Clinical trial NCT01020435: Chiropractic for Hypertension in Patients
Official title: Upper Cervical Manipulation for Patients With Stage 1 Hypertension
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypertension
Keywords: Hypertension
Lead sponsor: Palmer College of Chiropractic
Sponsor class: OTHER
First posted: 2009-11-25
Enrollment: 51
Sex: ALL
Minimum age (years): 21
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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).

Detailed description: 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\<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

Primary outcomes:
measure: Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6
timeFrame: Baseline after 1, 3, and 6 Weeks of treatment
Secondary outcomes:
Other outcomes:
measure: Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
timeFrame: 19 months
measure: Study Duration From Launch Date to Final Outcomes
timeFrame: 19 months
Locations:
city: Davenport
country: United States
facility: Palmer College of Chirpractic
state: Iowa
Study officials:
affiliation: Palmer College of Chiropractic
name: Christine M Goertz, DC, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansholt BA, Vining RD, Long CR, Goertz CM. Inter-examiner reliability of the interpretation of paraspinal thermographic pattern analysis. J Can Chiropr Assoc. 2015 Jun;59(2):157-64.
citation: Hart JF. Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial. J Manipulative Physiol Ther. 2016 Oct;39(8):603. doi: 10.1016/j.jmpt.2016.08.008. Epub 2016 Oct 13. No abstract available.
citation: Goertz CM, Salsbury SA, Vining RD. Response to Letter to the Editor on "Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial". J Manipulative Physiol Ther. 2016 Oct;39(8):603-604. doi: 10.1016/j.jmpt.2016.09.004. Epub 2016 Oct 11. No abstract available.
citation: Goertz CM, Salsbury SA, Vining RD, Long CR, Pohlman KA, Weeks WB, Lamas GA. Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial. J Manipulative Physiol Ther. 2016 Jun;39(5):369-380. doi: 10.1016/j.jmpt.2016.04.002. Epub 2016 May 9.