Assessment of chiropractic care on strength, balance, and endurance in active-duty U.S. military personnel with low back pain: a protocol for a randomized controlled trial.

BACKGROUND: Low back pain (LBP) is a common cause of disability among U.S. military personnel. Approximately 20% of all diagnoses resulting in disability discharges are linked to back-related conditions. Because LBP can negatively influence trunk muscle strength, balance, and endurance, the military readiness of active-duty military personnel with LBP is potentially compromised. Chiropractic care may facilitate the strengthening of trunk muscles, the alteration of sensory and motor signaling, and a reduction in pain sensitivity, which may contribute to improving strength, balance, and endurance for individuals with LBP. This trial will assess the effects of chiropractic care on strength, balance, and endurance for active-duty military personnel with LBP. METHODS/DESIGN: This randomized controlled trial will allocate 110 active-duty military service members aged 18-40 with non-surgical acute, subacute, or chronic LBP with pain severity of ≥2/10 within the past 24 h. All study procedures are conducted at a single military treatment facility within the continental United States. Participants are recruited through recruitment materials approved by the institutional review board, such as posters and flyers, as well as through provider referrals. Group assignment occurs through computer-generated random allocation to either the study intervention (chiropractic care) or the control group (waiting list) for a 4-week period. Chiropractic care consists primarily of spinal manipulation at a frequency and duration determined by a chiropractic practitioner. Strength, balance, and endurance outcomes are obtained at baseline and after 4 weeks. The primary outcome is a change between baseline and 4 weeks of peak isometric strength, which is measured by pulling on a bimanual handle in a semi-squat position. Secondary outcomes include balance time during a single-leg standing test and trunk muscle endurance with the Biering-Sorensen test. Patient-reported outcomes include pain severity, disability measured with the Roland Morris Disability Questionnaire, symptom bothersomeness, PROMIS-29, Fear Avoidance Beliefs Questionnaire, expectations of care, physical activity, and global improvement. DISCUSSION: This trial may help inform further research on biological mechanisms related to manual therapies employed by chiropractic practitioners. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02670148 Registered on 1 February 2016.

Risk of stroke after chiropractic spinal manipulation in medicare B beneficiaries aged 66 to 99 years with neck pain.

OBJECTIVE: The purpose of this study was to quantify risk of stroke after chiropractic spinal manipulation, as compared to evaluation by a primary care physician, for Medicare beneficiaries aged 66 to 99 years with neck pain. METHODS: This is a retrospective cohort analysis of a 100% sample of annualized Medicare claims data on 1 157 475 beneficiaries aged 66 to 99 years with an office visit to either a chiropractor or primary care physician for neck pain. We compared hazard of vertebrobasilar stroke and any stroke at 7 and 30 days after office visit using a Cox proportional hazards model. We used direct adjusted survival curves to estimate cumulative probability of stroke up to 30 days for the 2 cohorts. RESULTS: The proportion of subjects with stroke of any type in the chiropractic cohort was 1.2 per 1000 at 7 days and 5.1 per 1000 at 30 days. In the primary care cohort, the proportion of subjects with stroke of any type was 1.4 per 1000 at 7 days and 2.8 per 1000 at 30 days. In the chiropractic cohort, the adjusted risk of stroke was significantly lower at 7 days as compared to the primary care cohort (hazard ratio, 0.39; 95% confidence interval, 0.33-0.45), but at 30 days, a slight elevation in risk was observed for the chiropractic cohort (hazard ratio, 1.10; 95% confidence interval, 1.01-1.19). CONCLUSIONS: Among Medicare B beneficiaries aged 66 to 99 years with neck pain, incidence of vertebrobasilar stroke was extremely low. Small differences in risk between patients who saw a chiropractor and those who saw a primary care physician are probably not clinically significant.

Risk of traumatic injury associated with chiropractic spinal manipulation in Medicare Part B beneficiaries aged 66 to 99 years.

