Chiropractic for Hypertension in Patients (CHiP)

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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).

Condition or disease	Intervention/treatment	Phase
Hypertension	Other: Spinal Manipulation; Other: Sham Spinal Manipulation	Not Applicable

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Outcomes Assessor)
Primary Purpose:	Treatment
Official Title:	Upper Cervical Manipulation for Patients With Stage 1 Hypertension
Study Start Date :	October 2010
Actual Primary Completion Date :	April 2012
Actual Study Completion Date :	May 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Active Comparator: 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 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.	Other: Spinal 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).
Placebo Comparator: Sham Spinal Manipulation; The sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.	Other: 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.; Other Name: Sham

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. Unadjusted and Adjusted Changes From Baseline in Systolic and Diastolic Blood Pressure at Weeks 1, 3, 6 [ Time Frame: 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 Outcome Measures:

1. Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study [ Time Frame: 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.
2. Study Duration From Launch Date to Final Outcomes [ Time Frame: 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.

Eligibility Criteria

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Ages Eligible for Study:	21 Years to 75 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Iowa
Palmer College of Chirpractic
Davenport, Iowa, United States, 52803

Sponsors and Collaborators

Palmer College of Chiropractic

Investigators

Principal Investigator:	Christine M Goertz, DC, PhD	Palmer College of Chiropractic

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:

Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial 

Inter-examiner reliability of the interpretation of paraspinal thermographic pattern analysis 

Letters to the Editor: Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial 

Response to Letter to the Editor on &quot;Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial&quot; 

Publications of Results:

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):369-80. doi: 10.1016/j.jmpt.2016.04.002. Epub 2016 May 9.

Other Publications:

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.

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.

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.

Responsible Party:	Palmer College of Chiropractic
ClinicalTrials.gov Identifier:	NCT01020435 History of Changes
Obsolete Identifiers:	NCT01230372
Other Study ID Numbers:	CHiP
First Posted:	November 25, 2009
Results First Posted:	February 7, 2018
Last Update Posted:	February 7, 2018
Last Verified:	January 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No
Plan Description:	Feasibility/pilot study

Keywords provided by Palmer College of Chiropractic:

Hypertension

Additional relevant MeSH terms:

Hypertension; Vascular Diseases; Cardiovascular Diseases