Symptomatic reactions, clinical outcomes and patient satisfaction associated with upper cervical chiropractic care: A prospective, multicenter, cohort study

<p>Abstract</p> <p>Background</p> <p>Observational studies have previously shown that adverse events following manipulation to the neck and/or back are relatively common, although these reactions tend to be mild in intensity and self-limiting. However, no prospective study has examined the incidence of adverse reactions following spinal adjustments using upper cervical techniques, and the impact of this care on clinical outcomes.</p> <p>Methods</p> <p>Consecutive new patients from the offices of 83 chiropractors were recruited for this practice-based study. Clinical outcome measures included 1) Neck pain disability index (100-point scale), 2) Oswestry back pain index (100-point scale), 3) 11-point numerical rating scale (NRS) for neck, headache, midback, and low back pain, 4) treatment satisfaction, and 5) Symptomatic Reactions (SR). Data were collected at baseline, and after approximately 2 weeks of care. A patient reaching sub-clinical status for pain and disability was defined as a follow-up score <3 NRS and <10%, respectively. A SR is defined as a new complaint not present at baseline or a worsening of the presenting complaint by >30% based on an 11-point numeric rating scale occurring <24 hours after any upper cervical procedure.</p> <p>Results</p> <p>A total of 1,090 patients completed the study having 4,920 (4.5 per patient) office visits requiring 2,653 (2.4 per patient) upper cervical adjustments over 17 days. Three hundred thirty- eight (31.0%) patients had SRs meeting the accepted definition. Intense SR (NRS ≥8) occurred in 56 patients (5.1%). Outcome assessments were significantly improved for neck pain and disability, headache, mid-back pain, as well as lower back pain and disability (<it>p </it><0.001) following care with a high level (mean = 9.1/10) of patient satisfaction. The 83 chiropractors administered >5 million career upper cervical adjustments without a reported incidence of serious adverse event.</p> <p>Conclusions</p> <p>Upper cervical chiropractic care may have a fairly common occurrence of mild intensity SRs short in duration (<24 hours), and rarely severe in intensity; however, outcome assessments were significantly improved with less than 3 weeks of care with a high level of patient satisfaction. Although our findings need to be confirmed in subsequent randomized studies for definitive risk-benefit assessment, the preliminary data shows that the benefits of upper cervical chiropractic care may outweigh the potential risks.</p

Prevalence of pain-free weeks in chiropractic subjects with low back pain - a longitudinal study using data gathered with text messages

<p>Abstract</p> <p>Introduction</p> <p>The use of automated text messages has made it possible to identify different courses of low back pain (LBP), and it has been observed that pain often fluctuates and that absolute recovery is rather rare. The purpose of this study was to describe the prevalence of pain-free weeks and pain-free periods in subjects with non-specific LBP treated by chiropractors, and to compare subjects from two different countries in these aspects.</p> <p>Methods</p> <p>Data were obtained from two practice-based multicentre prospective outcome studies, one Danish and one Swedish, involving subjects being treated by chiropractors for non-specific LBP. Over 18 weeks, subjects answered a weekly automated text message question on the number of days in the past week that they had experienced bothersome LBP, i.e. a number between 0 and 7. The number of weeks in a row without any LBP at all ("zero weeks") as well as the maximum number of zero weeks in a row was determined for each individual. Comparisons were made between the two study samples. Estimates are presented as percentages with 95% confidence intervals.</p> <p>Results</p> <p>In the Danish and the Swedish populations respectively, 93/110 (85%) and 233/262 (89%) of the subjects were eligible for analysis. In both groups, zero weeks were rather rare and were most commonly (in 40% of the zero weeks) reported as a single isolated week. The prevalence of pain free periods, i.e. reporting a maximum of 0, 1 or 2, or 3-6 zero weeks in a row, were similar in the two populations (20-31%). Smaller percentages were reported for ≥ 7 zero weeks in a row. There were no significant differences between the two study groups.</p> <p>Conclusion</p> <p>It was uncommon that chiropractic subjects treated for non-specific LBP experienced an entire week without any LBP at all over 18 weeks. When this occurred, it was most commonly reported for brief periods only. Hence, recovery in the sense that patients become absolutely pain free is rare, even in a primary care population.</p

