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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Spinal Manipulation High Velocity | Active Comparator | 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. |
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| Sham Spinal Manipulation | Placebo Comparator | The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Spinal Manipulation | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | Baseline after 1, 3, and 6 Weeks of treatment |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christine M Goertz, DC, PhD | Palmer College of Chiropractic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Palmer College of Chirpractic | Davenport | Iowa | 52803 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26136608 | Background | 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. | |
| 27745887 | Background | 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. |
| Label | URL |
|---|---|
| Inter-examiner reliability of the interpretation of paraspinal thermographic pattern analysis | View source |
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Feasibility/pilot study
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Posted | Mean | 95% Confidence Interval | mmHg | Baseline after 1, 3, and 6 Weeks of treatment |
|
6 weeks
Any untoward medical occurrence that may present itself during the conduct of the study which may or may not have a causal relationship with the study procedures.
*The total number of AEs may exceed the total # of people affected because some people experienced multiple AEs.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Low back pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Christine M Goertz, DC, PhD (Study Principal Investigator) | Palmer College of Chiropractic | 563-884-5150 | christine.goertz@palmer.edu |
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| ID | Term |
|---|---|
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
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| ID | Term |
|---|---|
| D020393 | Manipulation, Spinal |
| C005703 | salicylhydroxamic acid |
| ID | Term |
|---|---|
| D026201 | Musculoskeletal Manipulations |
| D026741 | Physical Therapy Modalities |
| D013812 | Therapeutics |
| D012046 | Rehabilitation |
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| Sham Spinal Manipulation | Other | 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. |
|
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| 19 months |
| 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. | 19 months |
| 27742418 | Background | 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. |
| 27157678 | Result | 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. |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 | 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. |
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| 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. | 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. | Posted | Number | # participants | 19 months |
|
|
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| 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. | 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). | Posted | Number | months | 19 months |
|
|
|
| 0 |
| 24 |
| 0 |
| 24 |
| 6 |
| 24 |
| EG001 | 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. | 0 | 27 | 0 | 27 | 5 | 27 |
| Headache | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Migraine | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Headache and tenderness | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Neck and back pain and fracture | Musculoskeletal and connective tissue disorders | Systematic Assessment |
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| Radiating symptoms | General disorders | Systematic Assessment |
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| Dizziness/imbalance/vertigo | General disorders | Systematic Assessment |
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| Hypertension | General disorders | Systematic Assessment |
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| Hypotension | General disorders | Systematic Assessment |
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| Title | Measurements |
|---|---|
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| # Participants Enrolled/Randomized |
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| # Participants completed follow-up |
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