chiropractic for hypertension in patients

Conditions: Hypertension

Summary: the investigators propose a prospective randomized 2 arm parallel observer-blinded phase ii clinical study comparing a distinct method of upper cervical chiropractic manipulation to a sham technique in 50 individuals with stage i hypertension (systolic blood pressure (sbp): 140-159 mm hg; diastolic blood pressure (dbp):90-99 mm hg).

more than 50 million americans suffer from hypertension, a disease with far-reaching public health impact causing or contributing to 7.1 million deaths yearly at an estimated annual incremental direct cost of $54 billion per year. common treatments include antihypertensive medications and lifestyle modifications. while these treatments have been shown to be effective, only about 30% of hypertensive patients achieve blood pressure goals. based on a recently published study (bakris et al, 2007), one unique non-pharmaceutical approach may be a non-rotary type of upper cervical spinal manipulation to align the first cervical vertebra (atlas) performed by a doctor of chiropractic. we propose to conduct a similar study with a more commonly known chiropractic technique called toggle recoil. we propose a prospective randomized 2 arm parallel observer-blinded phase ii clinical study comparing a distinct method of upper cervical chiropractic manipulation to a sham technique in 50 (25 in each group) individuals with stage i hypertension (systolic blood pressure (sbp); 140-159 mm hg or diastolic blood pressure (dbp):90-99 mm hg). patients will be seen by doctors of chiropractic twice each week for 6 weeks and outcomes will be collected at baseline, 3 weeks, and 6 weeks after enrollment. the primary outcome measure will be change in sbp and the primary endpoint will be at the week 6 assessment.

Eligibility criteria:
inclusion criteria: * age \> 21 and \< 75 * documented stage i hypertension exclusion criteria: * cardiovascular disorders (angina pectoris, symptom of chd; hemodynamically significant valvular heart disease; second or third degree heart block without pacemaker; stroke, mi, cv surgery within the past 12 months; claudication, aortic coarctation) * defibrillator * autoimmune arthropathies * pregnancy * unwillingness to stop other forms of manual therapy during study * unwillingness to sign icd or preliminary consent * intention to move from the area during the next 4 months * unwillingness to participate in any of the treatment groups * avg sbp\ 159mm hg (and) avg dbp\ 99mm hg * any single sbp \> 160mm hg or dbp\> 100 * bmi \> 40 * prescription medications with increased risk for cva * current use of anti-coagulant medication/blood thinners * active drug or alcohol addiction or abstinent \< 1 year * psychiatric diagnosis that would limit patient compliance * serious concomitant medical illness * contraindication(s) to treatment * electrolyte abnormalities seen on lab test * renal failure w/ creatinine \>2.5mg/dl * abnormal liver function tests * anemia with hematocrit \< 30% * glucose in urine * serum potassium \<3.4 @ baseline * s/s renal artery stenosis * quebec task force classification 4-9 * self-reported arnold chiari malformation * spinal or paraspinal tumors * dx with disorder that exhibit spinal joint hypermobility (marfan syndrome, ehlers-danlos syndrome, osteogenesis imperfecta) * unstable endocrine disorders * osteoporosis

Keywords: hypertension