Chiropractic for Hypertension in Patients (CHiP)

• Feasibility of conduction a full-scale randomized control trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage 1 hypertension [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  To assess the feasibility of conducting a full-scale randomized controlled trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage I hypertension. We will assess: 1) the success of blinding clinic personnel to treatment allocation; 2) the ability to effectively use Academic Health Center faculty as research clinicians; 3) the ability to take blood pressure measurements according to protocol and keep clinic personnel blinded; 4) the ability to retain participants who are randomized to the placebo treatment (n=25) and the active treatment (n=25).
  
  

• Estimate the effect size and variability of change in systolic and/or diastolic blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
  To estimate the effect size and variability of change in systolic and/or diastolic blood pressure over a six week treatment period to use in planning a full-scale randomized controlled trial and to assess the believability of the placebo manipulation
  
  

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.