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

NCT01591967 | Completed Phase 1 DMC

• 1 other identifier: SM001
• Study Type: interventional
• Target: 290
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Hypertension

Keywords

Chiropractic; Blood pressure; Pulse Rate; Thoracic

Outcome Measures

Primary Outcomes (1)

• 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.

  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

Study Arms (3)

Control

NO INTERVENTION

Control -- no intervention

Placebo w/ sham

NO INTERVENTION

Sham intervention with the adjusting tool turned "off"

Activator treatment

EXPERIMENTAL

Treatment with Activator

Device: Activator IV Adjusting Instrument

Interventions

Activator IV Adjusting Instrument DEVICE

Activator (http://www.activator.com/products-page/) adjustment effects on BP and PR

Also known as: Activator adjusting instrument, http://www.activator.com/products-page/

Activator treatment

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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:
• Both male and female subjects age 18 years and older were invited to participate
• Subjects must not be pregnant
• Subjects must not have any recent or current fractures of the arms or legs
• Subjects must not have any visceral or abdominal condition such that being in the prone position would be detrimental to their health
• 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
• Subjects must not be under the influence of drugs or alcohol
• Subjects must not have vertigo or any other imbalance condition
• Subjects must not have any arm or leg prosthetic device
• Subjects must be able to understand spoken and/or written Spanish and/or English

Sponsors & Collaborators

• Spinal Missions, Inc., LLC: lead

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Study Officials

• Steven D. Roffers, DC

  Spinal Missions, Inc., LLC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Research

Study Record Dates

• First Submitted: April 30, 2012
• First Posted: May 4, 2012
• Study Start: January 1, 2010
• Primary Completion: February 1, 2010
• Study Completion: March 1, 2010
• Last Updated: May 4, 2012

Record last verified: 2012-05