Atlas vertebra realignment and achievement of arterial pressure goal in hypertensive patients: a pilot study

Department of Preventive Medicine, Rush University Hypertension Center, Chicago, IL, USA.
Journal of Human Hypertension (Impact Factor: 2.7). 06/2007; 21(5):347-52. DOI: 10.1038/sj.jhh.1002133
Source: PubMed


Anatomical abnormalities of the cervical spine at the level of the Atlas vertebra are associated with relative ischaemia of the brainstem circulation and increased blood pressure (BP). Manual correction of this mal-alignment has been associated with reduced arterial pressure. This pilot study tests the hypothesis that correcting mal-alignment of the Atlas vertebra reduces and maintains a lower BP. Using a double blind, placebo-controlled design at a single center, 50 drug naïve (n=26) or washed out (n=24) patients with Stage 1 hypertension were randomized to receive a National Upper Cervical Chiropractic (NUCCA) procedure or a sham procedure. Patients received no antihypertensive meds during the 8-week study duration. The primary end point was changed in systolic and diastolic BP comparing baseline and week 8, with a 90% power to detect an 8/5 mm Hg difference at week 8 over the placebo group. The study cohort had a mean age 52.7+/-9.6 years, consisted of 70% males. At week 8, there were differences in systolic BP (-17+/-9 mm Hg, NUCCA versus -3+/-11 mm Hg, placebo; P<0.0001) and diastolic BP (-10+/-11 mm Hg, NUCCA versus -2+/-7 mm Hg; P=0.002). Lateral displacement of Atlas vertebra (1.0, baseline versus 0.04 degrees week 8, NUCCA versus 0.6, baseline versus 0.5 degrees , placebo; P=0.002). Heart rate was not reduced in the NUCCA group (-0.3 beats per minute, NUCCA, versus 0.5 beats per minute, placebo). No adverse effects were recorded. We conclude that restoration of Atlas alignment is associated with marked and sustained reductions in BP similar to the use of two-drug combination therapy.

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    • "This data stimulates the question: "Is UCT a plausible type of care for lower back pain patients?" Two case series and one randomized clinical trial have demonstrated better outcomes for musculoskeletal symptoms and hypertension (without pain), respectively, for patients receiving reductions in C1 misalignment following UCT care relative to patients receiving smaller or no corrections in alignment [33,34,56]. Also, the present study reports fewer adjustments and a shorter follow-up period than previous chiropractic studies while demonstrating similar or better-improved outcome levels [52-55]. "
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    ABSTRACT: 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. 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. 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. 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.
    BMC Musculoskeletal Disorders 10/2011; 12(1):219. DOI:10.1186/1471-2474-12-219 · 1.72 Impact Factor
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    • "These studies reported that the blinding was generally successful. Two studies which did use a placebo control [32,33] did not report post-intervention registration. None of the studies which used non-placebo control groups reported on the degree to which subjects in each of their study groups could identify their group registration. "
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    ABSTRACT: To characterize the types of control procedures used in controlled clinical trials of cervical spine manipulation and to evaluate the outcomes obtained by subjects in control groups so as to improve the quality of future clinical trials A search of relevant clinical trials was performed in PubMed 1966-May 2010 with the following key words: "Chiropractic"[Mesh] OR "Manipulation, Spinal"[Mesh]) AND "Clinical Trial "[Publication Type]. Reference lists from these trials were searched for any additional trials. The reference lists of two prior studies, one review and one original study were also searched. Accepted reports were then rated for quality by 2 reviewers using the PEDro scale. Studies achieving a score of >50% were included for data extraction and analysis. Intra-group change scores on pain outcomes were obtained. For determining clinically important outcomes, a threshold of 20% improvement was used where continuous data were available; otherwise, an effect size of 0.30 was employed The PubMed search yielded 753 citations of which 13 were selected. Eight (8) other studies were identified by reviewing two systematic reviews and through reference searches. All studies scored >50% on the PEDro scale. There were 9 multi-session studies and 12 single-session studies. The most commonly used control procedure was "manual contact/no thrust". Four (4) studies used a placebo-control (patient blinded). For two of these studies with VAS data, the average change reported was 4.5 mm. For the other control procedures, variable results were obtained. No clinically important changes were reported in 57% of the paired comparisons, while, in 43% of these, changes which would be considered clinically important were obtained in the control groups. Only 15% of trials reported on post-intervention group registration. Most control procedures in cervical manipulation trials result in small clinical changes, although larger changes are observed in 47% of paired comparisons. The vast majority of studies do not result in subject blinding; the effect of unmasking of control subjects in these studies makes the interpretation of the existing clinical trials challenging. The greatest majority of trials do not report on post-intervention blinding. A small number of candidate procedures for effective control interventions exist. Much more research is required to improve this important aspect of clinical trial methodology in cervical manipulation studies.
    Chiropractic and Manual Therapies 01/2011; 19(1):3. DOI:10.1186/2045-709X-19-3
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