Chiropractic for Hypertension in Patients

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.

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<140 or >159mm Hg (AND) Avg DBP<90 or >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