, Thompson technique, and activator methods. Treatment-associated complications were not indicated by the chiropractic and parent responders. Chiropractor responders indicated three adverse events per 5,438 office visits from the treatment of 577 children. The parent responders indicated two adverse events from 1,735 office visits involving the care of 239 children. Both sets of responders indicated a high rate of improvement with respect to the children's presenting complaints, in addition to salutary effects unrelated to the children's initial clinical presentations.

A model framework for patient safety training in chiropractic: a literature synthesis.

OBJECTIVE: The objective of this review is to develop an evidence-focused and work-based model framework for patient safety training, that is, reporting and learning from adverse events in chiropractic care. This article will not debate specific issues of adverse events from spinal manipulation. The main focus is on education for patient safety. METHODS: We conducted a systematic search and synthesized 196 articles on patient safety to provide guidance. The review was carried out by the 2 authors independently in 3 ways: research type, relevancy with respect to patient safety, safety culture or climate, and distinct description of one or more of the adapted Bland's characteristics. RESULTS: Fifty-five articles were included. Their review provided knowledge acquisition and practice behavior regarding patient safety issues and excellent baseline data on reporting and learning of adverse events for training purpose. CONCLUSIONS: Leadership, commitment, and communication together with trust and openness to build a culture of patient safety are prerequisites for successful reporting and learning.

A randomized, placebo-controlled clinical trial of chiropractic and medical prophylactic treatment of adults with tension-type headache: results from a stopped trial.

OBJECTIVES: Tension-type headache (TTH) is the most common headache experienced by adults in Western society. Only 2 clinical trials of spinal manipulation for adult tension-type headache have been reported, neither of which was fully controlled. In 1 trial, spinal manipulation was compared to amitriptyline. There is an urgent need for well-controlled studies of chiropractic spinal manipulation for TTH. This trial was stopped prematurely due to poor recruitment. The purposes of this report are (1) to describe the trial protocol, as it contained several novel features, (2) to report the limited data set obtained from our sample of completed subjects, and (3) to discuss the problems that were encountered in conducting this study. METHODS: A randomized clinical trial was conducted with a factorial design in which adult TTH sufferers with more than 10 headaches per month were randomly assigned to four groups: real cervical manipulation + real amitriptyline, real cervical manipulation + placebo amitriptyline, sham cervical manipulation + real amitriptyline, and sham cervical manipulation + placebo amitriptyline. A baseline period of four weeks was followed by a treatment period of 14 weeks. The primary outcome was headache frequency obtained from a headache diary in the last 28 days of the treatment period. RESULTS: Nineteen subjects completed the trial. In the unadjusted analysis, a statistically significant main effect of chiropractic treatment was obtained (-2.2 [-10.2 to 5.8], P = .03) which was just below the 3-day reduction set for clinical importance. As well, a clinically important [corrected] effect of the combined therapies was obtained (-9 [-20.8 [corrected] to 2.9], P = .13), but this did not achieve statistical significance. In the adjusted analysis, neither the main effects of chiropractic nor amitriptyline were statistically significant or clinically important; however, the effect of the combined treatments was -8.4 (-15.8 to -1.1) which was statistically significant (P = .03) and reached our criterion for clinical importance. CONCLUSION: Although the sample size was smaller than initially required, a statistically significant and clinically important effect was obtained for the combined treatment group. There are considerable difficulties with recruitment of subjects in such a trial. This trial should be replicated with a larger sample.

Safety of chiropractic interventions: a systematic review.

STUDY DESIGN: Systematic review of reported adverse events. OBJECTIVE: To evaluate the tolerability and safety of chiropractic procedures. SUMMARY OF BACKGROUND DATA: Despite the increasing popularity of chiropractic, there are few properly designed prospective controlled trials, and there is a disproportionate lack of evaluation of its safety profile. The literature reports multiple neurologic complications of spinal manipulation, some of which are clinically relevant and even life threatening. METHODS: We performed an electronic search in 2 databases: Pubmed and the Cochrane Library for the years 1966 to 2007. All articles that reported adverse reactions associated with chiropractic were included irrespective of type of design. The outcome measures were the type of adverse events associated or attributed to chiropractic interventions and their frequency. RESULTS: A total of 376 potential relevant articles were identified, 330 of which were discarded after abstract or complete article analysis. The search identified 46 articles that included data concerning adverse events: 1 randomized controlled trial, 2 case-control studies, 7 prospective studies, 12 surveys, 3 retrospective studies, and 115 case reports. Most of the adverse events reported were benign and transitory, however, there are reports of complications that were life threatening, such as arterial dissection, myelopathy, vertebral disc extrusion, and epidural hematoma. The frequency of adverse events varied between 33% and 60.9%, and the frequency of serious adverse events varied between 5 strokes/100,000 manipulations to 1.46 serious adverse events/10,000,000 manipulations and 2.68 deaths/10,000,000 manipulations. CONCLUSION: There is no robust data concerning the incidence or prevalence of adverse reactions after chiropractic. Further investigations are urgently needed to assess definite conclusions regarding this issue.