STUDY DESIGN: Retrospective cohort study. OBJECTIVE: In older adults with a neuromusculoskeletal complaint, to evaluate risk of injury to the head, neck, or trunk after an office visit for chiropractic spinal manipulation compared with office visit for evaluation by primary care physician. SUMMARY OF BACKGROUND DATA: The risk of physical injury due to spinal manipulation has not been rigorously evaluated for older adults, a population particularly vulnerable to traumatic injury in general. METHODS: We analyzed Medicare administrative data on Medicare B beneficiaries aged 66 to 99 years with an office visit in 2007 for a neuromusculoskeletal complaint. Using a Cox proportional hazards model, we evaluated for adjusted risk of injury within 7 days, comparing 2 cohorts: those treated by chiropractic spinal manipulation versus those evaluated by a primary care physician. We used direct adjusted survival curves to estimate the cumulative probability of injury. In the chiropractic cohort only, we used logistic regression to evaluate the effect of specific chronic conditions on likelihood of injury. RESULTS: The adjusted risk of injury in the chiropractic cohort was lower than that of the primary care cohort (hazard ratio, 0.24; 95% confidence interval, 0.23-0.25). The cumulative probability of injury in the chiropractic cohort was 40 injury incidents per 100,000 subjects compared with 153 incidents per 100,000 subjects in the primary care cohort. Among subjects who saw a chiropractic physician, the likelihood of injury was increased in those with a chronic coagulation defect, inflammatory spondylopathy, osteoporosis, aortic aneurysm and dissection, or long-term use of anticoagulant therapy. CONCLUSION: Among Medicare beneficiaries aged 66 to 99 years with an office visit risk for a neuromusculoskeletal problem, risk of injury to the head, neck, or trunk within 7 days was 76% lower among subjects with a chiropractic office visit than among those who saw a primary care physician. LEVEL OF EVIDENCE: 3.

Informed consent for chiropractic care: Comparing patients' perceptions to the legal perspective.

PURPOSE: This study explored chiropractic patients' perceptions of exchanging risk information during informed consent and compared them with the legal perspective of the informed consent process. METHODS: Interviews were conducted with 26 participants, recruited from chiropractic clinics. Transcripts were analysed using a constant comparative method of analysis. FINDINGS: Participants experienced informed consent as an on-going process where risk information informed their decisions to receive treatment throughout four distinct stages. In the first stage, information acquired prior to arriving at the clinic for treatment shaped perceptions of risk. In stage two, participants assessed the perceived competence of their practitioners. Participants then signed the consent form and discussed the risks with their practitioners. Finally, they communicated with their practitioners during treatment to ensure their pain threshold was not crossed. CONCLUSION: These findings suggest that chiropractic patients perceive informed consent as a process involving communication with their practitioners, and that it is possible to educate patients about the risks associated with treatment while satisfying the legal requirements of informed consent.

Predictors of adverse events following chiropractic care for patients with neck pain.

OBJECTIVE: This study examines which variables may predict adverse events in subjects undergoing chiropractic treatment for neck pain. METHODS: This was a prospective, multi-center, cohort study. All new patients, 18 to 65 years of age with neck pain of any duration, who had not undergone chiropractic care or manual therapy in the prior 3 months, were eligible. Sources of data were questionnaires administered during the first 3 treatments. In all, 60 putative prognostic variables were examined, including descriptors of the patient, chiropractor, and type of treatment delivered. Adverse events were defined as either a new complaint, or the worsening of an existing complaint by more than 30% on an 11-point numerical rating scale. Multivariate random coefficients logistic regression analyses were conducted to determine predictors for the following outcome variables: (1) any adverse event after any of the first 3 visits, (2) any type of adverse event after the first visit only, and (3) specific types of adverse events after the first visit only (ie, headache, increased neck pain, pain and/or stiffness at the treated area). RESULTS: In total, 579 patients were recruited, of whom 529 fulfilled the inclusion criteria. The reported use of a manipulative technique involving cervical rotation, and working status of the patient (sick leave or workers' compensation) were moderately associated with an adverse event after any of the first 3 visits. Patients who had visited their general practitioner in the 6 months before treatment, however, were less likely to have an adverse event. A longer duration with neck pain in the preceding year was moderately associated with specific types of events after the first visit, namely, headache or worsening of the presenting neck pain. Increased neck pain after the first visit was the easiest outcome variable to predict (area under the curve, 0.88; 95% confidence interval, 0.84-0.91). CONCLUSIONS: Of the 60 independent variables examined, only 4 were found to be predictive of adverse events after chiropractic treatment for neck pain, one of which was found to be protective. The chiropractic practitioner can identify 3 of these variables before initiating treatment.

