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HypertensionCHiPNCT01020435

Chiropractic for Hypertension in Patients

A study testing Spinal Manipulation in people with Hypertension, run by Palmer College of Chiropractic at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 21 to 75 years
Conditions the study is for
Hypertension
What is being tested?
Spinal Manipulation
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
51 participants
Where
1 siteUnited States
Study dates
Oct 2010to May 2012
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Age > 21 and < 75
  • Documented Stage I Hypertension

Who cannot join

  • 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
Show all 30Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Palmer College of Chirpractic

    Davenport, Iowa, 52803

Other trials in United States

About this study

Official title: 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).

Read the 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.

Conditions
Hypertension
Being tested
Spinal Manipulation, Sham Spinal Manipulation
Keywords
Hypertension
Medical subject headings
Hypertension

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Spinal ManipulationOther

    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).

  • Sham Spinal ManipulationOther

    Also called Sham

    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.

Study groups in NCT01020435
Study groupRoleWhat they receive
Spinal Manipulation High VelocityActive comparatorThis 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.
Receives: Other: Spinal Manipulation
Sham Spinal ManipulationPlacebo comparatorThe sham assessment procedures will be similar to the active group. It has been developed and validated by Vernon et al.
Receives: Other: Sham Spinal Manipulation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: Baseline after 1, 3, and 6 Weeks of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Nov 2009 (estimated)
  2. Study startOct 2010
  3. Primary completionApr 2012
  4. Study completionMay 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01020435
Sponsor's protocol ID
CHiP
Acronym
CHiP
Status last verified
Jan 2018
First submitted
24 Nov 2009
Last updated
7 Feb 2018
Data monitoring committee
Yes
Individual data sharing
No: Feasibility/pilot study

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.

    PubMed 26136608

  • 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.

    PubMed 27745887

  • 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.

    PubMed 27742418

  • 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.

    PubMed 27157678

Questions about this trial

What is this clinical trial studying?

A study testing Spinal Manipulation in people with Hypertension, run by Palmer College of Chiropractic at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 30 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 7 Feb 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the 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). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01020435, which also lists 4 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Feb 2018.

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Chiropractic for Hypertension in Patients | AzTrials