Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate

May 2, 2012 updated by: Dr. Steven D. Roffers, Spinal Missions, Inc., LLC

A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate

The purpose of this randomized controlled trial (RCT) is to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP) and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR. However, many of those studies have been criticized for various study flaws, and accused of drawing erroneous conclusions, due to small sample size and various methodological concerns. The purpose of this randomized controlled trial (RCT) is to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.

Study Type

Interventional

Enrollment (Actual)

290

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Subjects were invited to participate in accordance with the Guidelines for Chiropractic Quality Assurance and Practice Parameters: proceedings of the Mercy Center Consensus Conference, Gaithersburg, MD, 1993, Aspen Publishers Inc.

Additionally and specifically for this RCT:

  1. Both male and female subjects age 18 years and older were invited to participate
  2. Subjects must not be pregnant
  3. Subjects must not have any recent or current fractures of the arms or legs
  4. Subjects must not have any visceral or abdominal condition such that being in the prone position would be detrimental to their health
  5. Subjects must not have any known primary cancers of the spine or spinal column, nor any secondary metastatic process of the spine or spinal column
  6. Subjects must not be under the influence of drugs or alcohol
  7. Subjects must not have vertigo or any other imbalance condition
  8. Subjects must not have any arm or leg prosthetic device
  9. Subjects must be able to understand spoken and/or written Spanish and/or English

Exclusion Criteria:

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control
Control -- no intervention
No Intervention: Placebo w/ sham
Sham intervention with the adjusting tool turned "off"
Experimental: Activator treatment
Treatment with Activator
Device: Activator IV Adjusting Instrument
Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR
Other Names:
  • Activator adjusting instrument
  • http://www.activator.com/products-page/

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.
Time Frame: Baseline, pre-adjustment, post-adjustment
OBJECTIVE: Previous studies on the effects of chiropractic treatment on blood pressure (BP) and pulse rate (PR) have reported decreases in both systolic and diastolic BP, as well as PR. However, many of those studies have been criticized for various study flaws, and accused of drawing erroneous conclusions, due to small sample size and various methodological concerns. The purpose of this randomized controlled trial (RCT) was to measure the effects of specific thoracic (T5 to T1) chiropractic adjustments on BP and PR in a larger sample size of both normotensive and hypertensive humans.
Baseline, pre-adjustment, post-adjustment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Spinal Missions, Inc., LLC

Investigators

  • Principal Investigator: Steven D. Roffers, DC, Spinal Missions, Inc., LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2010

Primary Completion (Actual)

February 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

April 30, 2012

First Submitted That Met QC Criteria

May 2, 2012

First Posted (Estimate)

May 4, 2012

Study Record Updates

Last Update Posted (Estimate)

May 4, 2012

Last Update Submitted That Met QC Criteria

May 2, 2012

Last Verified

May 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SM001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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