Hypertension
Conditions
Keywords
Hypertension
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.
Interventions
OTHERSpinal Manipulation
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).
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.
Sponsors
Palmer College of Chiropractic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
21 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study | 19 months | 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. Feasibility measured by: patient recruitment, enrollment, and retention, and duration of study from launch date to final outcomes. |
| Study Duration From Launch Date to Final Outcomes | 19 months | 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. Feasibility measured by and duration of study from launch date to final outcomes. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Spinal Manipulation High Velocity 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 the 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.
Spinal Manipulation is 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, 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). | 24 |
| Sham Spinal Manipulation The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.
Sham Spinal Manipulation: 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. | 27 |
| Total | 51 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Sham Spinal Manipulation | Total | Spinal Manipulation High Velocity |
|---|---|---|---|
| Age, Continuous | 54.9 years STANDARD_DEVIATION 12.1 | 56.2 years STANDARD_DEVIATION 10.6 | 57.6 years STANDARD_DEVIATION 8.5 |
| Race/Ethnicity, Customized Black | 5 Participants | 7 Participants | 2 Participants |
| Race/Ethnicity, Customized Other | 2 Participants | 2 Participants | 0 Participants |
| Race/Ethnicity, Customized White | 20 Participants | 42 Participants | 22 Participants |
| Sex: Female, Male Female | 12 Participants | 21 Participants | 9 Participants |
| Sex: Female, Male Male | 15 Participants | 30 Participants | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 24 | 0 / 27 |
| other Total, other adverse events | 6 / 24 | 5 / 27 |
| serious Total, serious adverse events | 0 / 24 | 0 / 27 |
Outcome results
Primary
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
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - SBP (Unadjusted) | -1.2 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - DBP (Unadjusted) | 0.8 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - SBP (Unadjusted) | -3.6 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - DBP (Unadjusted) | -2.4 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - SBP (Unadjusted) | -0.1 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - DBP (Unadjusted) | 0.3 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - SBP (Adjusted) | -0.9 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - DBP (Adjusted) | 1.4 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - SBP (Adjusted) | -3.0 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - DBP (Adjusted) | -1.8 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - SBP (Adjusted) | 0.6 mmHg |
| Spinal Manipulation High Velocity | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - DBP (Adjusted) | 0.7 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - SBP (Adjusted) | -4.2 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - SBP (Unadjusted) | -5.3 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - SBP (Adjusted) | -5.5 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - DBP (Unadjusted) | -1.7 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - DBP (Adjusted) | -2.8 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - SBP (Unadjusted) | -3.3 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Tx 1 - DBP (Adjusted) | -2.2 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - DBP (Unadjusted) | -2.2 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - DBP (Adjusted) | -1.6 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - SBP (Unadjusted) | -3.6 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 3 - SBP (Adjusted) | -3.9 mmHg |
| Sham Spinal Manipulation | Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 | Wk 6 - DBP (Unadjusted) | -1.2 mmHg |
Comparison: Tx 1 - SBP (Unadjusted)95% CI: [-0.9, 9.2]
Comparison: Tx 1 - DBP (Unadjusted)95% CI: [-0.4, 5.3]
Comparison: Wk 3 - SBP (Unadjusted)95% CI: [-6.2, 5.6]
Comparison: Wk 3 - DBP (Unadjusted)95% CI: [-4, 3.5]
Comparison: Wk 6 - SBP (Unadjusted)95% CI: [-1.9, 8.9]
Comparison: Wk 6 - DBP (Unadjusted)95% CI: [-2.1, 5]
Comparison: Tx 1 - SBP (Adjusted)95% CI: [-0.4, 9.8]
Comparison: Tx 1 - DBP (Adjusted)95% CI: [0.6, 6.5]
Comparison: Wk 3 - SBP (Adjusted)95% CI: [-5, 6.9]
Comparison: Wk 3 - DBP (Adjusted)95% CI: [-2.8, 4.9]
Comparison: Wk 6 - SBP (Adjusted)95% CI: [-0.4, 10]
Comparison: Wk 6 - DBP (Adjusted)95% CI: [-1.2, 5.8]
Other Pre-specified
Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study
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. Feasibility measured by: patient recruitment, enrollment, and retention, and duration of study from launch date to final outcomes.
Time frame: 19 months
Population: In this study, participants are not allocated to a treatment arm until they have met all eligibility criteria through the Final Case Review. Because of this it is not possible to report feasibility outcomes by treatment arm.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Spinal Manipulation High Velocity | Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study | # Participants screened via phone interview | 681 # participants |
| Spinal Manipulation High Velocity | Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study | # Participants consented at Baseline Visit 1 | 372 # participants |
| Spinal Manipulation High Velocity | Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study | # Participants eligible for final case review | 63 # participants |
| Spinal Manipulation High Velocity | Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study | # Participants Enrolled/Randomized | 51 # participants |
| Spinal Manipulation High Velocity | Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study | # Participants completed follow-up | 50 # participants |
Other Pre-specified
Study Duration From Launch Date to Final Outcomes
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. Feasibility measured by and duration of study from launch date to final outcomes.
Time frame: 19 months
Population: 51 participants were enrolled; however, the table below shows the number enrolled and consented before the 51 were enrolled. The final row of data shows, 19, signifying the study duration in MONTHS (October 2010 - April 2012).
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Spinal Manipulation High Velocity | Study Duration From Launch Date to Final Outcomes | 19 months |