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

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.

Condition or disease	Intervention/treatment	Phase
Hypertension	Device: Activator IV Adjusting Instrument	Phase 1

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 Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	290 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Double (Participant, Investigator)
Primary Purpose:	Treatment
Official Title:	A Randomized Controlled Trial to Measure the Effects of Specific Thoracic Chiropractic Adjustments on Blood Pressure and Pulse Rate
Study Start Date :	January 2010
Actual Primary Completion Date :	February 2010
Actual Study Completion Date :	March 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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/

Outcome Measures

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Primary Outcome Measures :

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. [ 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.

Eligibility Criteria

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Ages Eligible for Study:	18 Years to 90 Years (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes

Criteria

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:

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Sponsors and Collaborators

Spinal Missions, Inc., LLC

Investigators

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

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Dr. Steven D. Roffers, Director of Research, Spinal Missions, Inc., LLC
ClinicalTrials.gov Identifier:	NCT01591967 History of Changes
Other Study ID Numbers:	SM001
First Posted:	May 4, 2012
Last Update Posted:	May 4, 2012
Last Verified:	May 2012

Keywords provided by Dr. Steven D. Roffers, Spinal Missions, Inc., LLC:

Chiropractic; Blood pressure; Pulse Rate; Thoracic