Chiropractic for Hypertension in Patients

N/ACompletedNCT01020435

Palmer College of Chiropractic51 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Hypertension

Interventions

Spinal ManipulationOTHER

The procedure in its broadest definition describes the application of a load (force or displacement) to specific body tissues (usually vertebral joints) with therapeutic intent. The mechanical characteristics of SM can vary in terms of its duration and amplitude, (hence, the rate at which it is applied), as well as its anatomical location, choice of levers, direction of force application, and the vehicle used to apply the force (manually or mechanically assisted).

Sham Spinal ManipulationOTHER

The sham assessment procedures will be the same as those in the high velocity treatment group. The sham intervention is identical to this treatment protocol except for the placement of the treating clinicians pisiform contact. The force and vector applied will be the same.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 75 Years

Medical Language ↔ Plain English

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

Locations (1)

Palmer College of Chirpractic

Davenport, Iowa, United States

Outcomes

Primary Outcomes

Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6

To estimate the effect size and variability of change in systolic (SBP) and/or diastolic blood pressure (DBP) 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. The table shows the unadjusted and adjusted mean change in SBP and DBP from baseline to after Treatment 1 (Tx 1), 3 (Wk 3), and 6 (Wk 6) Weeks. Adjusted values were adjusted for age, sex, BMI, and respective baseline blood pressure. Wk 3 and Wk 6 DBP were also adjusted for stage of blood pressure (prehypertension or Stage 1 hypertension).

Time frame: Baseline after 1, 3, and 6 Weeks of treatment

Data from ClinicalTrials.gov

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