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.

Addition of choice of complementary therapies to usual care for acute low back pain: a randomized controlled trial.

STUDY DESIGN: A randomized controlled trial. OBJECTIVE: To investigate the effectiveness and cost of usual care plus patient choice of acupuncture, chiropractic, or massage therapy (choice) compared with usual care alone in patients with acute low back pain (LBP). SUMMARY OF BACKGROUND DATA: Few studies have evaluated care models with facilitated access to and financial coverage for adjunctive complementary and alternative medicine therapies. METHODS: A total of 444 patients with acute LBP (<21 days) were recruited from 4 clinical sites and randomized into 2 groups: usual care or choice. Outcomes included symptoms (bothersomeness), functional status (Roland), and satisfaction between baseline and 5 weeks, and cost of medical care in the 12 weeks after randomization. RESULTS: After 5 weeks, providing patients with a choice did not yield clinically important reductions in symptoms (median -4, [interquartile range -7, -2] for usual care, and -5 [-7, -3] for choice; P = 0.002) or improvements in functional status (-8 [-13, -2] for usual care, and -9 [-15, -4] for choice; P = 0.15). Although there was a significantly greater satisfaction with care in the choice group, this came at a net increase in costs of 244 dollars per patient. This consisted of a 99 dollars reduction in the average cost to the insurer for medical care but an additional cost of 343 dollars, for an average of 6.0 complementary and alternative medicine treatments per patient. CONCLUSIONS: A model of care that offered access to a choice of complementary and alternative medicine therapies for acute LBP did not result in clinically significant improvements in symptom relief or functional restoration. This model was associated with greater patient satisfaction but increased total costs. Future evaluations of this choice model should focus on patients with chronic conditions (including chronic back pain) for which conventional medical care is often costly and of limited benefit.

Safety of spinal manipulation in the treatment of lumbar disk herniations: a systematic review and risk assessment.

OBJECTIVE: To provide a qualitative systematic review of the risk of spinal manipulation in the treatment of lumbar disk herniations (LDH) and to estimate the risk of spinal manipulation causing a severe adverse reaction in a patient presenting with LDH. DATA SOURCES: Relevant case reports, review articles, surveys, and investigations regarding treatment of lumbar disk herniations with spinal manipulation and adverse effects and associated risks were found with a search of the literature. DATA SYNTHESIS: Prospective/retrospective studies and review papers were graded according to quality, and results and conclusions were tabulated. From the data published, an estimate of the risk of spinal manipulation causing a clinically worsened disk herniation or cauda equina syndrome (CES) in patients presenting with LDH was calculated. This was compared with estimates of the safety of nonsteroidal anti-inflammatory drugs (NSAIDs) and surgery in the treatment of LDH. RESULTS: An estimate of the risk of spinal manipulation causing a clinically worsened disk herniation or CES in a patient presenting with LDH is calculated from published data to be less than 1 in 3.7 million. CONCLUSION: The apparent safety of spinal manipulation, especially when compared with other "medically accepted" treatments for LDH, should stimulate its use in the conservative treatment plan of LDH.

[Cervical spine manipulation: risks--benefit--assessment]. / Manipulations du rachis cervical: risques--bénéfices--précautions.

Cervical manipulation is a widely used method indicated in non-specific mechanical neck pain and cervicogenic headache. Cervical manipulation can cause severe neurologic complications which are both rare and generally unpredictable, which can be compared with the accidents occurring with other treatments (nonsteroidal anti-inflammatory drugs...). To decrease this risk, we propose five recommendations developed by consensus: --unwanted effects, however minor (e.g. nausea or vertigo), of prior manipulation should be searched for routinely and taken as contraindications for future spinal manipulations; --a thorough physical examination, including a neurological evaluation should be performed prior to manipulation; --all know indications and contraindications should be followed; -- manipulations should be performed only by physicians experienced in this technique; --special caution should be exercised when performing first-line cervical manipulation and simple, honest and easily understandable information about these risks should be included when informed consent is obtained.

Chiropractic.

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.