Chiropractic for Hypertension in Patients
- Conditions
- Hypertension
- Interventions
- Other: Sham Spinal ManipulationOther: Spinal Manipulation
- Registration Number
- NCT01020435
- Lead Sponsor
- Palmer College of Chiropractic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 51
- Age > 21 and < 75
- Documented Stage I Hypertension
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Sham Spinal Manipulation Sham Spinal Manipulation The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al. Spinal Manipulation High Velocity Spinal Manipulation This non-rotary upper cervical procedure uses an impulse thrust with a controlled depth (high velocity). The participant's head is supported by a specially designed cushion and the doctor usually approaches the participant from in front of his or her head to contact soft tissue over the atlas transverse process, posterior to the lateral mass or occasionally on the C2 lamina or spinous process, with the pisiform process of one hand. The thrust is delivered by a contraction of the triceps muscles of both arms, which straightens the arms and applies the thrust to the participant.
- Primary Outcome Measures
Name Time Method Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 Baseline after 1, 3, and 6 Weeks of treatment 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Palmer College of Chirpractic
🇺🇸Davenport, Iowa, United States