Chiropractic for Hypertension in Patients
| Status: | Completed |
|---|---|
| Conditions: | High Blood Pressure (Hypertension) |
| Therapuetic Areas: | Cardiology / Vascular Diseases |
| Healthy: | No |
| Age Range: | 21 - 75 |
| Updated: | 2/9/2018 |
| Start Date: | October 2010 |
| End Date: | May 2012 |
Upper Cervical Manipulation for Patients With Stage 1 Hypertension
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).
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.
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
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