Chiropractic for Hypertension in Patients

NCT01020435 | Completed Results DMC

• 1 other identifier: CHiP
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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).

Conditions

Hypertension

Keywords

Hypertension

Outcome Measures

Primary Outcomes (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).

  Baseline after 1, 3, and 6 Weeks of treatment

Other Outcomes (2)

• Number of Participants Who Were Recruited, Consented, Enrolled/Randomized, and Retained for the Duration of the Study

  19 months

• Study Duration From Launch Date to Final Outcomes

  19 months

Study Arms (2)

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.

Other: Spinal Manipulation

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.

Other: Sham Spinal Manipulation

Interventions

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).

Spinal Manipulation High Velocity

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.

Also known as: Sham

Sham Spinal Manipulation

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Palmer College of Chiropractic: lead

Study Sites (1)

Palmer College of Chirpractic

Davenport, Iowa, 52803, United States

Location

Related Publications (4)

• 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.

  PMID: 26136608 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.

  PMID: 27745887 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.

  PMID: 27742418 BACKGROUND

• 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.

  PMID: 27157678 RESULT

Related Links

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

MeSH Terms

Conditions

Hypertension

Interventions

Manipulation, Spinal; salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Musculoskeletal Manipulations; Physical Therapy Modalities; Therapeutics; Rehabilitation

Results Point of Contact

• Title: Christine M Goertz, DC, PhD (Study Principal Investigator)
• Organization: Palmer College of Chiropractic

christine.goertz@palmer.edu

563-884-5150

Study Officials

• Christine M Goertz, DC, PhD

  Palmer College of Chiropractic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 24, 2009
• First Posted: November 25, 2009
• Study Start: October 1, 2010
• Primary Completion: April 1, 2012
• Study Completion: May 1, 2012
• Last Updated: February 7, 2018
• Results First Posted: February 7, 2018

Record last verified: 2018-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)