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

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          Abstract

          Background

          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.

          Methods

          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.

          Results

          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 ( p <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.

          Conclusions

          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.

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          Most cited references46

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          Risk of vertebrobasilar stroke and chiropractic care: results of a population-based case-control and case-crossover study.

          Population-based, case-control and case-crossover study. To investigate associations between chiropractic visits and vertebrobasilar artery (VBA) stroke and to contrast this with primary care physician (PCP) visits and VBA stroke. Chiropractic care is popular for neck pain and headache, but may increase the risk for VBA dissection and stroke. Neck pain and headache are common symptoms of VBA dissection, which commonly precedes VBA stroke. Cases included eligible incident VBA strokes admitted to Ontario hospitals from April 1, 1993 to March 31, 2002. Four controls were age and gender matched to each case. Case and control exposures to chiropractors and PCPs were determined from health billing records in the year before the stroke date. In the case-crossover analysis, cases acted as their own controls. There were 818 VBA strokes hospitalized in a population of more than 100 million person-years. In those aged <45 years, cases were about three times more likely to see a chiropractor or a PCP before their stroke than controls. Results were similar in the case control and case crossover analyses. There was no increased association between chiropractic visits and VBA stroke in those older than 45 years. Positive associations were found between PCP visits and VBA stroke in all age groups. Practitioner visits billed for headache and neck complaints were highly associated with subsequent VBA stroke. VBA stroke is a very rare event in the population. The increased risks of VBA stroke associated with chiropractic and PCP visits is likely due to patients with headache and neck pain from VBA dissection seeking care before their stroke. We found no evidence of excess risk of VBA stroke associated chiropractic care compared to primary care.
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            A randomized clinical trial of exercise and spinal manipulation for patients with chronic neck pain.

            A randomized, parallel-group, single-blinded clinical trial was performed. After a 1-week baseline period, patients were randomized to 11 weeks of therapy, with posttreatment follow-up assessment 3, 6, and 12 months later. To compare the relative efficacy of rehabilitative neck exercise and spinal manipulation for the management of patients with chronic neck pain. Mechanical neck pain is a common condition associated with substantial morbidity and cost. Relatively little is known about the efficacy of spinal manipulation and exercise for chronic neck pain. Also, the combination of both therapies has yet to be explored. Altogether, 191 patients with chronic mechanical neck pain were randomized to receive 20 sessions of spinal manipulation combined with rehabilitative neck exercise (spinal manipulation with exercise), MedX rehabilitative neck exercise, or spinal manipulation alone. The main outcome measures were patient-rated neck pain, neck disability, functional health status (as measured by Short Form-36 [SF-36]), global improvement, satisfaction with care, and medication use. Range of motion, muscle strength, and muscle endurance were assessed by examiners blinded to patients' treatment assignment. Clinical and demographic characteristics were similar among groups at baseline. A total of 93% of the patients completed the intervention phase. The response rate for the 12-month follow-up period was 84%. Except for patient satisfaction, where spinal manipulative therapy and exercise were superior to spinal manipulation with (P = 0.03), the group differences in patient-rated outcomes after 11 weeks of treatment were not statistically significant (P = 0.13). However, the spinal manipulative therapy and exercise group showed greater gains in all measures of strength, endurance, and range of motion than the spinal manipulation group (P < 0.05). The spinal manipulation with exercise group also demonstrated more improvement in flexion endurance and in flexion and rotation strength than the MedX group (P < 0.03). The MedX exercise group had larger gains in extension strength and flexion-extension range of motion than the spinal manipulation group (P < 0.05). During the follow-up year, a greater improvement in patient-rated outcomes were observed for spinal manipulation with exercise and for MedX exercise than for spinal manipulation alone (P = 0.01). Both exercise groups showed very similar levels of improvement in patient-rated outcomes, although the spinal manipulation and exercise group reported greater satisfaction with care (P < 0.01). For chronic neck pain, the use of strengthening exercise, whether in combination with spinal manipulation or in the form of a high-technology MedX program, appears to be more beneficial to patients with chronic neck pain than the use of spinal manipulation alone. The effect of low-technology exercise or spinal manipulative therapy alone, as compared with no treatment or placebo, and the optimal dose and relative cost effectiveness of these therapies, need to be evaluated in future studies.
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              Adverse events associated with pediatric spinal manipulation: a systematic review.

              Spinal manipulation is a noninvasive manual procedure applied to specific body tissues with therapeutic intent. Although spinal manipulation is commonly used in children, there is limited understanding of the pediatric risk estimates. Our goal was to systematically identify and synthesize available data on adverse events associated with pediatric spinal manipulation. A comprehensive search was performed of 8 major electronic databases (eg, Medline, AMED, MANTIS) from inception to June 2004 irrespective of language. Reports were included if they (1) were a primary investigation of spinal manipulation (eg, observation studies, controlled trials, surveys), (2) included a study population of children who were aged 18 years or younger, and (3) reported data on adverse events. Data were summarized to demonstrate the nature and severity of adverse events that may result rather than their incidence. Thirteen studies (2 randomized trials, 11 observational reports) were identified for inclusion. We identified 14 cases of direct adverse events involving neurologic or musculoskeletal events. Nine cases involved serious adverse events (eg, subarachnoidal hemorrhage, paraplegia), 2 involved moderately adverse events that required medical attention (eg, severe headache), and 3 involved minor adverse events (eg, midback soreness). Another 20 cases of indirect adverse events involved delayed diagnosis (eg, diabetes, neuroblastoma) and/or inappropriate provision of spinal manipulation for serious medical conditions (ie, meningitis, rhabdomyosarcoma). Serious adverse events may be associated with pediatric spinal manipulation; neither causation nor incidence rates can be inferred from observational data. Conduct of a prospective population-based active surveillance study is required to properly assess the possibility of rare, yet serious, adverse events as a result of spinal manipulation on pediatric patients.
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                Author and article information

                Journal
                BMC Musculoskelet Disord
                BMC Musculoskeletal Disorders
                BioMed Central
                1471-2474
                2011
                5 October 2011
                : 12
                : 219
                Affiliations
                [1 ]Chiropractic Health Institute, PC, Clinic Director, 2500 Flowers Chapel Road, Dothan, AL 36305, USA
                [2 ]Chiropractic Spine Center of North Georgia, Inc., Clinic Director, 475 S. Washington, Street, Suite C, Clarkesville, GA 30523, USA
                [3 ]John A. Burns School of Medicine, Department of Public Health Sciences, University of Hawaii, Mānoa, Honolulu, Hawaii 96822, USA
                Article
                1471-2474-12-219
                10.1186/1471-2474-12-219
                3204272
                21974915
                ceb18890-58a7-4f68-a193-9cf1e09a0fd6
                Copyright ©2011 Eriksen et al; licensee BioMed Central Ltd.

                This is an Open Access article distributed under the terms of the Creative Commons Attribution License ( http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                : 27 July 2011
                : 5 October 2011
                Categories
                Research Article

                Orthopedics
                chiropractic,symptomatic reactions,manipulation,upper cervical,adverse effects
                Orthopedics
                chiropractic, symptomatic reactions, manipulation, upper cervical, adverse effects

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