The Nordic back pain subpopulation program: predicting outcome among chiropractic patients in Finland

<p>Abstract</p> <p>Background</p> <p>In a previous Swedish study it was shown that it is possible to predict which chiropractic patients with persistent LBP will not report definite improvement early in the course of treatment, namely those with LBP for altogether at least 30 days in the past year, who had leg pain, and who did not report definite general improvement by the second treatment. The objectives of this study were to investigate if the predictive value of this set of variables could be reproduced among chiropractic patients in Finland, and if the model could be improved by adding some new potential predictor variables.</p> <p>Methods</p> <p>The study was a multi-centre prospective outcome study with internal control groups, carried out in private chiropractic practices in Finland. Chiropractors collected data at the 1st, 2^ndand 4^thvisits using standardized questionnaires on new patients with LBP and/or radiating leg pain. Status at base-line was identified in relation to pain and disability, at the 2^ndvisit in relation to disability, and "definitely better" at the 4^thvisit in relation to a global assessment. The Swedish questionnaire was used including three new questions on general health, pain in other parts of the spine, and body mass index.</p> <p>Results</p> <p>The Swedish model was reproduced in this study sample. An alternative model including leg pain (yes/no), improvement at 2^ndvisit (yes/no) and BMI (underweight/normal/overweight or obese) was also identified with similar predictive values. Common throughout the testing of various models was that improvement at the 2^ndvisit had an odds ratio of approximately 5. Additional analyses revealed a dose-response in that 84% of those patients who fulfilled none of these (bad) criteria were classified as "definitely better" at the 4^thvisit, vs. 75%, 60% and 34% of those who fulfilled 1, 2 or all 3 of the criteria, respectively.</p> <p>Conclusion</p> <p>When treating patients with LBP, at the first visits, the treatment strategy should be different for overweight/obese patients with leg pain as it should be for all patients who fail to improve by the 2^ndvisit. The number of predictors is also important.</p

Possible adverse events in children treated by manual therapy: a review

BACKGROUND: Pediatric manual therapy is controversial within the medical community particularly with respect to adverse events. Pediatric manual therapy (Ped MT) is commonly used by a number of professions such as chiropractors, osteopaths and naturopaths for a variety of treatments in children. Ped MT interventions range from advice, light touch, massage, through to mobilisation and high velocity spinal manipulation. However, current evidence related to adverse events associated with Ped MT is not well understood. OBJECTIVE: To update the clinical research literature from the 2007 report by Vohra, Johnston, Cramer and Humphreys on possible adverse events in children treated by spinal manipulation. METHODS: A review of the clinical research literature from June 2004 until January 2010 as reported in MEDLINE, PubMed and PubMed Central for adverse events specifically related to the treatment of pediatric cases by manual therapy. RESULTS: Only three new clinical studies, one systematic review with meta-analysis and one evidence report were identified. Two clinical studies reported on chiropractic care and one on osteopathic spinal manipulation in children. The systematic review investigated all studies of adverse events and manual therapy and was not specific for pediatric patients. The evidence review focused on effectiveness of spinal manipulation in a variety of musculoskeletal conditions. No serious or catastrophic adverse events were reported in the clinical studies or systematic review. However for adults, it has been estimated that between 0.003% and 0.13% of manual therapy treatments may result in a serious adverse event. Although mild to moderate adverse events are common in adults, an accurate estimate from high quality pediatric studies is currently not available. CONCLUSIONS: There is currently insufficient research evidence related to adverse events and manual therapy. However, clinical studies and systematic reviews from adult patients undergoing manual therapy, particularly spinal manipulation report that mild to moderate adverse events are common and self limiting. However serious adverse events are rare and much less than for medication commonly prescribed for these problems. More high quality research specifically addressing adverse events and pediatric manual therapy is needed

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