Chiropractic: a critical evaluation.

Chiropractic was defined by D.D. Palmer as "a science of healing without drugs." About 60,000 chiropractors currently practice in North America, and, worldwide, billions are spent each year for their services. This article attempts to critically evaluate chiropractic. The specific topics include the history of chiropractic; the internal conflicts within the profession; the concepts of chiropractic, particularly those of subluxation and spinal manipulation; chiropractic practice and research; and the efficacy, safety, and cost of chiropractic. A narrative review of selected articles from the published chiropractic literature was performed. For the assessment of efficacy, safety, and cost, the evaluation relied on previously published systematic reviews. Chiropractic is rooted in mystical concepts. This led to an internal conflict within the chiropractic profession, which continues today. Currently, there are two types of chiropractors: those religiously adhering to the gospel of its founding fathers and those open to change. The core concepts of chiropractic, subluxation and spinal manipulation, are not based on sound science. Back and neck pain are the domains of chiropractic but many chiropractors treat conditions other than musculoskeletal problems. With the possible exception of back pain, chiropractic spinal manipulation has not been shown to be effective for any medical condition. Manipulation is associated with frequent mild adverse effects and with serious complications of unknown incidence. Its cost-effectiveness has not been demonstrated beyond reasonable doubt. The concepts of chiropractic are not based on solid science and its therapeutic value has not been demonstrated beyond reasonable doubt.

Vertebral artery dissections after chiropractic neck manipulation in Germany over three years.

Vertebral artery dissection (VAD) has been observed in association with chirotherapy of the neck. However, most publications describe only single case reports or a small number of cases. We analyzed data from neurological departments at university hospitals in Germany over a three year period of time of subjects with vertebral artery dissections associated with chiropractic neck manipulation. We conducted a country-wide survey at neurological departments of all medical schools to identify patients with VAD after chirotherapy followed by a standardized questionnaire for each patient. 36 patients (mean age 40 + 11 years) with VAD were identified in 13 neurological departments. Clinical symptoms consistent with VAD started in 55% of patients within 12 hours after neck manipulation. Diagnosis of VAD was established in most cases using digital subtraction angiography (DSA), magnetic resonance angiography (MRA) or duplex sonography. 90% of patients admitted to hospital showed focal neurological deficits and among these 11 % had a reduced level of consciousness. 50% of subjects were discharged after 20 +/- 14 hospital days with focal neurological deficits, 1 patient died and 1 was in a persistent vegetative state. Risk factors associated with artery dissections (e. g. fibromuscular dysplasia) were present in only 25% of subjects. In summary, we describe the clinical pattern of 36 patients with vertebral artery dissections and prior chiropractic neck manipulation.

Serious adverse effects of unconventional therapies for children and adolescents: a systematic review of recent evidence.

Unconventional therapies have become popular in paediatric and adolescent populations. It is therefore important to define their risks. The aim of this systematic review was to summarise the recent evidence. Computerised literature searches were carried out in five databases to identify all recent reports of adverse events associated with unconventional therapies in children. The reports were summarised in narrative and tabular form. The results show that numerous case reports and several case series have been published since 1990. Investigations of a more systematic nature are, however, rare. Most of the adverse events were associated with herbal medications. Inadequately regulated herbal medicines may contain toxic plant material, be contaminated with heavy metals, or be adulterated with synthetic drugs. The adverse events included bradycardia, brain damage, cardiogenic shock, diabetic coma, encephalopathy, heart rupture, intravascular haemolysis, liver failure, respiratory failure, toxic hepatitis and death. A high degree of uncertainty regarding a causal relationship between therapy and adverse event was frequently noted. The size of the problem and its importance relative to the well-documented risks of conventional treatments are presently unknown. Several unconventional therapies may constitute a risk to the health of children and adolescents. At present, it is impossible to provide reliable incidence figures. It seems important to be vigilant and investigate this area more systematically.