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Chiropractic for Hypertension in Patients (CHiP)

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ClinicalTrials.gov Identifier: NCT01020435
Recruitment Status : Completed
First Posted : November 25, 2009
Results First Posted : February 7, 2018
Last Update Posted : February 7, 2018
Sponsor:
Information provided by (Responsible Party):
Palmer College of Chiropractic

November 24, 2009
November 25, 2009
April 18, 2017
February 7, 2018
February 7, 2018
October 2010
April 2012   (Final data collection date for primary outcome measure)
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).

The primary aim is to determine the efficacy of non-rotary upper cervical SM in lowering Systolic Blood Pressure when compared to a sham control group. [ Time Frame: 4 weeks, 8 weeks, 12 weeks, and 6 months ]
Complete list of historical versions of study NCT01020435 on ClinicalTrials.gov Archive Site
Not Provided
  • To determine if patients receiving the low-velocity, non-rotary upper cervical procedure have a different BP outcome when compared to those receiving the high-velocity non-rotary upper cervical procedure. [ Time Frame: 4 weeks, 8 weeks, 12 weeks and 6 months ]
  • To establish a reliable method of measuring the atlas alignment using plain film x-ray. [ Time Frame: 8 weeks ]
  • To explore the relationship between atlas alignment change, as measured by x-ray, and blood pressure change [ Time Frame: 4 weeks, 8 weeks, 12 weeks and 6 months ]
  • To determine the durability of Systolic and Diastolic Blood Pressure reduction in the active treatment group(s) across the 6-month follow up period. [ Time Frame: 6 months ]
  • 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.
  • 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.
Not Provided
 
Chiropractic for Hypertension in Patients
Upper Cervical Manipulation for Patients With Stage 1 Hypertension
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.
Interventional
Not Applicable
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Hypertension
  • 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).
  • 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
  • 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.
    Intervention: Other: Spinal Manipulation
  • 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.
    Intervention: Other: Sham Spinal Manipulation

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
51
165
May 2012
April 2012   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
21 Years to 75 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01020435
CHiP
Yes
Not Provided
Plan to Share IPD: No
Plan Description: Feasibility/pilot study
Palmer College of Chiropractic
Palmer College of Chiropractic
Not Provided
Principal Investigator: Christine M Goertz, DC, PhD Palmer College of Chiropractic
Palmer College of Chiropractic
January 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP