Chiropractic for Hypertension in Patients - Full Text View

Purpose

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	Intervention	Phase
Hypertension	Other: Spinal Manipulation Other: Sham Spinal Manipulation	Phase 2


Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Upper Cervical Manipulation for Patients With Stage 1 Hypertension

Resource links provided by NLM:

MedlinePlus related topics: Chiropractic

U.S. FDA Resources

Further study details as provided by Palmer College of Chiropractic:

Primary Outcome Measures:

Feasibility of conduction a full-scale randomized control trial to evaluate the efficacy of Toggle Recoil chiropractic manipulation for patients with stage 1 hypertension [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
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. We will assess: 1) the success of blinding clinic personnel to treatment allocation; 2) the ability to effectively use Academic Health Center faculty as research clinicians; 3) the ability to take blood pressure measurements according to protocol and keep clinic personnel blinded; 4) the ability to retain participants who are randomized to the placebo treatment (n=25) and the active treatment (n=25).

Secondary Outcome Measures:

Estimate the effect size and variability of change in systolic and/or diastolic blood pressure [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
To estimate the effect size and variability of change in systolic and/or diastolic blood pressure 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


Enrollment:	51
Study Start Date:	October 2010
Study Completion Date:	May 2012
Primary Completion Date:	April 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
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

Arms

Assigned Interventions

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

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.

Eligibility


Ages Eligible for Study:	21 Years to 75 Years (Adult, Senior)
Genders Eligible for Study:	Both
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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01020435

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

Additional Information:

Effect of Spinal Manipulation of Upper Cervical Vertebrae on Blood Pressure: Results of a Pilot Sham-Controlled Trial This link exits the ClinicalTrials.gov site

Inter-examiner reliability of the interpretation of paraspinal thermographic pattern analysis This link exits the ClinicalTrials.gov site

Publications:

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.

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.


Responsible Party:	Palmer College of Chiropractic
ClinicalTrials.gov Identifier:	NCT01020435 History of Changes
Obsolete Identifiers:	NCT01230372
Other Study ID Numbers:	CHiP
Study First Received:	November 24, 2009
Last Updated:	September 19, 2016
Health Authority:	United States: Institutional Review Board

Keywords provided by Palmer College of Chiropractic:


Hypertension

Additional relevant MeSH terms:


Hypertension Vascular Diseases Cardiovascular Diseases

ClinicalTrials.gov processed this record on September 26, 2016

Chiropractic for Hypertension in Patients (CHiP)